cGMP and Regulatory Updates

1.0 PURPOSE: To provide a written procedure for collection of swab for cleaning validation. 2.0 SCOPE: Applicable to sample from hard to clean area of cleaned equipments. 3.0 RESPONSIBILITY: Executive Manufacturing, Executive QA, Assistant Manager QA. 4.0 ACCOUNTABILITY: Manager Quality Assurance. 5.0 DEFINITIONS: Nil 6.0 PROCEDURE: 6.1 Check the area / part of the equipment which is hard to clean. 6.2 Select 4 x 4 square inch area of the hard surface to clean. 6.3 Swab the marked area using Readymade Swab in four direction as shown below 6.4 Collect the swab sample as per the sampling plan. 6.5 Collect the swab in clean glass bottle labeled properly. 7.0 REFERENCES: Nil 8.0 ENCLOSURES: Nil 9.0 ABBREVIATION: 9.1 QA : Quality Assurance

1.0 PURPOSE: To provide a written procedure for determination of average weight of tablets and checking of individual weight variation. 2.0 SCOPE: Applicable to determination of average weight of a tablet during in process checking. 3.0 RESPONSIBILITY: Operator Manufacturing, Executive Manufacturing and Executive QA. 4.0 ACCOUNTABILITY: Assistant Manager Manufacturing. 5.0 DEFINITIONS: Nil 6.0 PROCEDURE: 6.1 AVERAGE WEIGHT OF A TABLET: 6.1.1 Check the cleanliness of the balance. 6.1.2 Collect Sample of 20 tablets. 6.1.3 Weigh the tablets, record the weight in BMR. 6.1.4 Calculate the average weight of tablet. 6.1.5 Calculate the mean (average weight of tablets) of average weight of each in Process check. 6.2 CHECKING OF INDIVIDUAL WEIGHT VARIATION: 6.2.1 Collect sample of 20 tablets. 6.2.2 Weigh the tablets, record the weight in BMR. 6.2.3 Calculate the average weight of tablet. 6.2.4 Weigh 20 individual tablets one by one and record the observations in the BMR ind...

1.0 PURPOSE: To provide a written procedure for entry of time in documents. 2.0 SCOPE: This procedure is applicable to all documents. 3.0 RESPONSIBILITY: Executives – All concerned departments 4.0 ACCOUTNABILITY: Manager Quality Assurance 5.0 DEFINITIONS: Nil 6.0 PROCEDURE: 6.1 Mention time in hours in documents. e.g., Morning 8.00 AM : write as 8:00 Hrs. Afternoon 2:45 PM: write as 14:45 Hrs. Evening 6:00 PM: write as 18:00 Hrs. 6.2 Change the date after 24:00 Hrs. 7.0 REFERENCES: Nil 8.0 ENCLOSURES: Nil 9.0 ABBREVIATIONS: 9.1 Hrs.: Hours

1.0 PURPOSE: To provide a written procedure to describe the steps to be followed for using purified water. 2.0 SCOPE: This procedure is applicable for usage of Purified water from all user point. 3.0 RESPONSIBILITY: Executive Manufacturing 4.0 ACCOUNTABILITY: Plant Manager 5.0 DEFINITIONS: Nil 6.0 PROCEDURE: 6.1 For usage of Purified water, open the valve of user point at maximum flow and allow the water to run for about one minute before taking it for use. 6.2 In the locations where hosepipes are connected to user point, use water from the end of hosepipe and allow the water to run for about one minute before taking it for usage. 6.3 Connect the hosepipe before usage and disconnect after operation. 6.4 Use separate hosepipes for potable water and purified water. 6.5 Drain the hosepipe and dry after the usage. 6.6 After ensuring the inner wall of the hosepipe is dry, close both the ends with aluminum foil and preserve until next use. 7.0 REFERENCES: Nil 8.0 ENCLOSURES: Nil 9.0...

