1.0
PURPOSE:
To provide a detailed procedure for the visitors entry / exit through secondary change room.
2.0
SCOPE:
Applicable to all visitors entering and leaving production area located on first floor.
3.0
RESPONSIBILITY:
Personnel department and Management staff
4.0
ACCOUNTABILITY:
Plant Head
5.0
DEFINITIONS:
Nil
6.0
PROCEDURE:
6.1
ENTRY PROCEDURE:
6.1.1
Proceed from primary corridor to enter the secondary change room.
6.1.2
The responsible person accompanying the visitor will swipe the access card to enter the secondary change room.
6.1.3
Wear the second shoe cover over the first shoe cover while crossing over the crossover bench.
6.1.4
Collect secondary over gown and disposable nose mask Wear the secondary over gown.
6.1.5
Disinfect your hands with the disinfectant.
6.1.6
Push the door and enter secondary corridor.
6.2
EXIT PROCEDURE:
6.2.1
Pull the door and enter secondary change room.
6.2.2
Remove the secondary over gown and drop it in the waste bin.
6.2.3
Remove the nose mask and drop it in the waste bin.
6.2.4
Cross the cross over bench.
6.2.5
Proceed towards the exit of secondary change room.
6.2.6
Pull the door and reach the corridor.
7.0
REFERENCES:
Nil
8.0
ENCLOSURES:
Nil
9.0
ABBREVIATIONS:
Nil
Tuesday, July 29, 2008
SOP - ENTRY / EXIT PROCEDURE FOR VISITORS - PRIMARY CHANGE ROOM
1.0
PURPOSE:
To provide a detailed procedure for the visitors entry / exit through primary change room.
2.0
SCOPE:
Applicable to the visitors entering and leaving production area.
3.0
RESPONSIBILITY:
All Employees and Management Staff.
4.0
ACCOUNTABILITY:
Plant Manager
5.0
DEFINITIONS:
Nil
6.0
PROCEDURE:
6.1
ENTRY PROCEDURE:
6.1.1
Enter into the building through the reception main door.
Report the belongings like watches, ornaments, mobile phones, handbag and briefcase etc.
6.1.2
If required use the toilet, washbasins and hand drier located before entering the change room.
6.1.3
Push the door to enter the change room.
6.1.4
Collect the clean primary uniform (Cap, overcoat) from the cabinet.
6.1.5
Wear the clean primary uniform.
6.1.6
Wear the disposable shoe cover on the street footwear while crossing the cross over bench.
6.1.7
Ensure for complete covering of hair including ears and uniform is properly fastened.
6.1.8
Disinfect your hands using disinfectant.
6.1.9
Pull the door to enter primary corridor.
6.2
EXIT PROCEDURE:
6.2.1
Push the door to enter the primary change room.
6.2.2
Drop the used uniform (Cap, overcoat) in bin provided in primary change room for washing.
6.2.3
Cross the crossover bench
6.2.4
Remove the disposable shoe cover.
6.2.5
Drop the used shoe cover in the compartment provided.
6.2.6
Pull the door and exit.
6.2.7
Collect the deposited belongings from the receptionist.
7.0
REFERENCES:
Nil
8.0
ENCLOSURES :
Nil
9.0
ABBREVIATIONS:
Nil
PURPOSE:
To provide a detailed procedure for the visitors entry / exit through primary change room.
2.0
SCOPE:
Applicable to the visitors entering and leaving production area.
3.0
RESPONSIBILITY:
All Employees and Management Staff.
4.0
ACCOUNTABILITY:
Plant Manager
5.0
DEFINITIONS:
Nil
6.0
PROCEDURE:
6.1
ENTRY PROCEDURE:
6.1.1
Enter into the building through the reception main door.
Report the belongings like watches, ornaments, mobile phones, handbag and briefcase etc.
6.1.2
If required use the toilet, washbasins and hand drier located before entering the change room.
6.1.3
Push the door to enter the change room.
6.1.4
Collect the clean primary uniform (Cap, overcoat) from the cabinet.
6.1.5
Wear the clean primary uniform.
6.1.6
Wear the disposable shoe cover on the street footwear while crossing the cross over bench.
6.1.7
Ensure for complete covering of hair including ears and uniform is properly fastened.
6.1.8
Disinfect your hands using disinfectant.
6.1.9
Pull the door to enter primary corridor.
6.2
EXIT PROCEDURE:
6.2.1
Push the door to enter the primary change room.
6.2.2
Drop the used uniform (Cap, overcoat) in bin provided in primary change room for washing.
6.2.3
Cross the crossover bench
6.2.4
Remove the disposable shoe cover.
6.2.5
Drop the used shoe cover in the compartment provided.
6.2.6
Pull the door and exit.
6.2.7
Collect the deposited belongings from the receptionist.
7.0
REFERENCES:
Nil
8.0
ENCLOSURES :
Nil
9.0
ABBREVIATIONS:
Nil
SOP - ENTRY / EXIT PROCEDURE FOR GENTS / LADIES - SECONDARY CHANGE ROOM
1.0
PURPOSE:
To provide a written procedure for the entry / exit through secondary change room.
2.0
SCOPE:
Applicable to all personnel (gents and ladies) entering and leaving production area.
3.0
RESPONSIBILITY:
All Employees.
4.0
ACCOUNTABILITY:
Plant Manager
5.0
DEFINITIONS:
Nil
6.0
PROCEDURE:
6.1
ENTRY PROCEDURE:
6.1.1
Proceed from primary corridor, swipe the access card and enter the secondary change room
6.1.2
Remove primary footwear and store in the primary footwear storage compartment in the cross over bench.
6.1.3
Cross the cross over bench.
6.1.4
Collect secondary wear from the secondary uniform lockers.
Gents : Boiler suit and snood
Ladies : Over gown and snood
Department : Colour code
Production : Light green
Quality assurance : Cream
Quality control : White
Stores : Sky blue
Maintenance : Navy blue
House keeping : Light blue
6.1.5
Wear snood over the primary cap and tie the knot.
6.1.6
Wear the boiler suit / over gown inserting the hanging flaps of snood.
6.1.7
Collect the secondary footwear (shoe) from the secondary footwear storage compartment and wear them.
6.1.8
Check for complete covering and uniform properly fastened.
6.1.9
Disinfect your hands using disinfectant.
6.1.10
Push the door and enter the secondary corridor.
6.2
PROCEDURE FOR EXIT DURING LUNCH BREAK:
6.2.1
Pull the door and enter secondary change room.
6.2.2
Remove the secondary footwear and store in the cross over bench compartment.
6.2.3
Remove the boiler suit / over gown and snood; keep it folded in the locker provided.
6.2.4
Collect the primary footwear and wear while crossing the cross over
bench
6.2.5
Open the exit door of the change room and reach the corridor.
6.3
PROCEDURE FOR EXIT AFTER SHIFT ENDS:
6.3.1
Follow same procedure as mentioned under point no. 6.2.1 to 6.2.5, follow 6.3.2 in place of 6.2.3
6.3.2
Drop the used boiler suit/ over gown and snood in the bin provided in secondary change room for washing.
7.0
REFERENCES:
Nil
8.0
ENCLOSURES:
Nil
9.0
ABBREVIATIONS:
Nil
PURPOSE:
To provide a written procedure for the entry / exit through secondary change room.
2.0
SCOPE:
Applicable to all personnel (gents and ladies) entering and leaving production area.
3.0
RESPONSIBILITY:
All Employees.
4.0
ACCOUNTABILITY:
Plant Manager
5.0
DEFINITIONS:
Nil
6.0
PROCEDURE:
6.1
ENTRY PROCEDURE:
6.1.1
Proceed from primary corridor, swipe the access card and enter the secondary change room
6.1.2
Remove primary footwear and store in the primary footwear storage compartment in the cross over bench.
6.1.3
Cross the cross over bench.
6.1.4
Collect secondary wear from the secondary uniform lockers.
Gents : Boiler suit and snood
Ladies : Over gown and snood
Department : Colour code
Production : Light green
Quality assurance : Cream
Quality control : White
Stores : Sky blue
Maintenance : Navy blue
House keeping : Light blue
6.1.5
Wear snood over the primary cap and tie the knot.
6.1.6
Wear the boiler suit / over gown inserting the hanging flaps of snood.
6.1.7
Collect the secondary footwear (shoe) from the secondary footwear storage compartment and wear them.
6.1.8
Check for complete covering and uniform properly fastened.
6.1.9
Disinfect your hands using disinfectant.
6.1.10
Push the door and enter the secondary corridor.
6.2
PROCEDURE FOR EXIT DURING LUNCH BREAK:
6.2.1
Pull the door and enter secondary change room.
6.2.2
Remove the secondary footwear and store in the cross over bench compartment.
6.2.3
Remove the boiler suit / over gown and snood; keep it folded in the locker provided.
6.2.4
Collect the primary footwear and wear while crossing the cross over
bench
6.2.5
Open the exit door of the change room and reach the corridor.
6.3
PROCEDURE FOR EXIT AFTER SHIFT ENDS:
6.3.1
Follow same procedure as mentioned under point no. 6.2.1 to 6.2.5, follow 6.3.2 in place of 6.2.3
6.3.2
Drop the used boiler suit/ over gown and snood in the bin provided in secondary change room for washing.
7.0
REFERENCES:
Nil
8.0
ENCLOSURES:
Nil
9.0
ABBREVIATIONS:
Nil
SOP - PROCEDURE FOR MEDICAL CHECK UP
1.0
PURPOSE :
To provide a written procedure for the medical check up.
2.0
SCOPE :
Applicable to all employees joining the company.
3.0
RESPONSIBILITY:
Registered Medical Officer , Human Resource Executive
4.0
ACCOUNTABILITY:
Human Resource Manager
5.0
DEFINITIONS:
Nil.
6.0
PROCEDURE :
6.1
Company should make a contract with Registered Medical Officer for checking physical fitness of the employees.
6.2
Every new recruit should under go medical examination before joining the company.
6.3
Medical examination should be carried out once in a year for all the employees.
6.4
Medical examination should include the tests like
Hb, TC, DC, ESR, Chest PA X-ray, ECG, Urine RE,RBS and urea- Package I
Penicillin Allergic test Package II
6.5
Employee should not report to the work if they are infected with any disease or they have any open lesions.
6.6
About illness during working hours employee should report to his/her department head. Department Head would decide about his /her continuation of the days work.
7.0
REFERENCES:
Nil
8.0
ENCLOSURES:
Nil
9.0
ABBREVIATION:
9.1
HR: human resource
PURPOSE :
To provide a written procedure for the medical check up.
2.0
SCOPE :
Applicable to all employees joining the company.
3.0
RESPONSIBILITY:
Registered Medical Officer , Human Resource Executive
4.0
ACCOUNTABILITY:
Human Resource Manager
5.0
DEFINITIONS:
Nil.
6.0
PROCEDURE :
6.1
Company should make a contract with Registered Medical Officer for checking physical fitness of the employees.
6.2
Every new recruit should under go medical examination before joining the company.
6.3
Medical examination should be carried out once in a year for all the employees.
6.4
Medical examination should include the tests like
Hb, TC, DC, ESR, Chest PA X-ray, ECG, Urine RE,RBS and urea- Package I
Penicillin Allergic test Package II
6.5
Employee should not report to the work if they are infected with any disease or they have any open lesions.
6.6
About illness during working hours employee should report to his/her department head. Department Head would decide about his /her continuation of the days work.
7.0
REFERENCES:
Nil
8.0
ENCLOSURES:
Nil
9.0
ABBREVIATION:
9.1
HR: human resource
SOP - ENTRY / EXIT PROCEDURE FOR GENTS / LADIES - PRIMARY CHANGE ROOM
1.0
PURPOSE:
To provide a written procedure for the entry / exit through primary change room.
2.0
SCOPE:
Applicable to all personnel (Gents and Ladies) entering and leaving production area .
3.0
RESPONSIBILITY:
All employees.
4.0
ACCOUNTABILITY:
Plant Manager.
5.0
DEFINITIONS:
Nil
6.0
PROCEDURE:
6.1
ENTRY PROCEDURE:
6.1.1
Remove the street footwear and keep them in the street footwear racks/ Cupboards.
6.1.2
If required use the toilet and washbasins located beside the main door before removing the street foot wear.
6.1.3
Push the door and enter the first change room.
6.1.4
Keep the personnel belongings in the lockers provided.
6.1.5
Remove street clothes and keep them in the street clothes lockers provided.
6.1.6
Wash your hands in the wash tap provided.
6.1.7
Dry your hands using hand drier.
6.1.8
Cross the crossover bench and enter the second change room.
6.1.9
Collect the clean primary uniform from the locker provided and wear.
Gents: Pant, Shirt and cap.
Ladies: Churidhar and cap.
Department :
Colour code
Production : White
Quality assurance : Cream
Quality control : White
Stores : Sky blue
Maintenance : Navy blue
House keeping : Light blue
6.1.10
Collect the primary footwear from the locker provided and wear.
6.1.11
Check for complete covering of hair including ears and uniform properly fastened.
6.1.12
Disinfect your hands using disinfectant.
6.1.13
Pull the door and enter primary corridor.
6.2
PROCEDURE FOR EXIT DURING LUNCH BREAK:
6.2.1
Push the door and enter the primary change room.
6.2.2
Remove the primary footwear and store in the locker provided.
6.2.3
Remove the primary uniform and store in the locker provided.
6.2.4
Cross the crossover bench and enter the first change room.
6.2.5
Open the street cloth locker and wear street clothes.
6.2.6
Pull the door to reach the main door entry corridor.
6.2.7
Open the street footwear locker and wear the street footwear.
6.2.8
Exit from the main door.
6.3
PROCEDURE FOR EXIT AFTER SHIFT ENDS:
6.3.1
Follow same procedure as mentioned under point no. 6.2.1 to 6.2.8, follow 6.3.2 instead of 6.2.3.
6.3.2
Drop the used uniform in bin provided in primary change room for washing.
7.0
REFERENCES:
Nil
8.0
ENCLOSURES:
Nil
9.0
ABBREVIATIONS:
Nil
PURPOSE:
To provide a written procedure for the entry / exit through primary change room.
2.0
SCOPE:
Applicable to all personnel (Gents and Ladies) entering and leaving production area .
3.0
RESPONSIBILITY:
All employees.
4.0
ACCOUNTABILITY:
Plant Manager.
5.0
DEFINITIONS:
Nil
6.0
PROCEDURE:
6.1
ENTRY PROCEDURE:
6.1.1
Remove the street footwear and keep them in the street footwear racks/ Cupboards.
6.1.2
If required use the toilet and washbasins located beside the main door before removing the street foot wear.
6.1.3
Push the door and enter the first change room.
6.1.4
Keep the personnel belongings in the lockers provided.
6.1.5
Remove street clothes and keep them in the street clothes lockers provided.
6.1.6
Wash your hands in the wash tap provided.
6.1.7
Dry your hands using hand drier.
6.1.8
Cross the crossover bench and enter the second change room.
6.1.9
Collect the clean primary uniform from the locker provided and wear.
Gents: Pant, Shirt and cap.
Ladies: Churidhar and cap.
Department :
Colour code
Production : White
Quality assurance : Cream
Quality control : White
Stores : Sky blue
Maintenance : Navy blue
House keeping : Light blue
6.1.10
Collect the primary footwear from the locker provided and wear.
6.1.11
Check for complete covering of hair including ears and uniform properly fastened.
6.1.12
Disinfect your hands using disinfectant.
6.1.13
Pull the door and enter primary corridor.
6.2
PROCEDURE FOR EXIT DURING LUNCH BREAK:
6.2.1
Push the door and enter the primary change room.
6.2.2
Remove the primary footwear and store in the locker provided.
6.2.3
Remove the primary uniform and store in the locker provided.
6.2.4
Cross the crossover bench and enter the first change room.
6.2.5
Open the street cloth locker and wear street clothes.
6.2.6
Pull the door to reach the main door entry corridor.
6.2.7
Open the street footwear locker and wear the street footwear.
6.2.8
Exit from the main door.
6.3
PROCEDURE FOR EXIT AFTER SHIFT ENDS:
6.3.1
Follow same procedure as mentioned under point no. 6.2.1 to 6.2.8, follow 6.3.2 instead of 6.2.3.
6.3.2
Drop the used uniform in bin provided in primary change room for washing.
7.0
REFERENCES:
Nil
8.0
ENCLOSURES:
Nil
9.0
ABBREVIATIONS:
Nil
SOP - RECRUITMENT POLICY, JOB DESCRIPTION AND QUALIFICATION
1.0 PURPOSE:
To provide a standard procedure for Recruitment Policy.
2.0 SCOPE:
This procedure is applicable for the recruitment, selection and placement of an employee
in XXXXX company
3.0 RESPONSIBILITY:
HR Manager (Corporate office)
HR Executive
4.0 ACCOUNTABILITY:
Plant Manager
GM Quality Assurance
5.0 DEFINITIONS:
Nil
6.0 PROCEDURE:
6.1 In order to have right person for the right job, selection procedures have been defined.
6.2 For Pharmaceutical Industry the following departments have been identified.
a) Human Resources
b) Stores
c) Manufacturing
d) Packaging
e) Quality Control
f) Quality Assurance
g) Regulatory Affairs
i) Maintenance
j) House Keeping
6.3 In order to elaborate and explain the responsibilities of each department head and their subordinates and to cover all functions and authorities the following is the organization chart adopted with required Qualification, Experience and number of positions in each department.
6.4 GM QUALITY ASSURANCE
QUALIFICATION REQUIRED: B.Pharm / B.Sc (Chemistry) / M.Pharm / M.Sc
(Chemistry) from a reputed University.
EXPERIENCE: Minimum 10 years of experience in a QA and QC department in reputed Pharma industries. Excellent communication /expression and co- ordination skills to lead a team of managers and executives to achieve the desired results. To propose, suggest and to improve the Quality of the product and other techniques as per the expectation of management.
RESPONSIBILITIES:
. Shall be overall in charge of QA, QC and Regulatory Affairs and shall report to CEO.
· Shall organize plant control and coordinate all the functional areas of the plant.
· Shall review QA,QC and RAD functions regularly and take necessary steps for improving the quality of the products, techniques and the implementations of cGMP for effective quality management.
· Shall coordinate with Plant Manager, Manager QA, Manager QC and Regulatory Affairs for obtaining the manufacturing licences and necessary certificates for our formulations and renewal of licences from the Drug Control Authority.
Is responsible for improving and strengthening the quality system and documentation requirements and for cGMP.
· Shall coordinate with corporate office and other manufacturing units of the organization regarding technical matters related to products, processes and other technical issues.
6.5 PLANT MANAGER:
QUALIFICATION REQUIRED : B.Pharm / M.Pharm from a reputed University.
