cGMP and Regulatory Updates

1.0. PURPOSE: To provide procedure for Calibration of High Pressure Liquid Chromatography. 2.0. SCOPE: Applicable to HPLC Make : Shimadzu Model : LC-2010AHT Pump : LC-10Atvp Detector : SPD-10Avp System Controller : SCL-10Avp Auto Injector : SIL-10Advp 3.0. RESPONSIBILITY: 3.1. Officer -QC 3.2. Executive-QC 4.0. ACCOUNTABILITY: Manager-Quality Control 5.0. DEFINITION: Nil 6.0. PROCEDURE: 6.1. Start the HPLC pump as per IOP and check the flow rate by collecting water in a 10ml measuring cylinder. Using a stop ...

1.0 PURPOSE: To provide a procedure for calibration of balance. 2.0 SCOPE: This covers the calibration procedure for balance. (Instrument No:QC-001) MAKE: SHIMADZU MODEL: LIBROR AEG-45SM 3.0 RESPONSIBILITY: 3.1 Chemist-QC 3.2 Officer-QC 4.0 ACCOUNTABILITY: Manager-QC 5.0 DEFINITION: Nil 6.0 PROCEDURE: 6.1 DAILY 6.1.1. Ensure that balance is aligned properly and cleaned i.e. the spirit level should be in the center of the circle. 6.1.2 6.1.3 Ensure that the display shows 0.00000 Place 4 standard weights of different denominations as per the schedule & record the weight. 6.1.4 The observed weight should confirm with the acceptance criteria as given in the balance log sheet. 6.1.5 If the instrument goes out of calibration contact the service person for necessary adjustment and recalibrate. 6.2. FREQUENCY OF CALIBRATION : Daily 7.0 REFERENCES: Instrument Manual 8.0 ENCLOSURES: Enclosed a table for Acceptance Criteria for Standard Weights, Calibration ...

1.0 PURPOSE: To ensure correct method of operation for balance. 2.0 SCOPE: It covers the procedure for operation of balance MAKE:SHIMADZU MODEL: LIBROR AEG-45SM 3.0 RESPONSIBILITY: Chemist-QC 4.0 ACCOUNTABILITY: Manager-QC 5.0 DEFINITION: Nil 6.0 PROCEDURE: 6.1 Make sure that the balance is kept clean. 6.2 Ensure that the calibration status is valid. 6.3 Ensure that spirit level is in the center of the circle. 6.4 Connect the power cable to the mains and switch ‘ON’. 6.5 Automatically self checking starts from “che-3” & ends with OFF. 6.6 Press ON/OFF key, all the display will glow. 6.7 Press “TARE KEY ”, 0.00000 mark appears on the display. 6.8 The stability of the reading is obtained which is indicated by an arrow mark on the left side of the display. 6.9 Once the stability is attained, the balance is ready for weighing. 6.10 Place the material to be weighed on the pan & note down the reading after the arrow mark appears on the left s...

1.0. PURPOSE: To detailed the procedure for the operation of Distilled water unit. 2.0. SCOPE: Applicable to distilled water unit. 3.0. RESPONSIBILITY: QC Executive 4.0. ACCOUNATABILITY: Manager-QC 5.0. DEFINITION: Nil 6.0.PROCEDURE: 6.1. Ensure the electrical connections are proper. 6.2. Ensure the water circulation is continuous. 6.3. Check for the water level in the heater tank. 6.4. Switch on the instrument. 6.5. Place a clean plastic container meant for distilled water collection at the outlet of the distillation unit and collect the distilled water in it. 6.6. Discard the first 200ml of water and collect the distilled water for lab use. 6.7.Check the clarity visually, if clear, carryout conductivity & chloride test .Conductivity NMT 4.0 m s cm-1 , chloride should be nil. Then use it for regular analysis. 6.8. Instrument when not in use switch off the instrument first and then stop the water connection. 6.9. PRECAUTION: Never switch on the equipment wit...

1.0 PURPOSE : To provide a procedure for change in specification of raw materials. 2.0 SCOPE : Applicable to purchase, stores and QC/QA Department 3.0 RESPONSIBILITIES : It is the responsibility of QC/QA Department/ personnel to assure the right material is used in the formulations. 4.0 PROCEDURE : 4.1 As per the requirement of the product , the specified raw material with specification shall be ordered to the manufacturer/supplier. The manufacturer/supplier will supply the material to the manufacturing site with DC/Invoice 4.2 The store Department prepares the GRN and sends to Q.C. for sampling, testing and release 4.3 Q.C. carries out sampling as per the sampling procedure, tests and approves/rejects the material and GRN shall be passed. 4.4 In case of change in specification the material shall be tested as per the required specification. After testing, passed material shall be dispensed and used. The copy of the test certificat...