1.0 PURPOSE: To provide a written procedure for screening and control of raw materials (API & Excipients) for TSE/ BSE risk. 2.0 SCOPE: This procedure covers screening and control of raw materials (API & Excipients) for TSE/ BSE risk. 3.0 RESPONSIBILITY: Plant Head, Manager Quality Control and Manager Quality Assurance. 4.0 ACCOUNTABILITY: Manager Quality Assurance 5.0 DEFINITIONS: Nil. 6.0 PROCEDURE: 6.1 The QA Department shall prepare a questionnaire to qualify suppliers with respect to BSE/TSE risk. 6.2 This questionnaire shall be approved by Manager QA. 6.3 This procedure shall include the screening and controls that are required in qualifying supplier to assure that raw materials procured are free from BSE / TSE risk. 6.4 The QA Department shall require the material Purchase department to purchase only from such manufactures who have fulfilled criteria described in this document. 6.5 QA shall provide the questionnaire to Purchase department for...

Name of the Supplier : ___________________________________ Address : ___________________________________ ___________________________________ ____________________________________ Telephone No. : ____________________________________ Contact Person : ____________________________________ Material Supplied : ____________________________________ 1. Does the material to be supplied have any animal derived ingredients?  YES  NO 2. If yes, which animal species it is derived from? 3. Is the animal a ruminant? (Refer to Note 1 below for a definition and list of ruminant animals)  YES  NO a) If the animal is ruminant , answer to the following: From which tissue of the animal, the ingredient is derived? (Examples: Lungs , Intestines , Brain, Liver ,Spine , Skin , Bones , Blood , Serum , etc) b) Is the animal from which the material is derived born/brought up / slaughtered in a...

1.0 PURPOSE: To provide a written procedure for sampling of Blend and Bulk finished product. 2.0 SCOPE: Applicable to In process sampling. 3.0 RESPONSIBILITY: Executive Manufacturing , Executive QA and Assistant Manager QA. 4.0 ACCOUNTABILITY: Manager Quality Assurance 5.0 DEFINITIONS: Nil 6.0 PROCEDURE: 6.1 SAMPLING OF BLEND: 6.1.1 Sampling of Blend is done after unloading the blend in to IPC, Sample is collected from all IPC, Composite sample is made by mixing samples collected from all IPC in sample bag, Label the sample with proper information. 6.2 SAMPLING OF BULK FINISHED TABLET / CAPSULE: 6.2.1 Collect about 10 tablet / capsule in a sample bag at each time during individual weight variation checking. At the end of batch pooled composite sample from the same is sent to Quality control analysis. 6.3 PROCESS VALIDATION SAMPLING: 6.3.1 During Process validation, sampling is done as per the protocol 6.3.2 In process validation samples are collected in triplicate from ea...

1.0 PURPOSE: To provide a written procedure for the Operation and Cleaning of Hardness Tester (Monsanto Type). 2.0 SCOPE: Applicable to Hardness Tester (Monsanto Type ) used for checking Tablet Hardness in production. 3.0 RESPONSIBILITY: Executive Manufacturing and Executive QA, Assistant Manager QA. 4.0 ACCOUNTABILITY: Manager Quality Assurance 5.0 DEFINITIONS: Nil 6.0 PROCEDURE: 6.1 OPERATION: 6.1.1 Hold one tablet between the two faces provided by pushing forward the movable face inside by turning the plunger clockwise. Coincide the `Zero' in the scale with the pointer. 6.1.2 Enclose front part where tablet is held in a sample polybag. 6.1.3 Start applying pressure on the tablet by gently rotating the plunger 6.1.4 When the tablet breaks, note the hardness (in kg/sqcm) directly from the scale. In case, if the pointer is in between the two divisions of scale, read the hardness as 0.5 kg / sq.cm. 6.1.5 Discard the broken tablets in water a...