EXPERIENCE: Minimum 10 years of Practical experience in a Production department in a reputed Pharmaceutical Industries. Excellent Communications/Expression and Co-ordination skills – to lead a team of Managers and executives to achieve
the desired results. To propose, suggest and to improve the Production, Excellent leader ship qualities and other techniques as per the expectation of management.
DUTIES AND RESPONSIBILITIES:
Plant manager is the Overall in-charge of the Plant activities which include planning, organization, Direction and control of the activities of the industry and to lead the team.
Shall report to the Managing Director and shall control the team members, which includes Departmental Managers, executives and Operators.
To plan for the Raw Materials & Packing Materials for the products to be manufactured.
Co-ordination of the activities of all the departments for smooth functioning.
Plant Manager is responsible for improvement of the Production activities, development of new product, verification & modification of the existing Production activities.
Is responsible for maintenance of records & register and submission of any periodical return to the regulatory authorities, wherever required.
To direct the H.R.D. for Manpower planning.
To initiate training to executives and also encourage basic training for workmen by executives involved in respective departments.
6.6 EXECUTIVE HUMAN RESOURCES:
QUALIFICATION REQUIRED: Any Bachelor Degree
EXPERIENCE : 6 months experience in any Industrial undertakings, in the field of
Human Resources Management.
Others : Well versed in English and local language.
DUTIES AND RESPONSIBILITIES:
Shall report to Plant Manager.
Shall co-ordinate with HR Manager at Corporate office regarding all HR activities at the site.
Shall maintain Time Office Management.
Shall maintain Personnel files.
Shall monitor Security and House keeping activities.
Shall update all statutory records and registers as per factories act.
Shall update Muster Roll register and leave with wage register.
Shall responsible for statutory compliances and returns to Labour department/Inspector of factories and other Government departments as when required.
6.7 ASSISTANT MANAGER STORES:
QUALIFICATION REQUIRED: Any degree with Diploma in Materials
Management
EXPERIENCE: Minimum two years experience in any industry, preferably in
Pharma industry, good knowledge of English and Local language.
DUTIES AND RESPONSIBILITIES:
Assistant Manager Stores shall report to Plant Manger and is overall in charge of the stores.
To monitor and execute the stores operations and report to Plant Manager.
Shall procure Raw materials and Packing materials from Head office and prepare relative documents.
Shall control receipt and issue of Raw materials and Packing materials.
Shall ensure the daily activities are updated in respective records.
Shall prepare monthly stock statements of Raw materials and Packing materials.
Shall ensure Good manufacturing Practice during receipt and issue of Raw materials and packing materials.
Shall provide on job training as per SOP’s to stores personnel.
6.8 OFFICER STORES:
QUALIFICATION REQUIRED: H.S.C. / Any Degree
EXPERIENCE: 1 year in Stores department in any industry, Good knowledge of
English & Local language.
DUTIES AND RESPONSIBILITIES:
Officer Stores reports duty to Assistant Manager Stores.
To check the condition of the vehicle and receive the goods as per Standard Operating Procedure.
Shall prepare relative documents and updation for receiving goods.
Shall arrange the Raw/Packing Materials such a manner and batch wise with status of materials.
Shall receive the requisition from manufacturing/packing department and dispense the required quantities as per mentioned in the requisition.
Shall train the stores personnel and implementation the new systems as per cGMP.
Shall monitor and execute the daily activity as per Standard Operating Procedure and report to Assistant Manager Stores.
Responsible for all activities in the department in absence of Asst.Manager Stores.
6.9 HELPERS STORES:
QUALIFICATION REQUIRED : S.S.L.C.
EXPERIENCE : Fresh
OTHERS : Minimum Knowledge of Local language and English read & write.
DUTIES AND RESPONSIBILITIES:
Helpers shall take instructions from the Stores officer/ Assistant Manager Stores
To assist the stores officer in all respects.
Also responsible to maintain cleanliness.
6.10 ASSISTANT MANAGER MANUFACTURING:
QUALIFICATION REQUIRED : B.Pharm/M.Pharm
EXPERIENCE : Minimum 5 years Experience in manufacturing department in
Pharma Industry.
OTHERS : An excellent communication skills and good grasp of local
language, fluency in English, well versed in Co-ordination of
activities – Commanding knowledge and control.
DUTIES AND RESPONSIBILITIES:
Overall in charge of manufacturing activities in the department, and shall report to Plant Manager.
Responsible for the use of international and national standard codes available and applicable to the manufacturing activities.
Responsible for identification and verification, regarding process of the products in consultation with Plant Manger.
Responsible for development of any new product in consultation with Plant Manager/ Manager QC.
Responsible for implementing the cGMP in manufacturing area strictly.
Responsible for all the documents to be maintained in manufacturing department and to report to the Plant Manager.
Shall co-operate with HRD Department for organizing the trainings program for department operators and helpers accordingly.
Responsible for adherence to SOP. and ensure that same are implemented by all the staff members & employees in the department.
Responsible for sanctioning leave and maintaining discipline in the department.
In the absence of Plant Manager, Assistant Manager Manufacturing shall be responsible for all the concerned activities.
6.11 SENIOR EXECUTIVES MANUFACTURING:
QUALIFICATION REQUIRED: B.Pharm / M.Pharm
EXPERIENCE : Minimum 2 years Experience in manufacturing department in reputed Pharma Industry.
OTHERS : Good knowledge of English, Tamil preferable.
DUTIES AND RESPONSIBILITIES:
Responsible for the day to day planning of the products manufactured in the department in consultation with the Assistant Manager Manufacturing.
Responsible for allocating the work to operators and Co-ordination of the activities.
Responsible for maintaining discipline in the manufacturing area among the operators and helpers working.
To assist the Assistant Manager Manufacturing in all respects.
Responsible for any defects found while manufacturing the product and report to Assistant Manager Manufacturing and assist in rectifying the same.
Responsible for implementing the cGMP’s in consultation with Assistant Manager Manufacturing.
Shall co-operate with HRD Department through Assistant Manager Manufacturing in organizing the training programme for manufacturing department employees.
Is also responsible for all documentation of the department with the consultation of Assistant Manager Manufacturing .
Responsible for planning the shift schedule in consultation with Assistant Manager Manufacturing /Plant Manager.
6.12 JUNIOR EXECUTIVE MANUFACTURING:
QUALIFICATION REQUIRED: B.Pharm /M.Pharm
EXPERIENCE: : Fresh
OTHERS : Good knowledge of English, Tamil preferable.
DUTIES AND RESPONSIBILITIES:
Shall report to Assistant Manager Manufacturing and take instruction from him in respect of day to day production schedule.
Responsible to check for days attendance of workmen and allocate the work.
Responsible to effect any change in production schedule i.e. change in product/Changeover from one product to another with the consultation of senior executives Manufacturing.
Responsible for achieving the production target.
Responsible to solve any operators or helper’s problem with respect to production and if it is beyond his scope of any decision taking, then to take up the matter with executives Manufacturing or Assistant Manager Manufacturing in writing.
Responsible for arranging the raw materials required for the day’s production and arrange for dispensing activity and inform the stores personnel accordingly.
Responsible for allotting work on day to day basis to the staff members, skilled and unskilled workmen and supervise the work of department.
Responsible for labeling of the stage/status of the manufacturing process and labelling of the products.
Shall be responsible for all the concerned activities in the absence of executives Manufacturing.
6.13 OPERATOR MANUFACTURING:
QUALIFICATION REQUIRED: H.S.C. / S.S.L.C.
EXPERIENCE : Fresh
OTHERS : Minimum Knowledge of Local language and English to read &
write.
DUTIES AND RESPONSIBILITIES:
Operators are to take the instructions from shift Executive Manufacturing with regard to day’s manufacturing activities and shall execute the same.
Shall know about the execution of the different stages of manufacturing programmes. If not, they shall learn from Manager/Executive through training programmes.
Shall inform the Executive Manufacturing if any problem in the manufacturing and immediately stop the machine, if necessary.
Responsible for keeping the department and area clean with the help of helpers manufacturing and maintain hygienic condition during the manufacturing and also after manufacturing.
· Responsible for the correct labeling of the product and the process or stage of the manufacturing process.
6.14 HELPERS MANUFACTURING:
QUALIFICATION REQUIRED : S.S.L.C.
EXPERIENCE : Fresh
OTHERS : Minimum Knowledge of Local language and to read & write English
DUTIES AND RESPONSIBILITIES:
Helpers shall take instructions from the Operators/ Executives Manufacturing.
To assist the operators in all respects.
Also responsible to maintain cleanliness.
6.15 MANAGER PACKAGING:
QUALIFICATION REQUIRED: B.Pharm / B.Sc.,
EXPERIENCE : Minimum 3 years experience in packing department in reputed
Pharma industry.
OTHERS : With good communication skills, Good knowledge of English and
local languages. Good expression and command and control
over the staff members & workmen.
DUTIES AND RESPONSIBILITIES:
Overall in charge of Packaging activities in the department, and shall report to Plant Manager.
Responsible for the day to day activities in the strip ,Blister ,Tropical ,Alu-Alu and bulk packing .
To receive the instructions from the Manufacturing department with regards to the product which are manufactured and which are ready for packing.
Responsible to arrange the packing as per the schedule (or) as per the specific instructions.
Responsible to give proper instruction to the department supervisor and Co-ordinate the activities and Co-ordinate with HRD department for organizing Training Programmes.
Responsible to complete the packing of respective batches as per the schedule for the day.
Responsible to maintain the necessary records and co-ordinate with QA/QC department for getting the approval and necessary line clearance for further batches including the packing materials approval.
Responsible to arrange and get the approval packing materials from the stores.
Responsible for investigation in case of any defects in packing.
Responsible for maintaining discipline in the department and resolve the day to day problems if any.
Overall responsible for the Departmental SOP. and its adherence to Periodical improvement of the same.
6.16
SUPERVISOR PACKAGING:
QUALIFICATION REQUIRED: D.Pharm / B.Pharm / Any Degree.
EXPERIENCE :: Minimum 1 year in any industry with exposure to Packing
department.
OTHERS : With good communication skills and good knowledge of English
and the local languages.
DUTIES AND RESPONSIBILITIES:
Supervisor shall take instructions from Manager Packaging and discharge the duties accordingly.
Shall arrange the work for packing operators in different packing area and arrange the packing materials accordingly including the required tablets / capsules based on the packing schedule.
Responsible for maintaining the quality of finished products, and report any defects or problems to the manager Packaging.
Responsible for completing the batches to be packed within the prescribed time schedule.
Responsible to assist the Manager in maintaining the necessary records & registers of the department.
Responsible to get the necessary documents from assistants to co-ordinate with QC and QA Personnel.
Responsible for all activities in the packing department in the absence of Manager.
6.17 OPERATOR PACKAGING:
QUALIFICATION REQUIRED: S.S.L.C.
EXPERIENCE: Fresh
OTHERS : Good knowledge in local language and Should read and write
English.
DUTIES AND RESPONSIBILITIES:
Operator shall take instructions from Supervisor Packaging and discharge the duties accordingly.
To strictly follow the good practice of cleanliness, health and hygiene.
Responsible to keep the work place clean and dust free.
Shall reject the on-line defected Tablets/Capsules/packing materials and inform the same to the Supervisor.
Shall keep the record of weight of bulk tablets received from manufacturing department.
To give foil , PVC, Alu Alu consumption of each batch , reconciliation to be verified.
6.18 MANAGER QUALITY CONTROL:
QUALIFICATION REQUIRED: M.Pharm / B.Pharm / M.Sc./B.Sc.,
EXPERIENCE: Minimum 5 years in Quality Control Department in any reputed
Pharma industry
DUTIES AND RESPONSIBILITIES:
The Manager is overall in charge of the QC activities and shall co-ordinate the activities of all the functional areas in the department. He shall report duty to the GM - QA and organise plant control and co-ordinate the activities of the department.
The Manager has the authority to approve or reject the Raw Materials, Packing materials , intermediates and finished products based on analytical results and has the responsibility to control the non-conforming products.
Responsible for co-coordinating to obtain manufacturing licence for any formulation and renewal of licence with Plant Manager and RAD Manager from the drug control authority.
Responsible for the procurement, maintenance and shall implement necessary National/International Standard and codes.
Shall be responsible for identification, initiating action and verification of effective of corrective action regarding Process/Product in co-ordination with the Assistant Manager Manufacturing.
Responsible for implementation, improvement and modification of analytical techniques for the existing products.
Responsible for developing the analytical procedure for new Products.
Responsible for the stability studies for commercial packs of Marketed products.
Responsible to study the stability of developed products in the package proposal.
Responsible for implementation of Standard Operating Procedures.
Responsible for implementation of training programme in Co-ordination with Plant Manager , HRD Manager and QA Manager.
Responsible for the clearance and destruction of the rejected Raw Materials and Packing Materials.
6.19 ASSISTANT MANAGER QUALITY CONTROL:
QUALIFICATION REQUIRED : M.Pharm/B.Pharm/M.Sc (Chemistry) /
B.Sc(Chemsitry).,
EXPERIENCE : Minimum 5 years in Quality Control Department in any reputed
Pharma Organisation.
DUTIES AND RESPONSIBILITIES :
The Asst.Manager shall report duty to the Manager QC and is responsible for co-ordinating with other departments as well as planning the day to day activities in the department in co-ordination with executives.
To assist the Manager QC in all respects and has to take instruction from him.
Responsible for reviewing of Primary Standards and Working Standards, and modify the same.
Responsible to check the maintenance of the department premises and equipments, in view of cleanliness and good hygiene.
Responsible for reviewing of all Raw Materials, Packing Materials and Finished Products Specification and standard Operating Procedure in co-ordination with Manager QC.
Responsible for all validation works.
To assist Manager QC for developing the analytical methods for new products.
Shall be responsible for all the activities in QC department in the absence of QC Manager.
6.20 SENIOR EXECUTIVE QUALITY CONTROL:
QUALIFICATION REQUIRED : M.Pharm /B.Pharm / M.Sc (Chemistry) /
B.Sc(Chemsitry).,
EXPERIENCE : Minimum 3 years in Quality control Department in any reputed
Pharma Industry.
DUTIES AND RESPONSIBILITIES:
Senior QC Executive shall report duty to Assistant Manager QC and is responsible to assist Asst. Manager in all respects in the QC Department.
Responsible to assist Asst.Manager in validation work.
Responsible for calibration of equipments in the laboratory.
Responsible for all functions in QC Department in the absence of Asst. Manager.
6.21 JUNIOR EXECUTIVE QUALITY CONTROL:
QUALIFICATION REQUIRED : B.Pharm / M.Pharm / B.Sc.,/ M.Sc.,
EXPERIENCE : Minimum 6 months in Quality control Department in any reputed
Pharma Industry.
DUTIES AND RESPONSIBILITIES:
Junior QC Executive shall report duty to Assistant Manager QC and is responsible to assist Asst. Manager in all respects in the QC Department.
Responsible for sampling of Raw materials and Packing materials.
Responsible for analysis of Raw materials, Packing materials, intermediates, finished products and stability samples.
Responsible for preparation and storage of volumetric solutions, reagents and indicators.
Responsible for all activities in department in the absence of senior QC executive.
6.22 MICROBIOLOGIST :
QUALIFICATION REQUIRED : B.Sc./ M.Sc., (Microbiology)
EXPERIENCE : Minimum 2 years in Microbiological Laboratory in any
Pharma Industry.
DUTIES AND RESPONSIBILITIES:
Microbiologist shall report to Assistant Manager QC.
Responsible for all Microbiological analysis of Raw Materials, Finished Products, Water Analysis, Fumigation works and Packing materials.
Responsible for all the cleaning validation and environmental control activities.
Responsible for reviewing all documents regarding microbiology.
Shall co-ordinate with concerned department while fumigation is done in the factory.
6.23 MANAGER QUALITY ASSURANCE :
QUALIFICATION REQUIRED : M.Pharm /B.Pharm/ M.Sc (Chemistry) /
B.Sc (Chemsitry).,
EXPERIENCE : Minimum 5 years in Quality Assurance /Quality Control
Department in any reputed Pharma industry.
DUTIES AND RESPONSIBILITIES:
The Manager is overall incharge of the QA activities and shall co-ordinate the activities of all the functional areas in the department. He shall report duty to the GM Quality Assurance
To maintain and control an overall Quality Management System documentation.
Responsible for planning, co-ordination and implementing internal audit/vendor audit/Quality training programme.
To review and approve the Batch Manufacturing Record and Batch Packaging Record.
Responsible for investigation of Market complaints.
To review and approve the Qualification and validation documents.
Responsible for Batch release.
To initiate action to solve non conformance.
To organise review meeting and document their actions and corrective measures implemented for GMP requirements.
Responsible for implementation of GMP requirements.
He is nominated by management as GMP administrator.
6.24 ASSISTANT MANAGER QUALITY ASSURNCE :
QUALIFICATION REQUIRED : M.Pharm/B.Pharm/M.Sc (Chemistry) /
B.Sc(Chemsitry).,
EXPERIENCE : Minimum 5 years in Quality Assurance /Quality control Department in any reputed Pharma industry.
DUTIES AND RESPONSIBILITIES:
The Asst.Manager shall report duty to the QA Manager and is responsible for co-ordinating with other departments as well as planning the day to day activities in the department in co-ordination with executives.
Responsible for Document control cell, review of documents, draft circulation and finalization to prepare master documents.
To co ordinate for validation activities, compile necessary records for the same.
Responsible for all QA activities in absence of Manager QA.
To monitor the IPQA activities, review and report to the Manager.QA
6.25 SENIOR EXECUTIVE QUALITY ASSURANCE:
QUALIFICATION REQUIRED : M.Pharm/B.Pharm/M.Sc (Chemistry) /
B.Sc (Chemsitry).
EXPERIENCE : Minimum 3 years experience in Quality Assurance /Quality
Control Department in any reputed Pharma industry.
DUTIES AND RESPONSIBILITIES:
Senior Executive QA shall report duty to Assistant Manager QA.
Responsible for co-ordinating with production, QC and Maintenance for carrying out validation studies and equipment qualification.
Responsible to prepare Drug Master File (DMF).
Responsible for issuing Batch Manufacturing Record and Batch Packaging Record.
Responsible for monitoring the records of IPQA activities.
To monitor the compliance of standard operating procedure.
6.26 JUNIOR EXECUTIVE QUALITY ASSURANCE :
QUALIFICATION REQUIRED : M.Pharm/B.Pharm/M.Sc (Chemistry) /
B.Sc (Chemsitry).,
EXPERIENCE : Minimum 6 months experience in Quality Assurance /Quality
Control Department in any reputed Pharma industry.
DUTIES AND RESPONSIBILITIES:
Junior QA executive shall report duty to Assistant QA Manager.
Responsible for co-ordinating with QC and manufacturing for carrying out validation studies and equipment qualification.
Responsible for all IPQA activities.
Responsible for Line clearance in Stores , Manufacturing and Packing line , In process sampling and intermediate release activities .
To monitor the compliance of standard operating procedure.