1.0 PURPOSE : This procedure describes the method of disposal of expired Finished products/Raw materials. 2.0 SCOPE : Applicable to all Finished products/Raw materials 3.0 RESPONSIBILITY : Quality Control personnel 4.0 PROCEDURE : 4.1 After the expiry of Raw Materials/Finished Products collect all the samples and store separately 4.2 Retain all the expired products for one year after the expiry for destruction. 4.3 The details of expired products waiting for destruction should be entered in the register 4.4 Once in a month, the concerned QC personnel check the expiry of the product. 4.5 Tablets are removed from the bulk containers/strips/ blisters and disposed in a container and destroyed by adding water. 4.6 All the liquid bottles are opened and emptied into the waste disposal 4.7 Empty bottles and caps are crushed and sent to scrap yard 4.8 All expired raw materials are disposed in a container containing water

1.0 PURPOSE : To illustrate the procedure for non moving & expired chemicals. 2.0 SCOPE : It covers all lab chemicals. 3.0 RESPONSIBILITIES : Q.C. chemist. 4.0 PROCEDURE 4.1 The label on the container of the chemical should have date of receipt and validity period 4.2 If the chemical is expired and those items which are not being used for longer time and contaminated chemicals are subjected to disposal. 4.3 The person who disposes the chemical should wear mask, gloves & safety goggles 4.4 The chemical to be disposed is put in a bucket containing water, dissolved and drain into ETP plant. 4.5 After disposal the container is crushed and subjected to scrap. 4.6 Maintain a log book containing chemical no, chemical name, date of disposure, disposed by and checked by etc.

1.0 PURPOSE: To provide a procedure for use of the equipment and instrument after replacing spares or repair. 2.0. SCOPE : It covers the procedure for use of the equipment and instrument after replacing spares or repair. 3.0 RESPONSIBILITY: QC Personnel. 4.0. ACCOUNTABILITY: 5.0. DEFINITION: 6.0. PROCEDURE: Whenever equipment is repaired or spare part is replaced. it should be calibrated before being put into use for routine work. Following steps to be taken in regards to the qualification of the said equipments 6.1. Equipment spare should be correct and as per the specification given in the manual. 6.2. It should be properly installed. 6.3. Calibrate the instrument, it has to comply as per calibration SOP. 6.4. A standard sample previously analysed should be subjected for analysis on the instrument which is being installed. 6.5. Data of analysis of the samples minimum three readings should be compa...

1.0 PURPOSE : This Procedure defines the method of sampling, testing/approval/ non-conformity of intermediates/finished products. 2.0 SCOPE : Applicable to all In process, and Finished Products. 3.0 RESPONSIBILITY : Quality Control & Quality Assurance Personnel. 4.0 PROCEDURE : 4.1 The production department shall send TI/TRF for sampling giving details like Product, Batch No, Batch size, Mfg date and Exp date. 4.2 On receipt of the TI/ TRF, along with sample QC officers shall arrange for Analysis. 4.3 On receipt of the sample, it shall be taken for analysis as per the specification 4.4 The test report shall be prepared by the Chemist, checked by QC Executive/Asst. Manager for approval or non conformance and finally approved by Q.C. Manager. 4.5 In case of finished product, after completion of packing QA chemist shall collect samples of finished pack along with PRRF raised by packing department, which will be submitted to Q.C. for analysis. 4.6 All Approved intermediates and Bulk (T...

1.0. PURPOSE: To provide a procedure for sampling of packing material. 2.0. SCOPE: Applicable to all Packing material. 3.0. RESPONSIBILITY: Quality control Chemist 4.0. ACCOUNTABILITY: Quality Control-Manager 5.0 DEFINITION: Sampling: It is a process of collecting the materials so that the collection shall represent the whole batch of the consignment. Consignment: It is a supply of a material of particular batch intended to be used in different department. Lot: A defined quantity of material made by a specified process cycle having uniform quality. 6.0. PROCEDURE: 6.1. Sampling personnel Sampling shall be carried out by trained personnel who are observant and meticulous. 6.2.SAMPLING PLAN: 6.2.1. All the packages shall be sampled if the lot contains not more than five Containers / packets. If the lot contains 5 to 24 packages, 5 packages shall be sampled. If the lot contains 25 and above packages Ön+1 containers shall be sampled where 'n'...