1.0 PURPOSE: To provide a written procedure for operation and cleaning of the Automated Friabilator EF-2 (USP) . 2.0 SCOPE: Applicable to determine Friability of tablets in Manufacturing. 3.0 RESPONSIBILITY: Executive Manufacturing,Executive QA and Assistant Manager QA. 4.0 ACCOUNTABILITY: Manager Quality Assurance 5.0 DEFINITIONS: Nil 6.0 PROCEDURE: 6.1 OPERATION: 6.1.1 Check cleanliness of the equipment. 6.1.2 Switch ON the instrument, drum will initialize itself to the loading position, the display will now show START. 6.1.3 Weigh and record the weight of the tablets. A. For the tablets having individual weight up to 0.650 g take 20 tablets. B. For the tablets having individual weight above 0.650 g take 10 tablets. 6.1.4 Adjust the counts to 100 by pressing the COUNT key followed by ‘1’, ‘0’, ‘0’ keys. (Count range 1 to 99999). 6.1.5 Press ENTER to confirm the reading. 6.1.6 To see and confirm the number of counts press COUNT key. 6.1.7 On confirming the numb...

1.0 PURPOSE To provide a written procedure for the Differential Pressure Monitoring. 2.0 SCOPE: This procedure is applicable to all Magnehelic gauges in shop floor. 3.0 RESPONSIBILITY: Concerned Departmental Executives and Departmental Heads. 4.0 ACCOUNTABILITY: Plant Manager Manager Quality Assurance 5.0 DEFINITIONS: Nil 6.0 PROCEDURE: 6.1 Ensure that all the doors are closed before noting the differential pressure. 6.2 Record the differential pressure in ‘Differential Pressure Recording Format’ Refer QAGN:xxxxx Note readings at about 10.00 hrs.  30 mins., 14.00 hrs  30 mins, and 16.30 hrs. 30 mins. 6.3 If the differential pressure is not complying with the acceptance criteria do not proceed for activity in that particular area. Inform QA and Maintenance through the format ‘Intimation Note for Differential Pressure Correction’ Refer format No. QAGN:xxxxxx, send an intimation note to Maintenance department for corrective action. 6.4 After the differential pressure ...

1.0 DISTRIBUTION All Departments. 2.0 APPLICABLE DOCUMENTS INA-03-001 Environment, Health and Safety Policy INA-03-003 General Plant Health and Safety 3.0 APPLICABLE FORMS Nil 4.0 APPLICABILITY This procedure applicable to Xxx India Pvt Ltd, Xxx Plant only 5.0 PURPOSE To provide guidelines for safe handling, usage and storage of compressed gases. 6.0 RESPONSIBLE DEPARTMENTS QA, Production, and Engineering 7.0 RESPONSIBILITY EHS Coordinator 8.0 PROCEDURE 8.1 General 8.1.1 Only experienced and properly trained persons are to handle compressed gases. 8.1.2 Do not remove or deface labels provided by the supplier for the identification of the cylinder contents. 8.1.3 Ascertain the identity of the gas (by carefully seeing the tag, mark or label on it) before using it. Know and understand the properties and hazards associated with each gas before using it. The Material Safety Data Sheet (MSDS) for the gases being used must be available in the vicinity and a copy of the MSDS must be submitte...

1.0 DISTRIBUTION All Departments 1.0 APPLICABLE DOCUMENTS INA-03-001 Environment, Health and Safety Policy INA-03-003 General Plant Safety 3.0 APPLICABLE FORMS INA-03-003-01 Avoid Verbal Instruction Slip INA-03-007-01 Hot Work Permit INA-03-007-02 General Work Permit INA-03-017-01 Confined Space Entry Permit INA-03-008-01 Accident / Injury Report INA-03-008-02 Learning Incident Report 4.0 APPLICABILITY This procedure applicable to Xxx India Pvt Ltd, Xxx Plant 5.0 PURPOSE To establish procedures to be complied by contractors. 6.0 SCOPE To ensure that outside contractors follow all the statutes of the Indian Government and Xxx’s Environment, Health and Safety requirements when executing work on company premises. 7.0 RESPONSIBLE DEPARTMENTS QA, Production and Engineering 8.0 RESPONSIBILITY EHS Coordinator 9.0 DEFINITION A contractor is defined as any person or firm who performs work or provi...