6.27 MANAGER REGULATORY AFFAIRS:
QUALIFICATION REQUIRED : M.Pharm/B.Pharm/M.Sc (Chemistry) /
B.Sc (Chemsitry).,
EXPERIENCE : Minimum 5 years in Regulatory Affairs department in any reputed Pharma industry.
DUTIES AND RESPONSIBILITIES:
· The Manager RAD is overall in charge of the Regulatory activities and shall co-ordinate the activities of all the functional areas in the department. He shall report duty to the GM QA.
· Responsible for preparation of Technical Dossiers as per guidelines of importing countries .
· To co- ordinate with Production, QC, QA and provide samples for Tender and Registration purpose.
· Apply and obtain certificates and permission required from Drug control department like No Objection Certificate.
· Coordinating with Quality Control and apply for additional endorsement and to ensure the availability of endorsements in the manufacturing licences.
· Replying to Queries related to Reg
· istration as per requirements of importing countries.
· Obtaining attestation from embassies of various countries .
· Apply and obtain Certificate Of Pharmaceutical Product & Free Sale Certificate from Drug Control, Tamil Nadu.
· Label and Artwork verification on regulatory requirements.
6.28 EXECUTIVE REGULATORY AFFAIRS :
QUALIFICATION REQUIRED : M.Pharm/B.Pharm/M.Sc./B.Sc.,
EXPERIENCE : Minimum 6 months experience in Regualtory affairs Department
In any reputed Pharma industry.
DUTIES AND RESPONSIBILITIES:
The Executive Regulatory affairs shall report duty to the Manager RAD and is responsible for co-ordinating with other departments .
To assist Manager RAD for the preparation of Technical Dossiers as per guidelines of importing countries.
To co- ordinate with Production, QC, QA and provide samples for Tender and Registration purpose.
Apply and obtain certificates and permission required from Drug control department like No Objection Certificate.
Coordinating with Quality Control and apply for additional endorsement and to ensure the availability of endorsements in the manufacturing licences.
Apply and obtain Certificate Of Pharmaceutical Product & Free Sale Certificate from Drug Control, Tamil Nadu.
Label and Artwork verification on regulatory requirements.
6.29 ASSISTANT MANAGER MAINTENANCE :
QUALIFICATION REQUIRED : B.E./ D.M.E. / D.E.E..
EXPERIENCE : Minimum 5 years of experience in Maintenance department in
reputed Pharma Industry.
DUTIES AND RESPONSIBILITIES:
Assistance Manager Maintenance shall report duty to Plant Manager.
To assist the Assistant Manager Manufacturing/Plant Manager in all the maintenance work.
To help Plant Manager in the day to day work of factory premises.
To help Plant Manager to conduct/organize the training program as and when required.
To co-ordinate project/renovation work in the factory.
To plan all Preventive Maintenance and break down maintenance activities.
Responsible for procuring the Machinery spare parts for equipments.
Responsible to prepare Qualification and validation of all equipments and maintain relevant documents and records.
6.30 MAINTENANCE ENGINEER:
QUALIFICATION REQUIRED : B.E./D.M.E. / D.E.E..
EXPERIENCE: Minimum 2 years of experience in Maintenance Department in
reputed Pharma Industry.
DUTIES AND RESPONSIBILITIES:
Engineer Maintenance has to report duty to Assistant Manager maintenance.
Responsible for co-coordinating with production, QC and QA for carrying out validation studies and equipment qualification.
To attend all Preventive Maintenance and break down maintenance activities.
To maintain the machinery spare parts for equipments.
6.31 MAINTENANCE TECHNICIAN:
QUALIFICATION REQUIRED : I.T.I. (Mechanical/Electrical)
EXPERIENCE :: Minimum 6 months of experience in Maintenance department in
Pharma Industry.
DUTIES AND RESPONSIBILITIES :
Maintenance Technician has to report duty to Assistant Manager maintenance.
Maintenance Technician has to assist the maintenance engineer in day to day work.
Shall know how to execute the different stages of Maintenance activities. If not, they shall learn from Maintenance engineer through training programmes.
To inform Maintenance engineer in regard to any breakdown of machine or any other machinery problems and to take necessary action in this regards for proper rectification.
To maintain all utility equipments, air compressor, generator & electrical work etc.,
6.32 SUPERVISOR HOUSE KEEPING:
QUALIFICATION REQUIRED : HSC / Any Degree.
EXPERIENCE : 1 – 2 years of experience in relevant field.
DUTIES AND RESPONSIBILITIES:
House keeping supervisor shall report to Plant Manager and he shall co-ordinate with HR Department & Maintenance Department for House keeping activities.
Overall in charge of all the good house keeping activities of the plant.
Shall be responsible to cover house keeping of external, peripheral and internal production areas.
Shall comply house keeping standards on par with good manufacturing practice.
Shall be responsible for Pest & Rodent control activities.
Shall give proper training regarding sanitation to the personnel involved in cleaning.
Shall maintain House keeping records.
7.0 REFERENCES:
Nil
8.0 ENCLOSURES:
Nil
9.0 ABBREVIATIONS:
9.1 CEO: Chief Executive Officer
9.2 RAD: Regulatory Affairs Department
9.3 GM: General Manager
9.4 QA: Quality Assurance
9.5 IPQA: In process Quality Assurance
9.6 QC: Quality Control
9.7 HRD: Human Resources Department
9.8 SOP: Standard Operating Procedure
9.9 B.Pharm: Bachelor of Pharmacy
9.10 M.Pharm: Master of Pharmacy
9.11 D.Pharm: Diploma in Pharmacy
9.12 B.Sc: Bachelor of Science
9.13 M.Sc: Master of Science
9.14 B.E: Bachelor of Engineering
9.15 D.M.E: Diploma in Mechanical Engineering
9.16 D.E.E: Diploma in Electrical Engineering
9.17 I.T.I: Industrial Training Institute
9.18 H.S.C: Higher Secondary Certificate
9.19 S.S.L.C: Secondary School Leaving Certificate
To provide a standard procedure for Recruitment Policy.
2.0 SCOPE:
This procedure is applicable for the recruitment, selection and placement of an employee
in XXXXX company
3.0 RESPONSIBILITY:
HR Manager (Corporate office)
HR Executive
4.0 ACCOUNTABILITY:
Plant Manager
GM Quality Assurance
5.0 DEFINITIONS:
Nil
6.0 PROCEDURE:
6.1 In order to have right person for the right job, selection procedures have been defined.
6.2 For Pharmaceutical Industry the following departments have been identified.
a) Human Resources
b) Stores
c) Manufacturing
d) Packaging
e) Quality Control
f) Quality Assurance
g) Regulatory Affairs
i) Maintenance
j) House Keeping
6.3 In order to elaborate and explain the responsibilities of each department head and their subordinates and to cover all functions and authorities the following is the organization chart adopted with required Qualification, Experience and number of positions in each department.
6.4 GM QUALITY ASSURANCE
QUALIFICATION REQUIRED: B.Pharm / B.Sc (Chemistry) / M.Pharm / M.Sc
(Chemistry) from a reputed University.
EXPERIENCE: Minimum 10 years of experience in a QA and QC department in reputed Pharma industries. Excellent communication /expression and co- ordination skills to lead a team of managers and executives to achieve the desired results. To propose, suggest and to improve the Quality of the product and other techniques as per the expectation of management.
RESPONSIBILITIES:
. Shall be overall in charge of QA, QC and Regulatory Affairs and shall report to CEO.
· Shall organize plant control and coordinate all the functional areas of the plant.
· Shall review QA,QC and RAD functions regularly and take necessary steps for improving the quality of the products, techniques and the implementations of cGMP for effective quality management.
· Shall coordinate with Plant Manager, Manager QA, Manager QC and Regulatory Affairs for obtaining the manufacturing licences and necessary certificates for our formulations and renewal of licences from the Drug Control Authority.
Is responsible for improving and strengthening the quality system and documentation requirements and for cGMP.
· Shall coordinate with corporate office and other manufacturing units of the organization regarding technical matters related to products, processes and other technical issues.
6.5 PLANT MANAGER:
QUALIFICATION REQUIRED : B.Pharm / M.Pharm from a reputed University.
EXPERIENCE: Minimum 10 years of Practical experience in a Production department in a reputed Pharmaceutical Industries. Excellent Communications/Expression and Co-ordination skills – to lead a team of Managers and executives to achieve
the desired results. To propose, suggest and to improve the Production, Excellent leader ship qualities and other techniques as per the expectation of management.
DUTIES AND RESPONSIBILITIES:
Plant manager is the Overall in-charge of the Plant activities which include planning, organization, Direction and control of the activities of the industry and to lead the team.
Shall report to the Managing Director and shall control the team members, which includes Departmental Managers, executives and Operators.
To plan for the Raw Materials & Packing Materials for the products to be manufactured.
Co-ordination of the activities of all the departments for smooth functioning.
Plant Manager is responsible for improvement of the Production activities, development of new product, verification & modification of the existing Production activities.
Is responsible for maintenance of records & register and submission of any periodical return to the regulatory authorities, wherever required.
To direct the H.R.D. for Manpower planning.
To initiate training to executives and also encourage basic training for workmen by executives involved in respective departments.
6.6 EXECUTIVE HUMAN RESOURCES:
QUALIFICATION REQUIRED: Any Bachelor Degree
EXPERIENCE : 6 months experience in any Industrial undertakings, in the field of
Human Resources Management.
Others : Well versed in English and local language.
DUTIES AND RESPONSIBILITIES:
Shall report to Plant Manager.
Shall co-ordinate with HR Manager at Corporate office regarding all HR activities at the site.
Shall maintain Time Office Management.
Shall maintain Personnel files.
Shall monitor Security and House keeping activities.
Shall update all statutory records and registers as per factories act.
Shall update Muster Roll register and leave with wage register.
Shall responsible for statutory compliances and returns to Labour department/Inspector of factories and other Government departments as when required.
6.7 ASSISTANT MANAGER STORES:
QUALIFICATION REQUIRED: Any degree with Diploma in Materials
Management
EXPERIENCE: Minimum two years experience in any industry, preferably in
Pharma industry, good knowledge of English and Local language.
DUTIES AND RESPONSIBILITIES:
Assistant Manager Stores shall report to Plant Manger and is overall in charge of the stores.
To monitor and execute the stores operations and report to Plant Manager.
Shall procure Raw materials and Packing materials from Head office and prepare relative documents.
Shall control receipt and issue of Raw materials and Packing materials.
Shall ensure the daily activities are updated in respective records.
Shall prepare monthly stock statements of Raw materials and Packing materials.
Shall ensure Good manufacturing Practice during receipt and issue of Raw materials and packing materials.
Shall provide on job training as per SOP’s to stores personnel.
6.8 OFFICER STORES:
QUALIFICATION REQUIRED: H.S.C. / Any Degree
EXPERIENCE: 1 year in Stores department in any industry, Good knowledge of
English & Local language.
DUTIES AND RESPONSIBILITIES:
Officer Stores reports duty to Assistant Manager Stores.
To check the condition of the vehicle and receive the goods as per Standard Operating Procedure.
Shall prepare relative documents and updation for receiving goods.
Shall arrange the Raw/Packing Materials such a manner and batch wise with status of materials.
Shall receive the requisition from manufacturing/packing department and dispense the required quantities as per mentioned in the requisition.
Shall train the stores personnel and implementation the new systems as per cGMP.
Shall monitor and execute the daily activity as per Standard Operating Procedure and report to Assistant Manager Stores.
Responsible for all activities in the department in absence of Asst.Manager Stores.
6.9 HELPERS STORES:
QUALIFICATION REQUIRED : S.S.L.C.
EXPERIENCE : Fresh
OTHERS : Minimum Knowledge of Local language and English read & write.
DUTIES AND RESPONSIBILITIES:
Helpers shall take instructions from the Stores officer/ Assistant Manager Stores
To assist the stores officer in all respects.
Also responsible to maintain cleanliness.
6.10 ASSISTANT MANAGER MANUFACTURING:
QUALIFICATION REQUIRED : B.Pharm/M.Pharm
EXPERIENCE : Minimum 5 years Experience in manufacturing department in
Pharma Industry.
OTHERS : An excellent communication skills and good grasp of local
language, fluency in English, well versed in Co-ordination of
activities – Commanding knowledge and control.
DUTIES AND RESPONSIBILITIES:
Overall in charge of manufacturing activities in the department, and shall report to Plant Manager.
Responsible for the use of international and national standard codes available and applicable to the manufacturing activities.
Responsible for identification and verification, regarding process of the products in consultation with Plant Manger.
Responsible for development of any new product in consultation with Plant Manager/ Manager QC.
Responsible for implementing the cGMP in manufacturing area strictly.
Responsible for all the documents to be maintained in manufacturing department and to report to the Plant Manager.
Shall co-operate with HRD Department for organizing the trainings program for department operators and helpers accordingly.
Responsible for adherence to SOP. and ensure that same are implemented by all the staff members & employees in the department.
Responsible for sanctioning leave and maintaining discipline in the department.
In the absence of Plant Manager, Assistant Manager Manufacturing shall be responsible for all the concerned activities.
6.11 SENIOR EXECUTIVES MANUFACTURING:
QUALIFICATION REQUIRED: B.Pharm / M.Pharm
EXPERIENCE : Minimum 2 years Experience in manufacturing department in reputed Pharma Industry.
OTHERS : Good knowledge of English, Tamil preferable.
DUTIES AND RESPONSIBILITIES:
Responsible for the day to day planning of the products manufactured in the department in consultation with the Assistant Manager Manufacturing.
Responsible for allocating the work to operators and Co-ordination of the activities.
Responsible for maintaining discipline in the manufacturing area among the operators and helpers working.
To assist the Assistant Manager Manufacturing in all respects.
Responsible for any defects found while manufacturing the product and report to Assistant Manager Manufacturing and assist in rectifying the same.
Responsible for implementing the cGMP’s in consultation with Assistant Manager Manufacturing.
Shall co-operate with HRD Department through Assistant Manager Manufacturing in organizing the training programme for manufacturing department employees.
Is also responsible for all documentation of the department with the consultation of Assistant Manager Manufacturing .
Responsible for planning the shift schedule in consultation with Assistant Manager Manufacturing /Plant Manager.
6.12 JUNIOR EXECUTIVE MANUFACTURING:
QUALIFICATION REQUIRED: B.Pharm /M.Pharm
EXPERIENCE: : Fresh
OTHERS : Good knowledge of English, Tamil preferable.
DUTIES AND RESPONSIBILITIES:
Shall report to Assistant Manager Manufacturing and take instruction from him in respect of day to day production schedule.
Responsible to check for days attendance of workmen and allocate the work.
Responsible to effect any change in production schedule i.e. change in product/Changeover from one product to another with the consultation of senior executives Manufacturing.
Responsible for achieving the production target.
Responsible to solve any operators or helper’s problem with respect to production and if it is beyond his scope of any decision taking, then to take up the matter with executives Manufacturing or Assistant Manager Manufacturing in writing.
Responsible for arranging the raw materials required for the day’s production and arrange for dispensing activity and inform the stores personnel accordingly.
Responsible for allotting work on day to day basis to the staff members, skilled and unskilled workmen and supervise the work of department.
Responsible for labeling of the stage/status of the manufacturing process and labelling of the products.
Shall be responsible for all the concerned activities in the absence of executives Manufacturing.
6.13 OPERATOR MANUFACTURING:
QUALIFICATION REQUIRED: H.S.C. / S.S.L.C.
EXPERIENCE : Fresh
OTHERS : Minimum Knowledge of Local language and English to read &
write.
DUTIES AND RESPONSIBILITIES:
Operators are to take the instructions from shift Executive Manufacturing with regard to day’s manufacturing activities and shall execute the same.
Shall know about the execution of the different stages of manufacturing programmes. If not, they shall learn from Manager/Executive through training programmes.
Shall inform the Executive Manufacturing if any problem in the manufacturing and immediately stop the machine, if necessary.
Responsible for keeping the department and area clean with the help of helpers manufacturing and maintain hygienic condition during the manufacturing and also after manufacturing.
· Responsible for the correct labeling of the product and the process or stage of the manufacturing process.
6.14 HELPERS MANUFACTURING:
QUALIFICATION REQUIRED : S.S.L.C.
EXPERIENCE : Fresh
OTHERS : Minimum Knowledge of Local language and to read & write English
DUTIES AND RESPONSIBILITIES:
Helpers shall take instructions from the Operators/ Executives Manufacturing.
To assist the operators in all respects.
Also responsible to maintain cleanliness.
6.15 MANAGER PACKAGING:
QUALIFICATION REQUIRED: B.Pharm / B.Sc.,
EXPERIENCE : Minimum 3 years experience in packing department in reputed
Pharma industry.
OTHERS : With good communication skills, Good knowledge of English and
local languages. Good expression and command and control
over the staff members & workmen.
DUTIES AND RESPONSIBILITIES:
Overall in charge of Packaging activities in the department, and shall report to Plant Manager.
Responsible for the day to day activities in the strip ,Blister ,Tropical ,Alu-Alu and bulk packing .
To receive the instructions from the Manufacturing department with regards to the product which are manufactured and which are ready for packing.
Responsible to arrange the packing as per the schedule (or) as per the specific instructions.
Responsible to give proper instruction to the department supervisor and Co-ordinate the activities and Co-ordinate with HRD department for organizing Training Programmes.
Responsible to complete the packing of respective batches as per the schedule for the day.
Responsible to maintain the necessary records and co-ordinate with QA/QC department for getting the approval and necessary line clearance for further batches including the packing materials approval.
Responsible to arrange and get the approval packing materials from the stores.
Responsible for investigation in case of any defects in packing.
Responsible for maintaining discipline in the department and resolve the day to day problems if any.
Overall responsible for the Departmental SOP. and its adherence to Periodical improvement of the same.
6.16
SUPERVISOR PACKAGING:
QUALIFICATION REQUIRED: D.Pharm / B.Pharm / Any Degree.
EXPERIENCE :: Minimum 1 year in any industry with exposure to Packing
department.
OTHERS : With good communication skills and good knowledge of English
and the local languages.
DUTIES AND RESPONSIBILITIES:
Supervisor shall take instructions from Manager Packaging and discharge the duties accordingly.
Shall arrange the work for packing operators in different packing area and arrange the packing materials accordingly including the required tablets / capsules based on the packing schedule.
Responsible for maintaining the quality of finished products, and report any defects or problems to the manager Packaging.
Responsible for completing the batches to be packed within the prescribed time schedule.
Responsible to assist the Manager in maintaining the necessary records & registers of the department.
Responsible to get the necessary documents from assistants to co-ordinate with QC and QA Personnel.
Responsible for all activities in the packing department in the absence of Manager.
6.17 OPERATOR PACKAGING:
QUALIFICATION REQUIRED: S.S.L.C.
EXPERIENCE: Fresh
OTHERS : Good knowledge in local language and Should read and write
English.