1.0 PURPOSE : To detail the procedure for sampling. 2.0 SCOPE : Applicable during sampling of all Raw material active ingredients and Inactive ingredients. 3.0 RESPONSIBILITY : All Q.C. Chemists / Officers 4.0 PROCEDURE : 4.1 :SAMPLING PLAN 4.1.1 : Active & Inactive materials should be sampled from all the containers. 4.1.2 : Sugar is sampled by using squre root of n +1 formula where “n” is the number of the containers. 4.1.3 : The total quantity of material to be sampled is listed in attached index, which includes quantity required for analysis, and quantity required to be kept as control sample and microbiological analysis. 4.2 PREPARATORY WORK : 4.2.1 On receipt of GRN from stores, enter the details of the GRN into raw material inward register and allot the analytical reference No. (A.R.N o) 4.2.2 Check the GRN of the material to be sampled and if any entry is missing in GRN, get it rectified by stores personnel. 4.2.3 Record the observations on the sampling checklist. 4.2.4 Pre...

1.0 PURPOSE: This defines the procedure for testing, Approval & Rejection of all Raw material in Q.C. 2.0 SCOPE : It covers testing & approval/rejection of all Raw materials. 3.0 RESPONSIBILITY : Applicable to all Quality control & Quality assurance staff 4.0 PROCEDURE : 4.1 On receipt of sampled raw materials, required quantity shall be taken for analysis as per the respective specification. Remaining quantity is stored as Control Sample. 4.2 Identification test should be carried out for all the individual containers sampled ( for Actives). 4.3 Batch wise analysis shall be carried out as per specification on the pooled sample for the remaining tests (Actives as well as Excipients). 4.4 All raw materials are tested as per the Raw material specification. 4.5 After analysis reports shall be prepared by Chemists. Checked by Asst. Manager/Executives, approved / rejected as per the results, by Manager - Q.C 4.6 The GRNs shall be approved / rejected by stamping with “PASSED” or “...

1.0 PURPOSE: To provide a procedure for Preparation and Authorisation of specifications. 2.0 SCOPE: To make available specifications for RM / PM / Inprocess and Finished Products 3.0 RESPONSIBILITY: Executive-Quality Control 4.0. ACCOUNTABILITY: Manager- Quality Control 5.0. DEFINITIONS: 5.1. Specification is a authorised document describing the statutory requirements are prepared with reference of Pharmacopoeias or In-house parameters. 5.2. Release Specification: A document describing in detail In-house requirements( which have requirements additional to statutory requirements and limits of certain quality parameters more stringent than the statutory limits) with which the Intermediate product and finished product has to comply. 6.0. PROCEDURE: 6.1. There should be an authorised and dated specifications for raw materials and packing materials, intermediate, bulk and finished products 6.2. Specifications should be based on IP, BP, USP or In-house methods 6.3. Specific...

1.0. PURPOSE: To provide a procedure for Preparation and Authorisation of Test Procedures 2.0. SCOPE: To make available specifications for RM / PM / Inprocess and Finished Products 3.0. RESPONSIBILITY: Quality control Chemist 4.0. ACCOUNTABILITY: Manager- Quality Control 5.0. DEFINITIONS: Standard test procedures are prepared for various General analytical test which includes Qualitative and Quantitative analysis. 6.0. PROCEDURE: 6.1. There should be an authorised and dated Standard Test Procedures for all raw materials and packing materials, intermediate, bulk and finished products. 6.2. STP should be based on IP, BP, USP or In-house methods. 6.3. STPs are made based on Pharmacopoes, manuals and other Reference books. 6.4. Standard Test Procedures are developed and approved by Manager-QA, Authorised by Manager –QC. 7.0. REFERENCES: PHARMACOPOEIA IP/BP/USP 8.0. ENCLOSURES: Nil 9.0. ABBREVIATIONS: STP-Standard Test Procedure

1.0. PURPOSE: To provide a procedure for Qualification Protocol for QC Instruments. 2.0. SCOPE : The procedure covers all the instruments used in the quality control department. 3.0. RESPONSIBILITY : Executive-Quality Control 4.0. ACCOUNTABILITY: Manager-Quality Control 5.0. DEFINITON: Nil 6.0. PROCEDURE: 6.1. Protocol on validation should be prepared for installation of any new equipment or instrument. 6.2. Protocol should describe the following points 6.2.1. Name of the instrument 6.2.2. Code No. of the instrument 6.2.3. Instrument manufactured by/ supplied by. a) Catalogue No. b) Serial No. c) Size of instrument( Height x Length x breadth) d) Supply of power by AC/DC 6.2.4. Validation/Calibration required 6.2.5. Frequency of Validation/ Calibration. 6.2.6. Installation and Validation report 6.3. Instruments must be validated depending on its purpose and use. 6.4. Protocol will give information for preventive maintenance. 6.5. It should be documented in case o...