1.0 DISTRIBUTION All Departments 2.0 APPLICABLE DOCUMENTS INM-03-001 Environment, Health and Safety Policy 3.0 APPLICABLE FORM INM-03-008-01 Accident / Injury Report INM-03-008-02 Learning Incident Report INM-03-008-03 Spill Report Form 4.0 APPLICABILITY This process is applicable to Xxx (India) Pvt. Ltd. Xxx plant only. Note: This plan will be reviewed and updated at least annually by end of Q1. 5.0 PURPOSE To outlay procedures to ensure minimum or no injury/loss of life and property during emergencies. The guidelines for emergency situation includes- Natural disasters, Bomb and telephone threats, Fire incidents, Spill occurrences. 6.0 SCOPE This procedure defines the individual responsibilities and procedures for anticipated crisis situations with attitude, logical approach and without panic. 7.0 RESPONSIBLE DEPARTMENT EHS Department QA Department Production Department Engineering Department Logistics Department Service...

1.0 DISTRIBUTION All Departments. 2.0 APPLICABLE DOCUMENTS INA-03-001 Environment Health and Safety Policy 3.0 APPLICABLE FORMS INA-03-003-01 Avoid Verbal Instruction Slip. INA-03-007-01 Hot Work Permit INA-03-007-02 General Work Permit INA-03-008-01 Accident & Injury Report INA-03-008-02 Learning incident Report 4.0 APPLICABILITY This procedure applicable to Xxx India Pvt Ltd, Xxx Plant 5.0 PURPOSE To establish a procedure for Safe work conditions in Plant 6.0 SCOPE This procedure has been developed for the protection of everyone in Xxx Plant premises. For effective implementation, it applies to every employee / visitor / Contractor etc. in Xxx Plant premises. 7.0 RESPONSIBLE DEPARTMENTS QA, Production and Engineering 8.0 RESPONSIBILITY EHS Coordinator 9.0 DEFINITION Learning incident: Any incidence / occurrence that could result in an accident. 10.0 PROCEDURE 10.1 To ensure high safety standards all employees shall strictly follow the below rules: 10.1.1 No work should be done w...

1.0 DISTRIBUTION All Departments. 2.0 APPLICABLE DOCUMENTS INA-03-001 Environment Health and Safety Policy 3.0 APPLICABLE FORMS INA-03-009-01 Safety Inspection Form 4.0 APPLICABILITY This procedure applicable to Xxx India Pvt. Ltd., Xxx Plant 5.0 PURPOSE To establish EHS Committee to implement the team’s EHS Commitments 6.0 SCOPE This procedure describes EHS committee, its duties and responsibilities and rules of operation. 7.0 RESPONSIBLE DEPARTMENTS QA, Production and Engineering 8.0 RESPONSIBILITY EHS Coordinator 9.0 PROCEDURE 9.1 Committee is established to: 9.1.1 Establish and cultivate active participation in maintaining a safe and healthy working environment. 9.1.2 Provide an effective Health and Safety Communication channel. 9.1.3 Promote health and safety awareness, safe work practices and maintain safe working conditions 9.2 Committees Organization There shall be a plant health and safety committee consisting of representatives from each department. 9.2.1 Safety Commit...

1.0 DISTRIBUTION All Departments. 2.0 APPLICABLE DOCUMENTS Xxx Corporate Policy 3.0 APPLICABLE FORMS Nil 4.0 APPLICABILITY This procedure is applicable to Xxx (India) Pvt. Ltd., plant only. 5.0 PURPOSE To describe Xxx Plant Team’s commitment towards Environment, Health and Safety of employees and customers 6.0 SCOPE To state the Environmental, Health and Safety Policy of the Plant. 7.0 RESPONSIBLE DEPARTMENTS All 8.0 RESPONSIBILITY All 9.0 PROCEDURE 9.1 The Team’s EHS Mission: 9.1.1 To be a LEADER in Environmental, Health and Safety (EHS) management and performance. 9.1.2 To produce Xxx products, services, and technologies in workplaces free from environmental and workplace hazards. 9.1.3 To promote culture that recognizes company’s shared values and integrates leading Environmental, Health and Safety principles and practices into business operations. 9.2 The MISSION is achieved through: 9.2.1 Sustainable Development: All employees must conserve our resources, both human and...