DUTIES AND RESPONSIBILITIES:
Operator shall take instructions from Supervisor Packaging and discharge the duties accordingly.
To strictly follow the good practice of cleanliness, health and hygiene.
Responsible to keep the work place clean and dust free.
Shall reject the on-line defected Tablets/Capsules/packing materials and inform the same to the Supervisor.
Shall keep the record of weight of bulk tablets received from manufacturing department.
To give foil , PVC, Alu Alu consumption of each batch , reconciliation to be verified.
6.18 MANAGER QUALITY CONTROL:
QUALIFICATION REQUIRED: M.Pharm / B.Pharm / M.Sc./B.Sc.,
EXPERIENCE: Minimum 5 years in Quality Control Department in any reputed
Pharma industry
DUTIES AND RESPONSIBILITIES:
The Manager is overall in charge of the QC activities and shall co-ordinate the activities of all the functional areas in the department. He shall report duty to the GM - QA and organise plant control and co-ordinate the activities of the department.
The Manager has the authority to approve or reject the Raw Materials, Packing materials , intermediates and finished products based on analytical results and has the responsibility to control the non-conforming products.
Responsible for co-coordinating to obtain manufacturing licence for any formulation and renewal of licence with Plant Manager and RAD Manager from the drug control authority.
Responsible for the procurement, maintenance and shall implement necessary National/International Standard and codes.
Shall be responsible for identification, initiating action and verification of effective of corrective action regarding Process/Product in co-ordination with the Assistant Manager Manufacturing.
Responsible for implementation, improvement and modification of analytical techniques for the existing products.
Responsible for developing the analytical procedure for new Products.
Responsible for the stability studies for commercial packs of Marketed products.
Responsible to study the stability of developed products in the package proposal.
Responsible for implementation of Standard Operating Procedures.
Responsible for implementation of training programme in Co-ordination with Plant Manager , HRD Manager and QA Manager.
Responsible for the clearance and destruction of the rejected Raw Materials and Packing Materials.
6.19 ASSISTANT MANAGER QUALITY CONTROL:
QUALIFICATION REQUIRED : M.Pharm/B.Pharm/M.Sc (Chemistry) /
B.Sc(Chemsitry).,
EXPERIENCE : Minimum 5 years in Quality Control Department in any reputed
Pharma Organisation.
DUTIES AND RESPONSIBILITIES :
The Asst.Manager shall report duty to the Manager QC and is responsible for co-ordinating with other departments as well as planning the day to day activities in the department in co-ordination with executives.
To assist the Manager QC in all respects and has to take instruction from him.
Responsible for reviewing of Primary Standards and Working Standards, and modify the same.
Responsible to check the maintenance of the department premises and equipments, in view of cleanliness and good hygiene.
Responsible for reviewing of all Raw Materials, Packing Materials and Finished Products Specification and standard Operating Procedure in co-ordination with Manager QC.
Responsible for all validation works.
To assist Manager QC for developing the analytical methods for new products.
Shall be responsible for all the activities in QC department in the absence of QC Manager.
6.20 SENIOR EXECUTIVE QUALITY CONTROL:
QUALIFICATION REQUIRED : M.Pharm /B.Pharm / M.Sc (Chemistry) /
B.Sc(Chemsitry).,
EXPERIENCE : Minimum 3 years in Quality control Department in any reputed
Pharma Industry.
DUTIES AND RESPONSIBILITIES:
Senior QC Executive shall report duty to Assistant Manager QC and is responsible to assist Asst. Manager in all respects in the QC Department.
Responsible to assist Asst.Manager in validation work.
Responsible for calibration of equipments in the laboratory.
Responsible for all functions in QC Department in the absence of Asst. Manager.
6.21 JUNIOR EXECUTIVE QUALITY CONTROL:
QUALIFICATION REQUIRED : B.Pharm / M.Pharm / B.Sc.,/ M.Sc.,
EXPERIENCE : Minimum 6 months in Quality control Department in any reputed
Pharma Industry.
DUTIES AND RESPONSIBILITIES:
Junior QC Executive shall report duty to Assistant Manager QC and is responsible to assist Asst. Manager in all respects in the QC Department.
Responsible for sampling of Raw materials and Packing materials.
Responsible for analysis of Raw materials, Packing materials, intermediates, finished products and stability samples.
Responsible for preparation and storage of volumetric solutions, reagents and indicators.
Responsible for all activities in department in the absence of senior QC executive.
6.22 MICROBIOLOGIST :
QUALIFICATION REQUIRED : B.Sc./ M.Sc., (Microbiology)
EXPERIENCE : Minimum 2 years in Microbiological Laboratory in any
Pharma Industry.
DUTIES AND RESPONSIBILITIES:
Microbiologist shall report to Assistant Manager QC.
Responsible for all Microbiological analysis of Raw Materials, Finished Products, Water Analysis, Fumigation works and Packing materials.
Responsible for all the cleaning validation and environmental control activities.
Responsible for reviewing all documents regarding microbiology.
Shall co-ordinate with concerned department while fumigation is done in the factory.
6.23 MANAGER QUALITY ASSURANCE :
QUALIFICATION REQUIRED : M.Pharm /B.Pharm/ M.Sc (Chemistry) /
B.Sc (Chemsitry).,
EXPERIENCE : Minimum 5 years in Quality Assurance /Quality Control
Department in any reputed Pharma industry.
DUTIES AND RESPONSIBILITIES:
The Manager is overall incharge of the QA activities and shall co-ordinate the activities of all the functional areas in the department. He shall report duty to the GM Quality Assurance
To maintain and control an overall Quality Management System documentation.
Responsible for planning, co-ordination and implementing internal audit/vendor audit/Quality training programme.
To review and approve the Batch Manufacturing Record and Batch Packaging Record.
Responsible for investigation of Market complaints.
To review and approve the Qualification and validation documents.
Responsible for Batch release.
To initiate action to solve non conformance.
To organise review meeting and document their actions and corrective measures implemented for GMP requirements.
Responsible for implementation of GMP requirements.
He is nominated by management as GMP administrator.
6.24 ASSISTANT MANAGER QUALITY ASSURNCE :
QUALIFICATION REQUIRED : M.Pharm/B.Pharm/M.Sc (Chemistry) /
B.Sc(Chemsitry).,
EXPERIENCE : Minimum 5 years in Quality Assurance /Quality control Department in any reputed Pharma industry.
DUTIES AND RESPONSIBILITIES:
The Asst.Manager shall report duty to the QA Manager and is responsible for co-ordinating with other departments as well as planning the day to day activities in the department in co-ordination with executives.
Responsible for Document control cell, review of documents, draft circulation and finalization to prepare master documents.
To co ordinate for validation activities, compile necessary records for the same.
Responsible for all QA activities in absence of Manager QA.
To monitor the IPQA activities, review and report to the Manager.QA
6.25 SENIOR EXECUTIVE QUALITY ASSURANCE:
QUALIFICATION REQUIRED : M.Pharm/B.Pharm/M.Sc (Chemistry) /
B.Sc (Chemsitry).
EXPERIENCE : Minimum 3 years experience in Quality Assurance /Quality
Control Department in any reputed Pharma industry.
DUTIES AND RESPONSIBILITIES:
Senior Executive QA shall report duty to Assistant Manager QA.
Responsible for co-ordinating with production, QC and Maintenance for carrying out validation studies and equipment qualification.
Responsible to prepare Drug Master File (DMF).
Responsible for issuing Batch Manufacturing Record and Batch Packaging Record.
Responsible for monitoring the records of IPQA activities.
To monitor the compliance of standard operating procedure.
6.26 JUNIOR EXECUTIVE QUALITY ASSURANCE :
QUALIFICATION REQUIRED : M.Pharm/B.Pharm/M.Sc (Chemistry) /
B.Sc (Chemsitry).,
EXPERIENCE : Minimum 6 months experience in Quality Assurance /Quality
Control Department in any reputed Pharma industry.
DUTIES AND RESPONSIBILITIES:
Junior QA executive shall report duty to Assistant QA Manager.
Responsible for co-ordinating with QC and manufacturing for carrying out validation studies and equipment qualification.
Responsible for all IPQA activities.
Responsible for Line clearance in Stores , Manufacturing and Packing line , In process sampling and intermediate release activities .
To monitor the compliance of standard operating procedure.
6.27 MANAGER REGULATORY AFFAIRS:
QUALIFICATION REQUIRED : M.Pharm/B.Pharm/M.Sc (Chemistry) /
B.Sc (Chemsitry).,
EXPERIENCE : Minimum 5 years in Regulatory Affairs department in any reputed Pharma industry.
DUTIES AND RESPONSIBILITIES:
· The Manager RAD is overall in charge of the Regulatory activities and shall co-ordinate the activities of all the functional areas in the department. He shall report duty to the GM QA.
· Responsible for preparation of Technical Dossiers as per guidelines of importing countries .
· To co- ordinate with Production, QC, QA and provide samples for Tender and Registration purpose.
· Apply and obtain certificates and permission required from Drug control department like No Objection Certificate.
· Coordinating with Quality Control and apply for additional endorsement and to ensure the availability of endorsements in the manufacturing licences.
· Replying to Queries related to Reg
· istration as per requirements of importing countries.
· Obtaining attestation from embassies of various countries .
· Apply and obtain Certificate Of Pharmaceutical Product & Free Sale Certificate from Drug Control, Tamil Nadu.
· Label and Artwork verification on regulatory requirements.
6.28 EXECUTIVE REGULATORY AFFAIRS :
QUALIFICATION REQUIRED : M.Pharm/B.Pharm/M.Sc./B.Sc.,
EXPERIENCE : Minimum 6 months experience in Regualtory affairs Department
In any reputed Pharma industry.
DUTIES AND RESPONSIBILITIES:
The Executive Regulatory affairs shall report duty to the Manager RAD and is responsible for co-ordinating with other departments .
To assist Manager RAD for the preparation of Technical Dossiers as per guidelines of importing countries.
To co- ordinate with Production, QC, QA and provide samples for Tender and Registration purpose.
Apply and obtain certificates and permission required from Drug control department like No Objection Certificate.
Coordinating with Quality Control and apply for additional endorsement and to ensure the availability of endorsements in the manufacturing licences.
Apply and obtain Certificate Of Pharmaceutical Product & Free Sale Certificate from Drug Control, Tamil Nadu.
Label and Artwork verification on regulatory requirements.
6.29 ASSISTANT MANAGER MAINTENANCE :
QUALIFICATION REQUIRED : B.E./ D.M.E. / D.E.E..
EXPERIENCE : Minimum 5 years of experience in Maintenance department in
reputed Pharma Industry.
DUTIES AND RESPONSIBILITIES:
Assistance Manager Maintenance shall report duty to Plant Manager.
To assist the Assistant Manager Manufacturing/Plant Manager in all the maintenance work.
To help Plant Manager in the day to day work of factory premises.
To help Plant Manager to conduct/organize the training program as and when required.
To co-ordinate project/renovation work in the factory.
To plan all Preventive Maintenance and break down maintenance activities.
Responsible for procuring the Machinery spare parts for equipments.
Responsible to prepare Qualification and validation of all equipments and maintain relevant documents and records.
6.30 MAINTENANCE ENGINEER:
QUALIFICATION REQUIRED : B.E./D.M.E. / D.E.E..
EXPERIENCE: Minimum 2 years of experience in Maintenance Department in
reputed Pharma Industry.
DUTIES AND RESPONSIBILITIES:
Engineer Maintenance has to report duty to Assistant Manager maintenance.
Responsible for co-coordinating with production, QC and QA for carrying out validation studies and equipment qualification.
To attend all Preventive Maintenance and break down maintenance activities.
To maintain the machinery spare parts for equipments.
6.31 MAINTENANCE TECHNICIAN:
QUALIFICATION REQUIRED : I.T.I. (Mechanical/Electrical)
EXPERIENCE :: Minimum 6 months of experience in Maintenance department in
Pharma Industry.
DUTIES AND RESPONSIBILITIES :
Maintenance Technician has to report duty to Assistant Manager maintenance.
Maintenance Technician has to assist the maintenance engineer in day to day work.
Shall know how to execute the different stages of Maintenance activities. If not, they shall learn from Maintenance engineer through training programmes.
To inform Maintenance engineer in regard to any breakdown of machine or any other machinery problems and to take necessary action in this regards for proper rectification.
To maintain all utility equipments, air compressor, generator & electrical work etc.,
6.32 SUPERVISOR HOUSE KEEPING:
QUALIFICATION REQUIRED : HSC / Any Degree.
EXPERIENCE : 1 – 2 years of experience in relevant field.
DUTIES AND RESPONSIBILITIES:
House keeping supervisor shall report to Plant Manager and he shall co-ordinate with HR Department & Maintenance Department for House keeping activities.
Overall in charge of all the good house keeping activities of the plant.
Shall be responsible to cover house keeping of external, peripheral and internal production areas.
Shall comply house keeping standards on par with good manufacturing practice.
Shall be responsible for Pest & Rodent control activities.
Shall give proper training regarding sanitation to the personnel involved in cleaning.
Shall maintain House keeping records.
7.0 REFERENCES:
Nil
8.0 ENCLOSURES:
Nil
9.0 ABBREVIATIONS:
9.1 CEO: Chief Executive Officer
9.2 RAD: Regulatory Affairs Department
9.3 GM: General Manager
9.4 QA: Quality Assurance
9.5 IPQA: In process Quality Assurance
9.6 QC: Quality Control
9.7 HRD: Human Resources Department
9.8 SOP: Standard Operating Procedure
9.9 B.Pharm: Bachelor of Pharmacy
9.10 M.Pharm: Master of Pharmacy
9.11 D.Pharm: Diploma in Pharmacy
9.12 B.Sc: Bachelor of Science
9.13 M.Sc: Master of Science
9.14 B.E: Bachelor of Engineering
9.15 D.M.E: Diploma in Mechanical Engineering
9.16 D.E.E: Diploma in Electrical Engineering
9.17 I.T.I: Industrial Training Institute
9.18 H.S.C: Higher Secondary Certificate
9.19 S.S.L.C: Secondary School Leaving Certificate
SOP - store procedures
SOP: Cleaning Procedure for Raw Material Stores Dispensing Equipments
Procedure
For every drug substance its dedicated equipments is used. On each piece of equipment name of the drug substance for which it is reserved has been engraved. Dispensing equipment's used for excepients is not dedicated. However, cleaning procedure for all the equipments is same. After completing the dispensing operation, the dispensing equipment is carefully wrapped in a polythene bag and placed in a plastic box, which has been labeled as “USED SCOOPS, SPATULAS FOR CLEANING”.
The Equipment is scrubbed with 2.0% TEEPOL solution and rinsed under running tap. To remove sticky substances, the equipments are rinsed with hot water and scrubbed with 2.0% TEEPOL solution after rinsing under running tap water. The equipment is rinsed with distilled water and allowed to drain. Then the equipment is sprayed with 70% IPA and dried with hand held drier. The cleaned and dried equipment is wrapped in aluminium foils and covered with kraft paper. Affix “CLEAN & READY FOR USE” label.
SOP: Operating Procedure for Raw Material Dispensing
Procedure :
Before commencement of any weighing the balance should be checked for its “0” position and there should be no dust on the platform, weighing bowl, dial or beam. Dust extraction system and positive pressure modules should be “ON” and doors should be closed. When materials are weighed, Name of the Material, Tare Weight, Gross Weight and Nett Weight of the material being dispensed should be noted for each item and should be recorded. When two lot numbers are used to makeup the required quantity, quantity of each lot should be recorded. The material should be dispensed clearly labelled with Name of the Material, Batch No, QC Control No, Name of the Product (for which it is dispensed) the Nett Weight, Gross Weight. Upon the receipt of dispensed raw material labeling and indicated weight should be checked. All the container should be weighed individually and gross weight should be cross checked. The weighing tag should be signed by three individuals by the dispensing person (1); Production Supervisor / chemist (2); Stores incharge / supervisor (3).
For formulations all the weights are cross checked with master formula card with their corresponding batch size.
For new products the following persons should cross check weight of all the ingredients.
1. Weighing Person
2. Production chemist / supervisor
3. Store supervisor / manager
4. Production manager
5. QC manager
6. Factory manager
7. Director / Works
SOP : Cleaning Schedule for Quarantine Raw Material Stores
1. WALLS AND WINDOWS :
Wipe the entire walls and glass windows with clean towel every day.
2. FLOORS :
Clean the entire floor using vacuum cleaner every day, and the dispensing area immediately after every weighing.
3. WEIGHING ASSESORIES :
1. Clean the weighing stones once every day.
2. Clean the balance every day without disturbing its position and every time between weighing of different raw – materials.
3. Wash the utensils and dry the same between weighings of different raw materials.
4. FURNITURES :
Clean it with towel and vacuum cleaner.
SOP : Operation Procedure for Quarantine Maintenance
Procedure :
As soon as the material arrived into the quarantine the following points are to be checked.
1. Check if the supplier Name is in the approved vendor list.
2. Check the condition of the packing, Mfg Date, Exp Date.
3. Check the weight / units of the consignment.
4. Check the purchases order No and the ordered qty and the required date with the DC.
5. Place the material in a proper position and it should be easily identifiable.
6. Affix “UNDER TEST” label on each container or pack.
7. Under test slip should have the following details :
Name of the Material, B.No, Mfg Dt, Exp Dt, Name of the Manufacturer, Name of the Supplier, Qty Received, Gross Wt, Nett Wt, Chellan No / D.C. No, Date.
8. Record the receipt in the Stores Ledger.
Precaution : Follow the same procedure for old materials which is sent for re-analysis.
All the materials should have Name of the Material, Initial analysis date, and percentage of purity, B.No, Mfg Dt, Exp Dt, Name of the Manufacturer, Name of the Supplier, Qty Received, Gross Wt, Net Wt, Chellan No / D.C. No, Date. And the label should state that “For Medicinal Use Only” And It Should Not Have “Not For Medical Use” “For Animal Use Only” “Not For Human Use” …. like that.
Procedure
For every drug substance its dedicated equipments is used. On each piece of equipment name of the drug substance for which it is reserved has been engraved. Dispensing equipment's used for excepients is not dedicated. However, cleaning procedure for all the equipments is same. After completing the dispensing operation, the dispensing equipment is carefully wrapped in a polythene bag and placed in a plastic box, which has been labeled as “USED SCOOPS, SPATULAS FOR CLEANING”.
The Equipment is scrubbed with 2.0% TEEPOL solution and rinsed under running tap. To remove sticky substances, the equipments are rinsed with hot water and scrubbed with 2.0% TEEPOL solution after rinsing under running tap water. The equipment is rinsed with distilled water and allowed to drain. Then the equipment is sprayed with 70% IPA and dried with hand held drier. The cleaned and dried equipment is wrapped in aluminium foils and covered with kraft paper. Affix “CLEAN & READY FOR USE” label.
SOP: Operating Procedure for Raw Material Dispensing
Procedure :
Before commencement of any weighing the balance should be checked for its “0” position and there should be no dust on the platform, weighing bowl, dial or beam. Dust extraction system and positive pressure modules should be “ON” and doors should be closed. When materials are weighed, Name of the Material, Tare Weight, Gross Weight and Nett Weight of the material being dispensed should be noted for each item and should be recorded. When two lot numbers are used to makeup the required quantity, quantity of each lot should be recorded. The material should be dispensed clearly labelled with Name of the Material, Batch No, QC Control No, Name of the Product (for which it is dispensed) the Nett Weight, Gross Weight. Upon the receipt of dispensed raw material labeling and indicated weight should be checked. All the container should be weighed individually and gross weight should be cross checked. The weighing tag should be signed by three individuals by the dispensing person (1); Production Supervisor / chemist (2); Stores incharge / supervisor (3).
For formulations all the weights are cross checked with master formula card with their corresponding batch size.
For new products the following persons should cross check weight of all the ingredients.
1. Weighing Person
2. Production chemist / supervisor
3. Store supervisor / manager
4. Production manager
5. QC manager
6. Factory manager
7. Director / Works
SOP : Cleaning Schedule for Quarantine Raw Material Stores
1. WALLS AND WINDOWS :
Wipe the entire walls and glass windows with clean towel every day.
2. FLOORS :
Clean the entire floor using vacuum cleaner every day, and the dispensing area immediately after every weighing.
3. WEIGHING ASSESORIES :
1. Clean the weighing stones once every day.
2. Clean the balance every day without disturbing its position and every time between weighing of different raw – materials.
3. Wash the utensils and dry the same between weighings of different raw materials.
4. FURNITURES :
Clean it with towel and vacuum cleaner.
SOP : Operation Procedure for Quarantine Maintenance
Procedure :
As soon as the material arrived into the quarantine the following points are to be checked.
1. Check if the supplier Name is in the approved vendor list.
2. Check the condition of the packing, Mfg Date, Exp Date.
3. Check the weight / units of the consignment.
4. Check the purchases order No and the ordered qty and the required date with the DC.
5. Place the material in a proper position and it should be easily identifiable.
6. Affix “UNDER TEST” label on each container or pack.
7. Under test slip should have the following details :
Name of the Material, B.No, Mfg Dt, Exp Dt, Name of the Manufacturer, Name of the Supplier, Qty Received, Gross Wt, Nett Wt, Chellan No / D.C. No, Date.
8. Record the receipt in the Stores Ledger.
Precaution : Follow the same procedure for old materials which is sent for re-analysis.
All the materials should have Name of the Material, Initial analysis date, and percentage of purity, B.No, Mfg Dt, Exp Dt, Name of the Manufacturer, Name of the Supplier, Qty Received, Gross Wt, Net Wt, Chellan No / D.C. No, Date. And the label should state that “For Medicinal Use Only” And It Should Not Have “Not For Medical Use” “For Animal Use Only” “Not For Human Use” …. like that.
SOP: General for Pharma Plant
SOP: Cleaning Procedure for Open Space
Procedure
1. Walls and Windows :
Wipe the entire halls and glass windows with soap solution followed by dry lint free cloth.
2. Floor : Morning :
Clean the entire floor using soap water, subsequently spray the floor with diluted phenyl and wipe it once again.
3. Evening:
Clean the entire floor using soap water, subsequently spray the floor with diluted phenyl and wipe it once again.
SOP : Cleaning Schedule for General Space
1. WALLS AND WINDOWS:
Wipe the entire walls and glass windows with clean towel every day.
2. FLOORS:
1. First cleaning in the morning: Clean the entire floor using soap water, subsequently spray the floor with diluted phenyl and wipe it once again.
2. Subsequent cleaning: Clean the entire floor using Soap water, once in every two hours.
{Note: Follow the same procedure with different cleaning agents like Dettol, savlon, IPA etc.,
SOP: CHANGE OF FACTORY UNIFORM & FOOT WARE
1. Employees before entering the factory premises should wear the factory uniform in the change rooms.
2. Employees before entering the door should remove their personal footwear and have to wear the foot ware provided by the company.
3. Employees should swab their hands using isopropyl alcohol spray kept near the entrance door, before entering the main block of the factory.
4. Employees while leaving the factory premises should leave the company foot wear in the designated area and have to wear their personal footwear.
5. Employees should wear cleaned foot-wear daily.
SOP: Cleaning Procedure for Raw Material Stores
Objective
In the process of receiving issuing and dispensing lot of dust is created which settles and contaminates the whole area around the dispensing table or the entire stores. This dust may be harmful if inhaled by the persons working around the area, also in all probability the dust settles in the neighboring containers / materials which may cause cross contamination. Therefore, it is necessary that utmost care be taken in cleaning the whole area around the dispensing table and the storage place.
Caution
Take only one item at a time for dispensing. Items scheduled for dispensing later are not to be kept along with the material being dispensed. Clean the surface of the container with a dry duster before it is taken on dispensing table.
Collect the powder spilled over and around the dispensing table with a duster in a dustbin. Wip the area and the balance with a dry cloth. Clean the dispensing area and the balance with a wet cloth repeating the action two or three times. Apply IPA 70% finally for wiping and cleaning the balance and dispensing table to avoid contamination.
Procedure
For Daily Cleaning:
Collect the dust settled over tables, floors, containers etc., by using vacuum cleaner.
Vacate the empty pallets / boxes / containers from the areas or from the racks and wipe the dust with a cotton cloth or duster.
Sweep the floor thoroughly. Use the wet mop for thorough cleaning of the floor use 1% TEEPOL or liquid soap followed by swabbing by fresh tap water.
For Weekly cleaning
Collect the dust settled over the office equipments from time to time, furnitures & fixtures and walls by using blower cum vacuum cleaner.
Wipe the dust with a dry duster. Sweep the floor thoroughly; use a wet mop for thorough cleaning of the floor. Use 1% TEEPOL or liquid soap followed by swabbing by fresh tap water.
For Once in Three – Months Cleaning
Vacate palletized materials from the stores. Collect the dust by using vacuum cleaner. The ceiling of the whole area of stores including racks shelves, walls cleaned with cloth duster. Sweep the floor, add 100 g caustic soda to 10 lits of tap water for cleaning the floor, mop the floor with this solution wipe the floor with 1% TEEPOL solution. Apply pest control insecticides around the stores, replace material in their designated location.
Additional Precaution
Ensure that all the received goods are in clean condition. If not arrange to get them cleaned before placing them in their designated locations. If goods are received in an unclean container isolate and transfer into clean containers ensuring appropriate labeling.
Procedure
1. Walls and Windows :
Wipe the entire halls and glass windows with soap solution followed by dry lint free cloth.
2. Floor : Morning :
Clean the entire floor using soap water, subsequently spray the floor with diluted phenyl and wipe it once again.
3. Evening:
Clean the entire floor using soap water, subsequently spray the floor with diluted phenyl and wipe it once again.
SOP : Cleaning Schedule for General Space
1. WALLS AND WINDOWS:
Wipe the entire walls and glass windows with clean towel every day.
2. FLOORS:
1. First cleaning in the morning: Clean the entire floor using soap water, subsequently spray the floor with diluted phenyl and wipe it once again.
2. Subsequent cleaning: Clean the entire floor using Soap water, once in every two hours.
{Note: Follow the same procedure with different cleaning agents like Dettol, savlon, IPA etc.,
SOP: CHANGE OF FACTORY UNIFORM & FOOT WARE
1. Employees before entering the factory premises should wear the factory uniform in the change rooms.
2. Employees before entering the door should remove their personal footwear and have to wear the foot ware provided by the company.
3. Employees should swab their hands using isopropyl alcohol spray kept near the entrance door, before entering the main block of the factory.
4. Employees while leaving the factory premises should leave the company foot wear in the designated area and have to wear their personal footwear.
5. Employees should wear cleaned foot-wear daily.
SOP: Cleaning Procedure for Raw Material Stores
Objective
In the process of receiving issuing and dispensing lot of dust is created which settles and contaminates the whole area around the dispensing table or the entire stores. This dust may be harmful if inhaled by the persons working around the area, also in all probability the dust settles in the neighboring containers / materials which may cause cross contamination. Therefore, it is necessary that utmost care be taken in cleaning the whole area around the dispensing table and the storage place.
Caution
Take only one item at a time for dispensing. Items scheduled for dispensing later are not to be kept along with the material being dispensed. Clean the surface of the container with a dry duster before it is taken on dispensing table.
Collect the powder spilled over and around the dispensing table with a duster in a dustbin. Wip the area and the balance with a dry cloth. Clean the dispensing area and the balance with a wet cloth repeating the action two or three times. Apply IPA 70% finally for wiping and cleaning the balance and dispensing table to avoid contamination.
Procedure
For Daily Cleaning:
Collect the dust settled over tables, floors, containers etc., by using vacuum cleaner.
Vacate the empty pallets / boxes / containers from the areas or from the racks and wipe the dust with a cotton cloth or duster.
Sweep the floor thoroughly. Use the wet mop for thorough cleaning of the floor use 1% TEEPOL or liquid soap followed by swabbing by fresh tap water.
For Weekly cleaning
Collect the dust settled over the office equipments from time to time, furnitures & fixtures and walls by using blower cum vacuum cleaner.
Wipe the dust with a dry duster. Sweep the floor thoroughly; use a wet mop for thorough cleaning of the floor. Use 1% TEEPOL or liquid soap followed by swabbing by fresh tap water.
For Once in Three – Months Cleaning
Vacate palletized materials from the stores. Collect the dust by using vacuum cleaner. The ceiling of the whole area of stores including racks shelves, walls cleaned with cloth duster. Sweep the floor, add 100 g caustic soda to 10 lits of tap water for cleaning the floor, mop the floor with this solution wipe the floor with 1% TEEPOL solution. Apply pest control insecticides around the stores, replace material in their designated location.
Additional Precaution
Ensure that all the received goods are in clean condition. If not arrange to get them cleaned before placing them in their designated locations. If goods are received in an unclean container isolate and transfer into clean containers ensuring appropriate labeling.
SOP FOR STANDARD OPERATING PROCEDURES
Precautions for Preparing SOP’s
Instructions and Procedures should be written in a clear language, specifically applicable to the facilities provided. Records are make in such a way that during manufacturing process, it will show that all the steps required by the defined procedures and instructions have in –fact been taken and that the quantity and quality of the product is as expected. Any significant expected deviation are fully recorded and investigated.
Procedures
Documents required are to be designed, prepared, received and distributed with such a care that it will comply with the relevant parts of the manufacturing and operating procedures as well as facilities available. Documents will be approved, signed and dated by appropriate authorised persons and person nominated by the management.
Persons Having Authority may include
i. Nominee of local staff, expert in his own field and familiar with Good Manufacturing Practices
ii. E.D (Operations)
iii. Manager Quality Control
iv. Manager Quality Assurance
v. E.D. (Technical)
1. Documents must not be changed, amended or added to without authorisation.
2. Documents should have the title, code number, superceded number, date of issue and effective date as well as the purpose should be clearly stated.
3. Documents should be laid out in an orderly fashion and be easy to check; critical steps should be highlighted.
4. Reproduced documents should be clear and legible. The reproduction of working documents from the master documents must not allow any error to be introduced throughout the reproduction process.
5. Documents should be regularly reviewed and kept up to date. When a document has been revised by the team, effective date of corrected version is given and previous suspended documents should be preserved for at least one year after the expiry date of the last batch made on it.
6. To prevent inadvertent use of the superceded version, dispose off the documents after the expiry period, in the presence of persons listed above. Till the time these are disposed off, they are kept separately under lock and key in the control of QC department.
7. Any alteration made to a document will be signed and dated by all the above persons who are authorised to do so. The alteration will permit the reading of the original information, where appropriate, the reason for the alteration will be recorded.
8. One original copy each of Master Formula Cards, Standard operating Procedures and specifications should be stored in lock, one copy should be retained with each member who signed that document and one copy is required to be kept at each concerned department. Whenever necessary, it should be displayed at respective area and retained by concerned person of production, technical supervisor, QA chemist and QC Chemists.
9. All the records should posses particular code numbers to identify it and should be easily accessible with respective department.
10. Reference number is given to each document and supporting document. For example, SOP in association with master formula card, is given the same sub-code, which refers to that master formula card only.
Validity : Till further amendment / revision
Instructions and Procedures should be written in a clear language, specifically applicable to the facilities provided. Records are make in such a way that during manufacturing process, it will show that all the steps required by the defined procedures and instructions have in –fact been taken and that the quantity and quality of the product is as expected. Any significant expected deviation are fully recorded and investigated.
Procedures
Documents required are to be designed, prepared, received and distributed with such a care that it will comply with the relevant parts of the manufacturing and operating procedures as well as facilities available. Documents will be approved, signed and dated by appropriate authorised persons and person nominated by the management.
Persons Having Authority may include
i. Nominee of local staff, expert in his own field and familiar with Good Manufacturing Practices
ii. E.D (Operations)
iii. Manager Quality Control
iv. Manager Quality Assurance
v. E.D. (Technical)
1. Documents must not be changed, amended or added to without authorisation.
2. Documents should have the title, code number, superceded number, date of issue and effective date as well as the purpose should be clearly stated.
3. Documents should be laid out in an orderly fashion and be easy to check; critical steps should be highlighted.
4. Reproduced documents should be clear and legible. The reproduction of working documents from the master documents must not allow any error to be introduced throughout the reproduction process.
5. Documents should be regularly reviewed and kept up to date. When a document has been revised by the team, effective date of corrected version is given and previous suspended documents should be preserved for at least one year after the expiry date of the last batch made on it.
6. To prevent inadvertent use of the superceded version, dispose off the documents after the expiry period, in the presence of persons listed above. Till the time these are disposed off, they are kept separately under lock and key in the control of QC department.
7. Any alteration made to a document will be signed and dated by all the above persons who are authorised to do so. The alteration will permit the reading of the original information, where appropriate, the reason for the alteration will be recorded.
8. One original copy each of Master Formula Cards, Standard operating Procedures and specifications should be stored in lock, one copy should be retained with each member who signed that document and one copy is required to be kept at each concerned department. Whenever necessary, it should be displayed at respective area and retained by concerned person of production, technical supervisor, QA chemist and QC Chemists.
9. All the records should posses particular code numbers to identify it and should be easily accessible with respective department.
10. Reference number is given to each document and supporting document. For example, SOP in association with master formula card, is given the same sub-code, which refers to that master formula card only.
Validity : Till further amendment / revision
Sunday, July 27, 2008
SOP - OPERATION AND CALIBRATION OF STANDARD ELECTRONIC BALANCE MODEL No: CP225D (MAKE: SARTORIUS)
1.0 Objective
To lay down a procedure for operation and calibration of CP225D analytical balance to give accurate and reproducible results.
2.0 SCOPE
This sop covers the operation and calibration procedure of analytical Balance and it is applicable to Quality control department.
3.0 Responsibility
Officer / Executive
4.0 Accountability
Department Head
5.0 Procedure
5.1 general cleaning PROCEDURE
5.1.1 Ensure that the power supply to the balance is switched ‘ OFF’ before cleaning
5.1.2 Clean the pan and inside of the balance with a brush.
5.1.3 Clean the outside of the balance with a clean dry cloth every day. occasionally wet cloth dipped in dilute soap solution maybe used .Precaution has to be taken to clean the balance immediately with dry cloth to remove the moisture.
5.2 Operating Instructions
5.2.1 Ensure that the balance is properly connected to power supply.
5.2.2 Check that the spirit level is in the center of the level or not and if necessary adjust the level by turning the leveling screws.
5.2.3 Switch on the main switch, this balance displays ‘±8,8,8,8,8,8,8,8,8,8,8,8’ followed by 0.00000 g (display unit is in gm)
5.3 WEIGHING PROCEDURE:
5.3.1 Place a clean butter paper on the pan, close the balance door and press at
“ TARE” position on the bar to tare the paper weight. The display should read 0.00000g.
5.3.2 With a clean spatula add required quantity of sample carefully on to the butter paper. Close the balance door.
5.3.3 Allow the balance to display ‘g’ along with the weight.
5.3.4 Carefully transfer the sample into the flask and place the butter paper again on the pan of the balance.
5.3.5 Record both initial and final readings.
5.4 PRECAUTIONS :
5.4.1 During the transferring of sample to the flask ensure that the neck of the flask, where the butter paper would be in contact is absolutely dry.
5.5 CALIBRATION
5.5.1 SELF CALIBRATION
5.5.1.1 Ensure that the power supply to the balance is switched ‘OFF’ before cleaning.
5.5.1.2 Clean the pan and inside of the balance with a brush.
5.5.1.3 Check that the spirit level is in the center of the level or not and if necessary adjust the level by turning the leveling screws and close the balance doors.
5.5.1.4 Switch on the balance and allow it to stabilize for 10 minutes.
5.5.1.5 Press the CAL button and display shows ‘C’ .After some times, the display shows as ‘CC’ and followed by 0.00000 g. which denotes the end of self calibration.
5.5.2 CALIBRATION AGAINST STANDARD WEIGHTS
5.5.2.1 Check the weight of the standard weights 100 mg, 200 mg, 500mg and 1g five times by keeping the weight on the ‘·’ positions on the Weight pan as shown in the figure.
To lay down a procedure for operation and calibration of CP225D analytical balance to give accurate and reproducible results.
2.0 SCOPE
This sop covers the operation and calibration procedure of analytical Balance and it is applicable to Quality control department.
3.0 Responsibility
Officer / Executive
4.0 Accountability
Department Head
5.0 Procedure
5.1 general cleaning PROCEDURE
5.1.1 Ensure that the power supply to the balance is switched ‘ OFF’ before cleaning
5.1.2 Clean the pan and inside of the balance with a brush.
5.1.3 Clean the outside of the balance with a clean dry cloth every day. occasionally wet cloth dipped in dilute soap solution maybe used .Precaution has to be taken to clean the balance immediately with dry cloth to remove the moisture.
5.2 Operating Instructions
5.2.1 Ensure that the balance is properly connected to power supply.
5.2.2 Check that the spirit level is in the center of the level or not and if necessary adjust the level by turning the leveling screws.
5.2.3 Switch on the main switch, this balance displays ‘±8,8,8,8,8,8,8,8,8,8,8,8’ followed by 0.00000 g (display unit is in gm)
5.3 WEIGHING PROCEDURE:
5.3.1 Place a clean butter paper on the pan, close the balance door and press at
“ TARE” position on the bar to tare the paper weight. The display should read 0.00000g.
5.3.2 With a clean spatula add required quantity of sample carefully on to the butter paper. Close the balance door.
5.3.3 Allow the balance to display ‘g’ along with the weight.
5.3.4 Carefully transfer the sample into the flask and place the butter paper again on the pan of the balance.
5.3.5 Record both initial and final readings.
5.4 PRECAUTIONS :
5.4.1 During the transferring of sample to the flask ensure that the neck of the flask, where the butter paper would be in contact is absolutely dry.
5.5 CALIBRATION
5.5.1 SELF CALIBRATION
5.5.1.1 Ensure that the power supply to the balance is switched ‘OFF’ before cleaning.
5.5.1.2 Clean the pan and inside of the balance with a brush.
5.5.1.3 Check that the spirit level is in the center of the level or not and if necessary adjust the level by turning the leveling screws and close the balance doors.
5.5.1.4 Switch on the balance and allow it to stabilize for 10 minutes.
5.5.1.5 Press the CAL button and display shows ‘C’ .After some times, the display shows as ‘CC’ and followed by 0.00000 g. which denotes the end of self calibration.
5.5.2 CALIBRATION AGAINST STANDARD WEIGHTS
5.5.2.1 Check the weight of the standard weights 100 mg, 200 mg, 500mg and 1g five times by keeping the weight on the ‘·’ positions on the Weight pan as shown in the figure.
5.1.1.1 Take 10 individual weights of 500 mg standard weight and note down the weights.5.1.1.2 Calculate the Standard Deviation of the 10 individual weights and calculate the measurement of uncertainty by using the following formula.
= Standard Deviation x 3 .
Standard weight of 500 mg
5.1.1.3 Standard weight of 500 mg should be taken from the calibration certificate supplied along the weight box.
5.1.1.4 ACCEPTANCE CRITERIA
Tolerance shall not exceed 0.1% of the weight
5.1.2 ACCEPTANCE CRITERIA
The uncertainty measurement should not be more than 0.001
5.1.3 Record all the observations in the calibration record as per annexure-1.
5.1.4 Affix a ‘CALIBRATED’ label on the instrument.
5.1.5 Report any discrepancy observed during calibration or operating the instrument to department Head and notify the defect to Service engineer to rectify the defect. Affix “BREAK DOWN” label on the instrument till it gets rectified.
5.7 Frequency of calibration
Once a month and after each maintenance job.
6.0 REASON FOR REVIEW:
First time issue.
SOP - OPERATION AND CALIBRATION PROCEDURE FOR INFRA RED SPECTROPHOTOMETER (MAKE: BUCK SCIENTIFIC)
1.0 OBJECTIVE
To ensure that the instrument performs satisfactorily and gives accurate and reproducible results.
2.0 SCOPE
This SOP covers operation and calibration procedure for Infra red spectrophotometer and this SOP is applicable to Quality control department.
3.0 RESPONSIBILITY
Officer / Executive.
4.0 ACCOUNTABILITY
Department Head
5.0 PROCEDURE
5.1 PROCEDURE FOR GENERAL CLEANING
5.1.1 Ensure that the power supply to the instrument is switched OFF before cleaning.
5.1.2 De-dust the instrument with a clean dry cloth every day.
5.1.3 Once in a week remove adhered dust by wet mopping using detergent solution.
Afterwards wipe the surface with a clean dry cloth to remove traces of detergent.
5.1.4 Caution to be taken to clean the oven immediately with dry cloth to remove the moisture.
5.2 PROCEDURE FOR OPERATION
5.2.1 Switch on the instrument and wait for 30 minutes for heating and stabilizing the lamp.
5.2.2 Then turn on P.C and the Printer.
5.2.3 Go to ‘Buck IR’ icon and double click, and Wait for software initialize with following Word Checking For attached instruments please wait……..
5.2.4 Click on ‘instrument ,’and also Click on ‘Adjust parameters’ and Give the Following parameters For Set up Options .
Optical Mode : Transmission
Scan time : 3
Gain setting : 0
Pen Responsive : 0.1
Scan type : Reference.
5.2.5 In case of Liquid cell, Change Optical Mode to Absorbance by keeping the rest of the parameters as such.
5.2.6 After Setting this, Instrument shows this parameters in its Screen.
5.2.7 5.2.7 Click Instrument and go to Communication parameters . Give Following parameters as a Communication parameters.
Communication Configuration
COM Port : COM1
Baud Port : 2400
Parity : none
Stop bits : 1
Data bits : 8
Click OK for Setting the above parameters in Instrument.
5.2.8 Click on ‘Instrument’ and Go to ‘Scan Sample’
This system Will assign Scan sample.
5.2.9 In Scan Sample, Give 4000 ,600 for start & end wave numbers respectively.
5.2.10 System will show Single beam energy profile and will beep during scan. This is considered as Blank Spectrum.(Air back ground spectrum)
5.3 PREPARATION SAMPLE PELLET:
5.3.1 Weigh about 400 mg of potassium bromide (IR spectroscopy grade, previously dried in-between 1200-1300 C ).
5.3.2 Transfer the weighed material to porcelain mortar & pestle.
5.3.3 Weigh accurately 4 mg of testing sample and transfer it to potassium bromide containing mortar.
5.3.4 Grind and mix well.
5.3.5 Weigh accurately 150 mg of mixed sample and transfer this to the pellet making accessory, using KBr press instrument as per SOP.No: BGQC009-00 pellet is
prepared.
5.4 SAMPLE MEASURMENT
5.4.1 Place the sample pellet, in pellet terminal and give the file name in Scan sample (procedure same as described in air spectrum) and Click OK.
5.4.2 System will show single beam energy profile and will give beep during scan. After scan processing, Go to Arithmetic function .Click Transmission, and select the Correct background(Air spectrum) file from file list . Click on OK. Software will generate the % of Scan for that Sample. This is considered as Sample spectrum.
5.4.3 Go to peak function, adjust peak-threshold and Click on View peaks.
5.4.4 Go to File, select File information and give the following parameters:
Memo : Name of sample analyzed
Method : KBR PELLETE
Instrument : BUCK IR
5.4.5 Click on OK. This is useful for future reference.
5.4.6 Go to View function, Select Overlaid Option for Comparison with Reference spectrum.
5.4.7 Go to File function, select print set-up& print for taking print-out of Scanned spectrum
5.4.8 Go to peak function select print peaks report for peaks report of scanned spectrum.
5.5 CALIBRATION
5.5.1 RESOLUTION
Record the spectrum of a polystyrene film 0.05 mm in thickness.
5.5.2 ACCEPTANCE CRETERIA
5.5.2.1 The depth of the trough from the maximum at about 2851 cm-1 and 2870cm-1 should be greater than 18 % transmittance
5.5.2.2 The depth of the trough from the maximum at about 1586 cm-1 and 1589cm-1 should be grater than 12% transmittance
5.5.3 WAVE NUMBER ACCURACY
5.5.3.1 Record the spectrum of a polystyrene film 0.05 mm in thickness.
5.5.4 ACCETANCE CRITERIA
5.5.4.1 It should give the maxima at the following wave numbers within the acceptable range.
S. No: 1.
WAVE NUMBER 2850.7
ACCEPTABLE RANGE 2846.7 ----- 2854.7
S. No: 2.
WAVE NUMBER 1601.4
ACCEPTABLE RANGE 1597.4 ----- 1605.7
S. No: 3.
WAVE NUMBER 906.7
ACCEPTABLE RANGE 902.7 ----- 1000.7
5.5.5 Record the results in the calibration record as per Annexure-1
5.5.6 Affix a ‘CALIBRATED’ label on the instrument.
5.6 Report any discrepancy observed during calibration or operating the instrument to Department Head and notify the defect to utility / service engineer to rectify the defect. Affix “BREAK DOWN” label on the instrument till it gets rectified.
5.7 FREQUENCY OF CALIBRATION
Once in three months and after each maintenance job.
6.0 REASON FOR REVIEW:
First time issue.
To ensure that the instrument performs satisfactorily and gives accurate and reproducible results.
2.0 SCOPE
This SOP covers operation and calibration procedure for Infra red spectrophotometer and this SOP is applicable to Quality control department.
3.0 RESPONSIBILITY
Officer / Executive.
4.0 ACCOUNTABILITY
Department Head
5.0 PROCEDURE
5.1 PROCEDURE FOR GENERAL CLEANING
5.1.1 Ensure that the power supply to the instrument is switched OFF before cleaning.
5.1.2 De-dust the instrument with a clean dry cloth every day.
5.1.3 Once in a week remove adhered dust by wet mopping using detergent solution.
Afterwards wipe the surface with a clean dry cloth to remove traces of detergent.
5.1.4 Caution to be taken to clean the oven immediately with dry cloth to remove the moisture.
5.2 PROCEDURE FOR OPERATION
5.2.1 Switch on the instrument and wait for 30 minutes for heating and stabilizing the lamp.
5.2.2 Then turn on P.C and the Printer.
5.2.3 Go to ‘Buck IR’ icon and double click, and Wait for software initialize with following Word Checking For attached instruments please wait……..
5.2.4 Click on ‘instrument ,’and also Click on ‘Adjust parameters’ and Give the Following parameters For Set up Options .
Optical Mode : Transmission
Scan time : 3
Gain setting : 0
Pen Responsive : 0.1
Scan type : Reference.
5.2.5 In case of Liquid cell, Change Optical Mode to Absorbance by keeping the rest of the parameters as such.
5.2.6 After Setting this, Instrument shows this parameters in its Screen.
5.2.7 5.2.7 Click Instrument and go to Communication parameters . Give Following parameters as a Communication parameters.
Communication Configuration
COM Port : COM1
Baud Port : 2400
Parity : none
Stop bits : 1
Data bits : 8
Click OK for Setting the above parameters in Instrument.
5.2.8 Click on ‘Instrument’ and Go to ‘Scan Sample’
This system Will assign Scan sample.
5.2.9 In Scan Sample, Give 4000 ,600 for start & end wave numbers respectively.
5.2.10 System will show Single beam energy profile and will beep during scan. This is considered as Blank Spectrum.(Air back ground spectrum)
5.3 PREPARATION SAMPLE PELLET:
5.3.1 Weigh about 400 mg of potassium bromide (IR spectroscopy grade, previously dried in-between 1200-1300 C ).
5.3.2 Transfer the weighed material to porcelain mortar & pestle.
5.3.3 Weigh accurately 4 mg of testing sample and transfer it to potassium bromide containing mortar.
5.3.4 Grind and mix well.
5.3.5 Weigh accurately 150 mg of mixed sample and transfer this to the pellet making accessory, using KBr press instrument as per SOP.No: BGQC009-00 pellet is
prepared.
5.4 SAMPLE MEASURMENT
5.4.1 Place the sample pellet, in pellet terminal and give the file name in Scan sample (procedure same as described in air spectrum) and Click OK.
5.4.2 System will show single beam energy profile and will give beep during scan. After scan processing, Go to Arithmetic function .Click Transmission, and select the Correct background(Air spectrum) file from file list . Click on OK. Software will generate the % of Scan for that Sample. This is considered as Sample spectrum.
5.4.3 Go to peak function, adjust peak-threshold and Click on View peaks.
5.4.4 Go to File, select File information and give the following parameters:
Memo : Name of sample analyzed
Method : KBR PELLETE
Instrument : BUCK IR
5.4.5 Click on OK. This is useful for future reference.
5.4.6 Go to View function, Select Overlaid Option for Comparison with Reference spectrum.
5.4.7 Go to File function, select print set-up& print for taking print-out of Scanned spectrum
5.4.8 Go to peak function select print peaks report for peaks report of scanned spectrum.
5.5 CALIBRATION
5.5.1 RESOLUTION
Record the spectrum of a polystyrene film 0.05 mm in thickness.
5.5.2 ACCEPTANCE CRETERIA
5.5.2.1 The depth of the trough from the maximum at about 2851 cm-1 and 2870cm-1 should be greater than 18 % transmittance
5.5.2.2 The depth of the trough from the maximum at about 1586 cm-1 and 1589cm-1 should be grater than 12% transmittance
5.5.3 WAVE NUMBER ACCURACY
5.5.3.1 Record the spectrum of a polystyrene film 0.05 mm in thickness.
5.5.4 ACCETANCE CRITERIA
5.5.4.1 It should give the maxima at the following wave numbers within the acceptable range.
S. No: 1.
WAVE NUMBER 2850.7
ACCEPTABLE RANGE 2846.7 ----- 2854.7
S. No: 2.
WAVE NUMBER 1601.4
ACCEPTABLE RANGE 1597.4 ----- 1605.7
S. No: 3.
WAVE NUMBER 906.7
ACCEPTABLE RANGE 902.7 ----- 1000.7
5.5.5 Record the results in the calibration record as per Annexure-1
5.5.6 Affix a ‘CALIBRATED’ label on the instrument.
5.6 Report any discrepancy observed during calibration or operating the instrument to Department Head and notify the defect to utility / service engineer to rectify the defect. Affix “BREAK DOWN” label on the instrument till it gets rectified.
5.7 FREQUENCY OF CALIBRATION
Once in three months and after each maintenance job.
6.0 REASON FOR REVIEW:
First time issue.
SOP - OPERATION PROCEDURE FOR MAGNETIC STIRRER
1.0 OBJECTIVE
To ensure that Magnetic Stirrer with hot plate performs satisfactorily.
2.0 SCOPE
This sop covers the operation procedure for Magnetic stirrer with hot plate and this is applicable to Quality control department..
3.0 RESPONSIBILITY
Quality Control officer/ Executive.
4.0 ACCOUNTABILITY
Department Head.
5.0 PROCEDURE
5.1 PROCEDURE FOR CLEANING
5.1.1 Ensure that the power supply to the instrument is switched OFF before cleaning.
5.1.2 De dust the instrument with a clean dry cloth every day.
5.1.3 Once in a week remove adhered dust by wet mopping using detergent solution. Afterwards wipe the surface with a clean dry cloth to remove traces of detergent.
5.2 OPERATING PROCEDURE
5.2.1 Ensure that the instrument is connected to the power supply.
5.2.2 Place the beaker containing the solution to be stirred in the center of the top plate and immerse the Teflon paddle into the solution.
5.2.3 Switch on the instrument, the pilot lamp gets illuminated.
5.2.4 The revolution of the stirring paddle is increased to the required stirring speed by means of speed regulator.
5.2.5 After stirring is over slowly decrease the speed of stirring paddle to zero.
5.2.6 For heater, Set the temperature by rotating the temperature setting knob to the required. This heater Knob is applicable wherever it is required.
5.2.7 Report any discrepancy observed during operating the instrument to Department Head and notify the defect to Technical / Service engineer to rectify the defect. Affix “BREAK DOWN” label on the instrument till it get rectified.
6.0 REASON FOR REVIEW
First time issue.
To ensure that Magnetic Stirrer with hot plate performs satisfactorily.
2.0 SCOPE
This sop covers the operation procedure for Magnetic stirrer with hot plate and this is applicable to Quality control department..
3.0 RESPONSIBILITY
Quality Control officer/ Executive.
4.0 ACCOUNTABILITY
Department Head.
5.0 PROCEDURE
5.1 PROCEDURE FOR CLEANING
5.1.1 Ensure that the power supply to the instrument is switched OFF before cleaning.
5.1.2 De dust the instrument with a clean dry cloth every day.
5.1.3 Once in a week remove adhered dust by wet mopping using detergent solution. Afterwards wipe the surface with a clean dry cloth to remove traces of detergent.
5.2 OPERATING PROCEDURE
5.2.1 Ensure that the instrument is connected to the power supply.
5.2.2 Place the beaker containing the solution to be stirred in the center of the top plate and immerse the Teflon paddle into the solution.
5.2.3 Switch on the instrument, the pilot lamp gets illuminated.
5.2.4 The revolution of the stirring paddle is increased to the required stirring speed by means of speed regulator.
5.2.5 After stirring is over slowly decrease the speed of stirring paddle to zero.
5.2.6 For heater, Set the temperature by rotating the temperature setting knob to the required. This heater Knob is applicable wherever it is required.
5.2.7 Report any discrepancy observed during operating the instrument to Department Head and notify the defect to Technical / Service engineer to rectify the defect. Affix “BREAK DOWN” label on the instrument till it get rectified.
6.0 REASON FOR REVIEW
First time issue.
SOP - OPERATION PROCEDURE FOR HYDRAULIC PRESS (KBr PRESS)
1.0 OBJECTIVE
To lay down a procedure for Operation of Hydraulic Press.
2.0 SCOPE
This sop covers the operation procedure for hydraulic press and is applicable to Quality control department..
3.0 RESPONSIBILITY
Executive.
4.0 ACCOUNTABILITY
Department Head.
5.0 PROCEDURE
5.1 GENERAL CLEANING PROCEDURE
5.1.1 Clean the instrument with a clean dry cloth every day.
5.1.2 Occasionally wet cloth dipped in dilute soap solution may be used.
5.1.3 Precaution to be taken to clean the instrument immediately with dry cloth to remove the moisture.
5.2 OPERATING PROCEDURE
5.2.1 Clean the plunger and Anvil with Solvent to remove Grease.
5.2.2 Assemble the Top and Bottom Guide.
5.2.3 Insert Anvil with polished surface facing upwards in the Top Guide.
5.2.4 Fill evenly 400gm – 500 gm Potassium bromide ( Spectroscopy Grade) and 4 -5mg Sample on the Anvil surface and spread it using Plunger. For best results. Use only Spectroscopic Grade KBr and heat it at 110o in Oven before use.
5.2.5 Insert Plunger facing polished surface down-wards.
5.2.6 Place the small ‘O’ Ring around the Plunger and push it up to the top S.S. Guide.
5.2.7 Place the assembled Die on the cover plate of the Cylinder of the Press. Move the Screw with handle until it touches the Plunger.
5.2.8 Apply Vacuum .
5.2.9 Close the Release Knob by turning clockwise.
5.2.10 Use manual handle to apply pressure.
5.2.11 Required pressure normally is 10 to 15 kg /cm2
5.2.12 Never exceed 15 kg/ cm2 on the die though the Press
5.2.13 Release pressure and vacuum after five minutes.
5.2.14 Dismantle top and Bottom guides and using extractor ring provided apply pressure from the reverse side to remove Pellet.
5.2.15 Clean all traces of KBr press and store the Die in Dessicator.
5.3 PRECAUTIONS
5.3.1 All the parts of the Die should be kept absolutely clean by removing traces of KBr press and Dust.
5.3.2 Use only soft tissue paper moistened with solvent for cleaning.
5.3.3 Do not excess pressure than required on the Die.
5.3.4 Store the Die in dessicator after cleaning thoroughly. The Anvil and Plunger should be kept wrapped in Aluminum Foil and then in the Dessicator. Alternatively the Anvil and Plunger can be kept immersed in Liquid Paraffin.
5.3.5 Use only moisture free dry Spectroscopic Grade Potassium bromide.
5.4 CALIBRATION
5.4.1 Gauge Calibration shall be done through Utility department once a year and after each maintenance job.
6.0 REASON FOR REVIEW:
First time issue.
To lay down a procedure for Operation of Hydraulic Press.
2.0 SCOPE
This sop covers the operation procedure for hydraulic press and is applicable to Quality control department..
3.0 RESPONSIBILITY
Executive.
4.0 ACCOUNTABILITY
Department Head.
5.0 PROCEDURE
5.1 GENERAL CLEANING PROCEDURE
5.1.1 Clean the instrument with a clean dry cloth every day.
5.1.2 Occasionally wet cloth dipped in dilute soap solution may be used.
5.1.3 Precaution to be taken to clean the instrument immediately with dry cloth to remove the moisture.
5.2 OPERATING PROCEDURE
5.2.1 Clean the plunger and Anvil with Solvent to remove Grease.
5.2.2 Assemble the Top and Bottom Guide.
5.2.3 Insert Anvil with polished surface facing upwards in the Top Guide.
5.2.4 Fill evenly 400gm – 500 gm Potassium bromide ( Spectroscopy Grade) and 4 -5mg Sample on the Anvil surface and spread it using Plunger. For best results. Use only Spectroscopic Grade KBr and heat it at 110o in Oven before use.
5.2.5 Insert Plunger facing polished surface down-wards.
5.2.6 Place the small ‘O’ Ring around the Plunger and push it up to the top S.S. Guide.
5.2.7 Place the assembled Die on the cover plate of the Cylinder of the Press. Move the Screw with handle until it touches the Plunger.
5.2.8 Apply Vacuum .
5.2.9 Close the Release Knob by turning clockwise.
5.2.10 Use manual handle to apply pressure.
5.2.11 Required pressure normally is 10 to 15 kg /cm2
5.2.12 Never exceed 15 kg/ cm2 on the die though the Press
5.2.13 Release pressure and vacuum after five minutes.
5.2.14 Dismantle top and Bottom guides and using extractor ring provided apply pressure from the reverse side to remove Pellet.
5.2.15 Clean all traces of KBr press and store the Die in Dessicator.
5.3 PRECAUTIONS
5.3.1 All the parts of the Die should be kept absolutely clean by removing traces of KBr press and Dust.
5.3.2 Use only soft tissue paper moistened with solvent for cleaning.
5.3.3 Do not excess pressure than required on the Die.
5.3.4 Store the Die in dessicator after cleaning thoroughly. The Anvil and Plunger should be kept wrapped in Aluminum Foil and then in the Dessicator. Alternatively the Anvil and Plunger can be kept immersed in Liquid Paraffin.
5.3.5 Use only moisture free dry Spectroscopic Grade Potassium bromide.
5.4 CALIBRATION
5.4.1 Gauge Calibration shall be done through Utility department once a year and after each maintenance job.
6.0 REASON FOR REVIEW:
First time issue.
SOP - OPERATION AND CALIBRATION PROCEDURE FOR MELTING POINT APPARATUS
1.0 OBJECTIVE
To lay down a procedure for operation and calibration of melting point apparatus.
2.0 SCOPE
This SOP Covers the operation and calibration procedure of melting point apparatus and is applicable to Quality Control Department.
3.0 RESPONSIBILITY
Officer / Executive.
4.0 ACCOUNTABILITY
Department Head
5.0 PROCEDURE
5.1 PROCEDURE FOR GENERAL CLEANING
5.1.1 Ensure that the power supply to the instrument is switched ‘ OFF’ before cleaning
5.1.2 De-dust the instrument daily externally with a clean dry cloth.
5.1.3 Once in a week remove adhered dust by wet mopping using detergent solution. Afterwards wipe the surface with a clean dry cloth to remove traces of detergent.
5.1.4 Precaution has to be taken to clean the instrument immediately with dry cloth to remove the moisture.
5.2 PROCEDURE FOR OPERATION
5.2.1 Keep the ‘HEATER’ & ‘STIRRER’ Knobs to ‘MIN’.
5.2.2 Switch on the Main power supply. Switch on the ‘MAINS’ of the instrument.
5.2.3 The display will show some random figure, then press the ‘RESET’ push button to display the actual temperature of the furnace.
5.2.4 Keep the melting point tube in silicone oil containing glass container. . Check through the lense type mirror about the capillary is correctly seated in its cavity.
5.2.5 Turn the STIRRER knob slowly towards MAX. Press the START push button.
5.2.6 Turn the heater knob to MAX and put HEATER HIGH/LOW switch to HIGH. ( This switch is provided on right hand side of the instrument ). The raise of temperature can be controlled by using this switch and the HEATER knob.
5.2.7 When the temperature reaches within about 30 o C, of the expected melting point, reduce the rate of heating and adjust the rate of rise of temperature to about 1 o C, per minute.
5.2.8 Wait till the melting point is reached which is indicated by sample is melted in the tube. The digital read-out will display the exact temperature at which the sample is melted. Record this temperature. Turn off the ’HEATER’ Knob.
5.2.9 After reducing the temperature, switched off the instrument .
5.3 PRECAUTIONS
5.3.1 Care should be taken while inserting the capillary into its cavity or taking out from the cavity to avoid breaking, take it out vertically.
5.3.2 Check always colour of the silicone oil. Normally it is colourless. If it observed as yellow or brown, discard the oil. And take fresh oil in that container.
5.4 CALIBRATION PROCEDURE
5.4.1 Follow the cleaning procedure mentioned in the steps 5.1 to 5.4.
5.4.2 Check the melting points of the following Reference Standards as per the steps of operating procedure 5.2.1 to 5.2.9.
Standard Benzoic acid USP RS
melting range 121.0°C - 123.0°C
Standard Caffeine USP RS
melting range 235.0°C – 239.0°C
5.4.3 Record all the results in the calibration record as per Annexure – I.
5.4.4 Affix a ‘CALIBRATED’ label on the instrument
5.4.5 Report any discrepancy observed during calibration or operating the instrument to Department Head and notify the defect to utility department to rectify the defect. Affix “BREAK DOWN” label on the instrument till it get rectified.
5.4.6 Frequency of calibration
Once a month and after each maintenance job.
6.0 acceptance criteria
The melting point of reference standard should be within limit mentioned in the calibration procedure as melting range.
7.0 REASON FOR REVIEW:
First time issue.
To lay down a procedure for operation and calibration of melting point apparatus.
2.0 SCOPE
This SOP Covers the operation and calibration procedure of melting point apparatus and is applicable to Quality Control Department.
3.0 RESPONSIBILITY
Officer / Executive.
4.0 ACCOUNTABILITY
Department Head
5.0 PROCEDURE
5.1 PROCEDURE FOR GENERAL CLEANING
5.1.1 Ensure that the power supply to the instrument is switched ‘ OFF’ before cleaning
5.1.2 De-dust the instrument daily externally with a clean dry cloth.
5.1.3 Once in a week remove adhered dust by wet mopping using detergent solution. Afterwards wipe the surface with a clean dry cloth to remove traces of detergent.
5.1.4 Precaution has to be taken to clean the instrument immediately with dry cloth to remove the moisture.
5.2 PROCEDURE FOR OPERATION
5.2.1 Keep the ‘HEATER’ & ‘STIRRER’ Knobs to ‘MIN’.
5.2.2 Switch on the Main power supply. Switch on the ‘MAINS’ of the instrument.
5.2.3 The display will show some random figure, then press the ‘RESET’ push button to display the actual temperature of the furnace.
5.2.4 Keep the melting point tube in silicone oil containing glass container. . Check through the lense type mirror about the capillary is correctly seated in its cavity.
5.2.5 Turn the STIRRER knob slowly towards MAX. Press the START push button.
5.2.6 Turn the heater knob to MAX and put HEATER HIGH/LOW switch to HIGH. ( This switch is provided on right hand side of the instrument ). The raise of temperature can be controlled by using this switch and the HEATER knob.
5.2.7 When the temperature reaches within about 30 o C, of the expected melting point, reduce the rate of heating and adjust the rate of rise of temperature to about 1 o C, per minute.
5.2.8 Wait till the melting point is reached which is indicated by sample is melted in the tube. The digital read-out will display the exact temperature at which the sample is melted. Record this temperature. Turn off the ’HEATER’ Knob.
5.2.9 After reducing the temperature, switched off the instrument .
5.3 PRECAUTIONS
5.3.1 Care should be taken while inserting the capillary into its cavity or taking out from the cavity to avoid breaking, take it out vertically.
5.3.2 Check always colour of the silicone oil. Normally it is colourless. If it observed as yellow or brown, discard the oil. And take fresh oil in that container.
5.4 CALIBRATION PROCEDURE
5.4.1 Follow the cleaning procedure mentioned in the steps 5.1 to 5.4.
5.4.2 Check the melting points of the following Reference Standards as per the steps of operating procedure 5.2.1 to 5.2.9.
Standard Benzoic acid USP RS
melting range 121.0°C - 123.0°C
Standard Caffeine USP RS
melting range 235.0°C – 239.0°C
5.4.3 Record all the results in the calibration record as per Annexure – I.
5.4.4 Affix a ‘CALIBRATED’ label on the instrument
5.4.5 Report any discrepancy observed during calibration or operating the instrument to Department Head and notify the defect to utility department to rectify the defect. Affix “BREAK DOWN” label on the instrument till it get rectified.
5.4.6 Frequency of calibration
Once a month and after each maintenance job.
6.0 acceptance criteria
The melting point of reference standard should be within limit mentioned in the calibration procedure as melting range.
7.0 REASON FOR REVIEW:
First time issue.
SOP - STANDARDISATION OF THERMOMETERS
1.0 OBJECTIVE
To ensure that the thermometers give accurate and reproducible temperature reading.
2.0 SCOPE
This SOP Covers Standardisation procedure of thermometer and is applicable to Quality Control Department.
3.0 RESPONSIBILITY
Officer / Executive.
4.0 ACCOUNTABILITY
Department Head.
5.0 PROCEDURE
5.0.1 The thermometer for calibration shall be mercury in glass type.
5.0.2 Take a 500 ml beaker filled with about 400 ml of Silicon Oil. Use water for (0-50oC) and Silicon Oil for the temperature above 50oC.
5.0.3 Place the beaker on a bath fitted with a stirrer. The stirrer shall be dipped in the beaker leaving about 2 cm space from the bottom of beaker.
5.0.4 Immerse the standard thermometer certified by Approved Laboratory, into the Silicon Oil vertically approx. 8.0 cm leaving the remainder of the stem and the upper expansion chamber exposed to ambient temperature. Clamp tightly.
5.0.5 Immerse the thermometer to be calibrated into the Silicon Oil vertically. The mercury bulb of the thermometer shall be placed at the same level of the mercury bulb of the standard thermometer. Clamp tightly.
5.0.6 Start the stirrer taking precaution that it does not touch the thermometers.
5.0.7 Start heating the oil bath and compare the temperature observed at different increments as given below.
S.No 1
Range of thermometer -10 oC to 50 oC
Set Temp. for Standardization
i. 0 oC
ii. 10 oC
iii. 25 oC
iv. 35 oC
v. 45 oC
Acceptance Limit ± 0.5 oC
S.No 2
Range of thermometer -10 oC to 110oC
Set Temp. for Standardization
i. 0 oC
ii. 25 oC
iii. 50 oC
iv. 80 oC
v. 100 oC
Acceptance Limit ± 1.0 oC
S.No 3
Range of thermometer -10 oC to 250 oC
Set Temp. for Standardization
i. 0 oC
ii. 60 oC
iii. 120 oC
iv. 180 oC
v. 240 oC
Acceptance Limit ± 1.0 oC
S.No 4
Range of thermometer -10 oC to 360 oC
Set Temp. for Standardization
i. 0 oC
ii. 60 oC
iii. 120 oC
iv. 180 oC
v. 250 oC
Acceptance Limit ± 2.0 oC
5.0.8 Any thermometer found beyond the acceptable limit shall be discarded.
5.1 IDENTIFICATION NUMBER
5.1.1 Identification number shall be 10 characters.
5.1.2 The first two characters shall always be “QC” denotes Quality control department.
5.1.3 Third and fourth digits shall always be ‘C’ and ‘T’ respectively. It denotes calibrated thermometer.
5.1.4 Fifth character shall always be hyphen (-).
5.1.5 Sixth and seventh character shall be numeric and denote original number.
5.1.6 The eighth character shall be slash ( / ).
5.1.7 The ninth and tenth character shall be numeric and shall denote number of re-calibration.(version)
5.1.8 A typical example shall be as follows:
Q C C T - 0 1 / 0 0
5.1.9 The thermometer shall have an identification number and standardization date labelled on it.
5.2 CALIBRATION
5.2.1 All thermometers shall be standardized once in a year and calibration record maintained as per annexure-I.
6.0 REASON FOR REVIEW:
First time issue.
To ensure that the thermometers give accurate and reproducible temperature reading.
2.0 SCOPE
This SOP Covers Standardisation procedure of thermometer and is applicable to Quality Control Department.
3.0 RESPONSIBILITY
Officer / Executive.
4.0 ACCOUNTABILITY
Department Head.
5.0 PROCEDURE
5.0.1 The thermometer for calibration shall be mercury in glass type.
5.0.2 Take a 500 ml beaker filled with about 400 ml of Silicon Oil. Use water for (0-50oC) and Silicon Oil for the temperature above 50oC.
5.0.3 Place the beaker on a bath fitted with a stirrer. The stirrer shall be dipped in the beaker leaving about 2 cm space from the bottom of beaker.
5.0.4 Immerse the standard thermometer certified by Approved Laboratory, into the Silicon Oil vertically approx. 8.0 cm leaving the remainder of the stem and the upper expansion chamber exposed to ambient temperature. Clamp tightly.
5.0.5 Immerse the thermometer to be calibrated into the Silicon Oil vertically. The mercury bulb of the thermometer shall be placed at the same level of the mercury bulb of the standard thermometer. Clamp tightly.
5.0.6 Start the stirrer taking precaution that it does not touch the thermometers.
5.0.7 Start heating the oil bath and compare the temperature observed at different increments as given below.
S.No 1
Range of thermometer -10 oC to 50 oC
Set Temp. for Standardization
i. 0 oC
ii. 10 oC
iii. 25 oC
iv. 35 oC
v. 45 oC
Acceptance Limit ± 0.5 oC
S.No 2
Range of thermometer -10 oC to 110oC
Set Temp. for Standardization
i. 0 oC
ii. 25 oC
iii. 50 oC
iv. 80 oC
v. 100 oC
Acceptance Limit ± 1.0 oC
S.No 3
Range of thermometer -10 oC to 250 oC
Set Temp. for Standardization
i. 0 oC
ii. 60 oC
iii. 120 oC
iv. 180 oC
v. 240 oC
Acceptance Limit ± 1.0 oC
S.No 4
Range of thermometer -10 oC to 360 oC
Set Temp. for Standardization
i. 0 oC
ii. 60 oC
iii. 120 oC
iv. 180 oC
v. 250 oC
Acceptance Limit ± 2.0 oC
5.0.8 Any thermometer found beyond the acceptable limit shall be discarded.
5.1 IDENTIFICATION NUMBER
5.1.1 Identification number shall be 10 characters.
5.1.2 The first two characters shall always be “QC” denotes Quality control department.
5.1.3 Third and fourth digits shall always be ‘C’ and ‘T’ respectively. It denotes calibrated thermometer.
5.1.4 Fifth character shall always be hyphen (-).
5.1.5 Sixth and seventh character shall be numeric and denote original number.
5.1.6 The eighth character shall be slash ( / ).
5.1.7 The ninth and tenth character shall be numeric and shall denote number of re-calibration.(version)
5.1.8 A typical example shall be as follows:
Q C C T - 0 1 / 0 0
5.1.9 The thermometer shall have an identification number and standardization date labelled on it.
5.2 CALIBRATION
5.2.1 All thermometers shall be standardized once in a year and calibration record maintained as per annexure-I.
6.0 REASON FOR REVIEW:
First time issue.
SOP - OPERATION AND CALIBRATION OF MUFFLE FURNACE
1.0 OBJECTIVE
To check the instrument performs satisfactorily and gives accurate temperature.
2.0 SCOPE
This SOP Covers the operation and calibration procedure of Muffle furnace and this SOP is applicable to Quality Control Department.
3.0 RESPONSIBILITY
Officer / Executive
4.0 ACCOUNTABILITY
Department Head.
5.0 PROCEDURE
5.1 CLEANING PROCEDURE
5.1.1 Check that the power supply to the instrument is switched “OFF”.
5.1.2 Ensure that the Muffle Furnace is not in hot condition or in operation while cleaning.
5.1.3 Clean the instrument externally with clean dry cloth.
5.2 OPERATING PROCEDURE
5.2.1 Ensure that the instrument is connected to the power supply.
5.2.2 Switch “ON” the main power supply, glowing of red light at mains indicates the power supply.
5.2.3 Switch on the instrument by ON position which leads to activation of green control bulb and the temperature controller.
5.2.4 Set the temperature required by pressing and holding the red ‘PRESS TO SET’ button and rotate the adjust screw to set the required temperature and release the push button.
5.2.5 The digital display shows the actual temperature of furnace and the red light of the temperature controller glows.
5.2.6 When temperature reaches at the setting point, the red light of temperature controller automatically switched “OFF” and green light will glow. The equipment is now ready for operation.
5.2.7 If any discrepancy observed during operation, inform to maintenance department for rectification.
5.3 CALIBRATION PROCEDURE
5.3.1 Calibration of the temperature will be done through external agency from Calibration Service laboratory.
5.3.2 If any discrepancy observed during operation, stop the instrument and inform to Utility department for rectification and affix “BREAK-DOWN” tag to the instrument .
5.3.3 FREQUENCY OF CALIBRATION
Once a year and after each Maintenance Job.
6.0 REASON FOR REVIEW
First time issue.
To check the instrument performs satisfactorily and gives accurate temperature.
2.0 SCOPE
This SOP Covers the operation and calibration procedure of Muffle furnace and this SOP is applicable to Quality Control Department.
3.0 RESPONSIBILITY
Officer / Executive
4.0 ACCOUNTABILITY
Department Head.
5.0 PROCEDURE
5.1 CLEANING PROCEDURE
5.1.1 Check that the power supply to the instrument is switched “OFF”.
5.1.2 Ensure that the Muffle Furnace is not in hot condition or in operation while cleaning.
5.1.3 Clean the instrument externally with clean dry cloth.
5.2 OPERATING PROCEDURE
5.2.1 Ensure that the instrument is connected to the power supply.
5.2.2 Switch “ON” the main power supply, glowing of red light at mains indicates the power supply.
5.2.3 Switch on the instrument by ON position which leads to activation of green control bulb and the temperature controller.
5.2.4 Set the temperature required by pressing and holding the red ‘PRESS TO SET’ button and rotate the adjust screw to set the required temperature and release the push button.
5.2.5 The digital display shows the actual temperature of furnace and the red light of the temperature controller glows.
5.2.6 When temperature reaches at the setting point, the red light of temperature controller automatically switched “OFF” and green light will glow. The equipment is now ready for operation.
5.2.7 If any discrepancy observed during operation, inform to maintenance department for rectification.
5.3 CALIBRATION PROCEDURE
5.3.1 Calibration of the temperature will be done through external agency from Calibration Service laboratory.
5.3.2 If any discrepancy observed during operation, stop the instrument and inform to Utility department for rectification and affix “BREAK-DOWN” tag to the instrument .
5.3.3 FREQUENCY OF CALIBRATION
Once a year and after each Maintenance Job.
6.0 REASON FOR REVIEW
First time issue.
SOP - OPERATION AND CALIBRATION OF SCREW GAUGE
1.0 Objective
To lay down procedure to operate and calibrate Screw Gauge.
2.0 SCOPE
This SOP Covers the operation and calibration procedure of screw gauge and is applicable to Quality Control Department.
3.0 Responsibility
Executive.
4.0 Accountability
Department Head
5.0 PROCEDURE
5.1 Procedure for general cleaning
5.1.1 Clean the instrument with a dry clean cloth before and after use.
5.1.2 Always keep the Screw Gauge in the case provided.
5.2 Operating Instructions
5.2.1 Close the measuring faces.
5.2.2 Read the display on counter and thimble.
5.2.3 If the display is not zero adjust it to zero with furnished spanner.
5.2.4 Place the sample between the measuring faces and close smoothly until both measuring faces just touch the sample. Don’t close tightly.
5.2.5 Record the reading displayed.
5.2.6 Take out the sample, clean and keep the Screw Gauge in case.
5.3 CALIBRATION procedure
5.3.1 Calibration of the Screw Gauge will be done through external agency from calibration Service Laboratory.
5.3.2 Report for any discrepancy observed in the calibration report or operation to Department Head and stop using the Micrometer. Affix “BREAK-DOWN” tag to the Screw Gauge and inform to Utility department for rectification.
5.3.3 Frequency of calibration
once a year and after each maintenance job.
6.0 REASON FOR REVIEW
First time issue.
To lay down procedure to operate and calibrate Screw Gauge.
2.0 SCOPE
This SOP Covers the operation and calibration procedure of screw gauge and is applicable to Quality Control Department.
3.0 Responsibility
Executive.
4.0 Accountability
Department Head
5.0 PROCEDURE
5.1 Procedure for general cleaning
5.1.1 Clean the instrument with a dry clean cloth before and after use.
5.1.2 Always keep the Screw Gauge in the case provided.
5.2 Operating Instructions
5.2.1 Close the measuring faces.
5.2.2 Read the display on counter and thimble.
5.2.3 If the display is not zero adjust it to zero with furnished spanner.
5.2.4 Place the sample between the measuring faces and close smoothly until both measuring faces just touch the sample. Don’t close tightly.
5.2.5 Record the reading displayed.
5.2.6 Take out the sample, clean and keep the Screw Gauge in case.
5.3 CALIBRATION procedure
5.3.1 Calibration of the Screw Gauge will be done through external agency from calibration Service Laboratory.
5.3.2 Report for any discrepancy observed in the calibration report or operation to Department Head and stop using the Micrometer. Affix “BREAK-DOWN” tag to the Screw Gauge and inform to Utility department for rectification.
5.3.3 Frequency of calibration
once a year and after each maintenance job.
6.0 REASON FOR REVIEW
First time issue.
SOP - OPERATION AND CALIBRATION OF VERNIER CALLIPER
1.0 OBJECTIVE
To lay down procedure to operate and calibrate Digimatic Vernier Calliper.
2.0 SCOPE
This SOP Covers the operation and calibration procedure of Vernier and is applicable to Quality Control Department.
3.0 RESPONSIBILITY
Officer / Executive.
4.0 ACCOUNTABILITY
Department Head.
5.0 PROCEDURE
5.1 PROCEDURE FOR GENERAL CLEANING
5.1.1 Clean the calliper with dry clean cloth before and after use.
5.1.2 Care has to be taken to remove foreign particles from Measuring Faces.
5.1.3 Always keep the caliper in the case provided.
5.2 PROCEDURE FOR OPERATION
5.2.1 Switch on the caliper by pressing ON / OFF button.
5.2.2 Press ZERO / ABS button.
5.2.3 Press In / mm button for desired output in inches / millimeters.
5.2.4 Check whether the display is 0.00 mm / 0.0000 in as per the mode selected in.
5.2.5 Close the measuring jaws. Read display.
5.2.6 If display is not zero 0.00 mm / 0.0000 in. adjust it to 0.00 mm / 0.0000 in.
5.2.7 Clean the jaws.
5.2.8 Close the jaws completely.
5.2.9 Press the ORIGIN button to get display zero.
5.2.10 Place clean sample in between measuring jaws and close the jaws.
5.2.11 Record the reading displayed.
5.2.12 Switch off the display by pressing ON / OFF button.
5.2.13 Take out the sample, clean the jaws and keep the caliper in case.
5.3 CALIBRATION PROCEDURE
5.3.1 Calibration of the vernier caliper will be done through External calibration Service laboratory.
5.3.2 Report for any discrepancy observed in the Calibration report to Department head and Stop using the Caliper . Affix BREAK-DOWN tag to the Caliper and inform to Utility department for rectification.
5.3.3 FREQUENCY OF CALIBRATION
Once a year and after each Maintenance Job.
6.0 REASON FOR REVIEW
First time issue
To lay down procedure to operate and calibrate Digimatic Vernier Calliper.
2.0 SCOPE
This SOP Covers the operation and calibration procedure of Vernier and is applicable to Quality Control Department.
3.0 RESPONSIBILITY
Officer / Executive.
4.0 ACCOUNTABILITY
Department Head.
5.0 PROCEDURE
5.1 PROCEDURE FOR GENERAL CLEANING
5.1.1 Clean the calliper with dry clean cloth before and after use.
5.1.2 Care has to be taken to remove foreign particles from Measuring Faces.
5.1.3 Always keep the caliper in the case provided.
5.2 PROCEDURE FOR OPERATION
5.2.1 Switch on the caliper by pressing ON / OFF button.
5.2.2 Press ZERO / ABS button.
5.2.3 Press In / mm button for desired output in inches / millimeters.
5.2.4 Check whether the display is 0.00 mm / 0.0000 in as per the mode selected in.
5.2.5 Close the measuring jaws. Read display.
5.2.6 If display is not zero 0.00 mm / 0.0000 in. adjust it to 0.00 mm / 0.0000 in.
5.2.7 Clean the jaws.
5.2.8 Close the jaws completely.
5.2.9 Press the ORIGIN button to get display zero.
5.2.10 Place clean sample in between measuring jaws and close the jaws.
5.2.11 Record the reading displayed.
5.2.12 Switch off the display by pressing ON / OFF button.
5.2.13 Take out the sample, clean the jaws and keep the caliper in case.
5.3 CALIBRATION PROCEDURE
5.3.1 Calibration of the vernier caliper will be done through External calibration Service laboratory.
5.3.2 Report for any discrepancy observed in the Calibration report to Department head and Stop using the Caliper . Affix BREAK-DOWN tag to the Caliper and inform to Utility department for rectification.
5.3.3 FREQUENCY OF CALIBRATION
Once a year and after each Maintenance Job.
6.0 REASON FOR REVIEW
First time issue
SOP - OPERATION AND CALIBRATION PROCEDURE FOR CENTRIFUGE APPARATUS
1.0 OBJECTIVE
To lay down an operating procedure and calibration of Centrifuge apparatus.
2.0 SCOPE
This sop covers operation procedure and calibration for centrifuge apparatus and this sop is applicable to Quality control department.
3.0 RESPONSIBILITY
Officer / Executive.
4.0 ACCOUNTABILITY
Department Head
5.0 PROCEDURE
5.1 PROCEDURE FOR GENERAL CLEANING.
5.1.1 Clean the instrument with dry cloth from inside chamber and outside of the
instrument.
5.1.2 Remove the glass pieces and solution immediately by removing centrifuge head of any breakage of centrifuge tubes observed.
5.1.3 Remove the centrifuge head once in a month, apply grease at threading and fix it properly.
5.2 PROCEDURE FOR OPERATION
5.2.1 Keep the instrument on stable platform.
5.2.2 Before operating the instrument, the speed knob and timer must be in ‘OFF’ position.
5.2.3 Put the main switch and the instrument switch to ‘ON’ position.
5.2.4 Place the equally filled tubes in the cavities of chamber and ensure the balance
of centrifuge tubes by suitable selection of tube position.
5.2.5 Close the lid and set the desired time with timer knob. [The instrument can also be operated without using the timer.]
5.2.6 Slowly increase the speed with the speed knob to the required RPM.
5.2.7 After the time is completed slowly bring the speed knob to ‘OFF’ position, remove the tubes from the chambers, close the lid and switch ‘OFF’ the instrument.
5.2.8 For vibration free performance:
5.2.8.1 Always keep the centrifuge tubes equally either side .
5.2.8.2 Use Rubber cushion for glass tubes.
5.2.9 In case, any discrepancy in instrument performance, inform to Utility department through department head for rectification.
5.3 CALIBRATION
5.3.1 RPM Calibration shall be done through utility department once a year and after each maintenance job.
6.0 REASON FOR REVIEW
First time issue.
To lay down an operating procedure and calibration of Centrifuge apparatus.
2.0 SCOPE
This sop covers operation procedure and calibration for centrifuge apparatus and this sop is applicable to Quality control department.
3.0 RESPONSIBILITY
Officer / Executive.
4.0 ACCOUNTABILITY
Department Head
5.0 PROCEDURE
5.1 PROCEDURE FOR GENERAL CLEANING.
5.1.1 Clean the instrument with dry cloth from inside chamber and outside of the
instrument.
5.1.2 Remove the glass pieces and solution immediately by removing centrifuge head of any breakage of centrifuge tubes observed.
5.1.3 Remove the centrifuge head once in a month, apply grease at threading and fix it properly.
5.2 PROCEDURE FOR OPERATION
5.2.1 Keep the instrument on stable platform.
5.2.2 Before operating the instrument, the speed knob and timer must be in ‘OFF’ position.
5.2.3 Put the main switch and the instrument switch to ‘ON’ position.
5.2.4 Place the equally filled tubes in the cavities of chamber and ensure the balance
of centrifuge tubes by suitable selection of tube position.
5.2.5 Close the lid and set the desired time with timer knob. [The instrument can also be operated without using the timer.]
5.2.6 Slowly increase the speed with the speed knob to the required RPM.
5.2.7 After the time is completed slowly bring the speed knob to ‘OFF’ position, remove the tubes from the chambers, close the lid and switch ‘OFF’ the instrument.
5.2.8 For vibration free performance:
5.2.8.1 Always keep the centrifuge tubes equally either side .
5.2.8.2 Use Rubber cushion for glass tubes.
5.2.9 In case, any discrepancy in instrument performance, inform to Utility department through department head for rectification.
5.3 CALIBRATION
5.3.1 RPM Calibration shall be done through utility department once a year and after each maintenance job.
6.0 REASON FOR REVIEW
First time issue.
SOP -OPERATION AND CALIBRATION PROCEDURE FOR pH METER. ( MAKE: DIGISUN)
1.0 Objective
To ensure that the instrument performs satisfactorily and gives accurate and reproducible results.
2.0 SCOPE
This SOP Covers the operation and calibration procedure for pH meter and is applicable to Quality Control Department.
3.0 Responsibility
Officer / Executive.
4.0 Accountability
Department Head
5.0 PROCEDURE
5.1 Procedure for general cleaning
5.1.1 Ensure that the power supply to the instrument is switched OFF before cleaning.
5.1.2 De dust the equipment daily externally with a clean dry cloth.
5.1.3 Once in a week remove adhered dust by wet mopping using detergent solution. Afterwards wipe the surface with a clean dry cloth to remove traces of detergent.
5.1.4 Precaution has to be taken to clean the instrument immediately with dry cloth to remove the moisture.
5.2 OPERATING PROCEDURE
5.2.1 Switch on the instrument using power on/off switch in the rare of the instrument. Warm up the instrument for just a minute or two.
5.2.2 Keep the SELECTOR in pH mode and the TEMP control knob at 250 C.
5.2.3 The display should read 7.00, otherwise adjust the pH to 7.00 by using the SET 7.0 knob and keep the SELECTOR in HOLD position and keep the push button in calibrate mode only.
5.2.4 Wash the electrode with distilled water and wipe of the moisture.
5.2.5 Dip the electrode in sample beaker and stir the beaker for a while.
5.2.6 Release the push button switch after a minutes stirring of beaker and record the pH of the sample.
5.3 CALIBRATION
5.3.1 Preparation of standard buffer solution.
5.3.1.1 Buffer pH 4.01 : Prepare a 1.021 % w/v solution of Potassium hydrogen phthalate, previously dried at 110 to 135°C for 2 hours.
5.3.1.2 Buffer pH 6.87 : Prepare a mixture 0.340%w/v solution of Potassium dihydrogen phosphate and 0.355 % w/w solution anhydrous disodium hydrogen phosphate, both previously dried at 110 to 135°C for 2 hours.
5.3.1.3 Buffer pH 9.18 : Prepare 0.3814 % w/v solution of Sodium tetraborate. Protect this solution from carbon dioxide.
5.3.1.4 Set the instrument by using pH 4.01 buffer solution and pH 9.18 buffer solutions
5.3.2 Repeat the operations 5.2.1 to 5.2.4
5.3.3 Take the 4.01 buffer into a suitable beaker and dip the electrode into it and stir for a while, release the push button to read the pH.
5.3.4 If it should read 4.01, otherwise adjust it to 4.01 by adjusting the Slope screw which is provided at rear of the instrument.
5.3.5 Turn the SELECTOR to hold position and push button to Read position.
5.3.6 Take out the electrode and wash with water, wipe of the moisture.
5.3.7 Take the 9.18 buffer into a suitable beaker and dip the electrode into it and stir for a while, adjust SET BUFFER screw to 9.18 .
5.3.8 Turn the SELECTOR to hold position and push button to check position.
5.3.9 Take out the electrode and wash with water, wipe of the moisture.
5.3.10 Calibrate the instrument with 6.87 buffer solution.
5.3.11 Take the 6.87 buffer solution into a suitable beaker and dip the electrode into it and stir for a while, release the push button to read the pH.
5.3.12 Measure the pH and record in the format as per Annexure – I
5.4 FREQUENCY OF CALIBRATION
5.4.1 Calibrate the instrument everyday before using the instrument
5.5 SAMPLE MEASUREMENT
5.5.1 Before sample measurement Select two Buffer solutions for standardization whose difference in pH does not exceed 4 units and such that the expected pH of the material under test falls between them.
5.6 TROUBLE SHOOTING
5.6.1 Report any discrepancy observed during operation or calibration monitoring to Quality Control Executive and notify the defect to maintenance department
for rectification. Affix “BREAK DOWN” label on the instrument.
5.7 ACCEPTANCE CRITERIA
5.7.1 The pH of 6.87 buffer solution buffer should be within + 0.05
6.0 REASON FOR REVIEW
First time issue.
To ensure that the instrument performs satisfactorily and gives accurate and reproducible results.
2.0 SCOPE
This SOP Covers the operation and calibration procedure for pH meter and is applicable to Quality Control Department.
3.0 Responsibility
Officer / Executive.
4.0 Accountability
Department Head
5.0 PROCEDURE
5.1 Procedure for general cleaning
5.1.1 Ensure that the power supply to the instrument is switched OFF before cleaning.
5.1.2 De dust the equipment daily externally with a clean dry cloth.
5.1.3 Once in a week remove adhered dust by wet mopping using detergent solution. Afterwards wipe the surface with a clean dry cloth to remove traces of detergent.
5.1.4 Precaution has to be taken to clean the instrument immediately with dry cloth to remove the moisture.
5.2 OPERATING PROCEDURE
5.2.1 Switch on the instrument using power on/off switch in the rare of the instrument. Warm up the instrument for just a minute or two.
5.2.2 Keep the SELECTOR in pH mode and the TEMP control knob at 250 C.
5.2.3 The display should read 7.00, otherwise adjust the pH to 7.00 by using the SET 7.0 knob and keep the SELECTOR in HOLD position and keep the push button in calibrate mode only.
5.2.4 Wash the electrode with distilled water and wipe of the moisture.
5.2.5 Dip the electrode in sample beaker and stir the beaker for a while.
5.2.6 Release the push button switch after a minutes stirring of beaker and record the pH of the sample.
5.3 CALIBRATION
5.3.1 Preparation of standard buffer solution.
5.3.1.1 Buffer pH 4.01 : Prepare a 1.021 % w/v solution of Potassium hydrogen phthalate, previously dried at 110 to 135°C for 2 hours.
5.3.1.2 Buffer pH 6.87 : Prepare a mixture 0.340%w/v solution of Potassium dihydrogen phosphate and 0.355 % w/w solution anhydrous disodium hydrogen phosphate, both previously dried at 110 to 135°C for 2 hours.
5.3.1.3 Buffer pH 9.18 : Prepare 0.3814 % w/v solution of Sodium tetraborate. Protect this solution from carbon dioxide.
5.3.1.4 Set the instrument by using pH 4.01 buffer solution and pH 9.18 buffer solutions
5.3.2 Repeat the operations 5.2.1 to 5.2.4
5.3.3 Take the 4.01 buffer into a suitable beaker and dip the electrode into it and stir for a while, release the push button to read the pH.
5.3.4 If it should read 4.01, otherwise adjust it to 4.01 by adjusting the Slope screw which is provided at rear of the instrument.
5.3.5 Turn the SELECTOR to hold position and push button to Read position.
5.3.6 Take out the electrode and wash with water, wipe of the moisture.
5.3.7 Take the 9.18 buffer into a suitable beaker and dip the electrode into it and stir for a while, adjust SET BUFFER screw to 9.18 .
5.3.8 Turn the SELECTOR to hold position and push button to check position.
5.3.9 Take out the electrode and wash with water, wipe of the moisture.
5.3.10 Calibrate the instrument with 6.87 buffer solution.
5.3.11 Take the 6.87 buffer solution into a suitable beaker and dip the electrode into it and stir for a while, release the push button to read the pH.
5.3.12 Measure the pH and record in the format as per Annexure – I
5.4 FREQUENCY OF CALIBRATION
5.4.1 Calibrate the instrument everyday before using the instrument
5.5 SAMPLE MEASUREMENT
5.5.1 Before sample measurement Select two Buffer solutions for standardization whose difference in pH does not exceed 4 units and such that the expected pH of the material under test falls between them.
5.6 TROUBLE SHOOTING
5.6.1 Report any discrepancy observed during operation or calibration monitoring to Quality Control Executive and notify the defect to maintenance department
for rectification. Affix “BREAK DOWN” label on the instrument.
5.7 ACCEPTANCE CRITERIA
5.7.1 The pH of 6.87 buffer solution buffer should be within + 0.05
6.0 REASON FOR REVIEW
First time issue.
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