1.0. PURPOSE: To provide a procedure for the action to be taken in the event of out of Calibration of instruments. 2.0. SCOPE: Applicable to all the QC instruments 3.0. RESPONSIBILITY: 3.1. Quality Control Chemist 3.2. Maintenance Engineer 4.0. ACCOUNTABILITY: Manager-Quality Control 5.0. DEFINITION: 6.0. PROCEDURE: Following actions should be taken in the event of out of calibration status of instruments. 6.1. Inform the head of the QC department and affix a status label 'OUT OF CALIBRATION' 6.2. Inform the Maintenance department to carry out in house rectification of the instrument. 6.3. If the in-house maintenance department can rectify the defect, then use the instrument after proper calibration. 6.4. In case in-house maintenance department is unable to rectify the defect, call the supplier / manufacturer of the instrument. 6.5. Once the said instrument is repaired then carry out calibration and ensure that it is working satisfactorily. 6.6. If t...

1.0. PURPOSE: To provide a procedure for Stability study. 1.1. To gain a thorough understanding of any chemical and physical changes and microbiological changes to which the formulations may be exposed during the shelf life under different storage conditions. 1.2. To confirm that our formulations are stable and satisfactory in marketed pack through out the cycle of ware housing distribution , storage and use. 1.3. To recommend storage conditions, retest periods and shelf life. 1.4. To monitor any impact of changes in manufacturing process and its impact on product quality on long term storage . 2.0. SCOPE: To assign responsibility for the preparation & control of Batch record. 3.0. RESPONSIBILTY: Quality Control Chemist 4.0. Accountability: Manager -QC 5.0. Definition: NIL 6.0. PROCEDURE: 6.1. Stability study sample to be kept in marketed pack or similar to the marketed pack. e.g. Blister pack and Bulk pack. 6.2. If a product is more than one pack , stability st...

1.0. PURPOSE: To lay down guidelines for training of new entrants and periodic retraining of technical staff. 2.0. SCOPE: To define role/responsibility of various functions responsible for technical training. 3.0. RESPONSIBILITY: 3.1. Corporate Managers 3.2. Departmental Manager(Qualified Trainer 3.1 Overall responsibility to assess the training needs and ensure that training is conducted as per the annual schedule with QA. 3.2 Unit QA Manager shall give cGMP training with help from Corporate QA. 3.3 The Unit QC manager with the help of Corporate manager Quality Control shall give GLP training. 3.4 Unit Production manager shall give technical training for the staff and the operators of Production department with the help of President- Technical. 3.5 Workmen training for both technical and basic rules of GMP shall be done in 'vernacular' language by respective supervisory staff on periodic basis. 3.6 Training should be conducted by a qualified trainer. 3.7 Co...

1.0. PURPOSE: This procedure gives guidelines of identification, collection, indexing, filing, access, storage, maintenance and disposition of Quality control records, including label controls of under test, approved, rejected labels and calculation sheets. 2.0. SCOPE: Covers all the documents generated under quality system. 3.0. RESPONSIBILITY: QC Chemists 4.0. ACCOUNTABILITY: Manager-QC 5.0. DEFINITION: Nil 6.0. PROCEDURE: 6.1. The records created during the operation of the Quality system, identified, as Quality records shall be legible, securely identifiable and retrievable. They may be in the form of printed modes of magnetic media. 6.2. The releasing authority shall be responsible for maintenance, storage, retrievability and disposal of Quality records. 6.3. The Quality records shall be made available for evaluation to customer or his representation in case of contractual obligation. 6.4. List of Quality records stored with their location and retention period ...

1. Objective: To lay down a standard procedure for Exit from Sterile Area. 2. Scope: This procedure provides a standard guidelines to Exit from sterile Area. 3. Responsibility: ¯ Operator. ¯ Supervisor - Production. ¯ Senior Chemist. ¯ Head - Production. 4. Procedure: 4.1. In the third air lock remove the surgical gloves and keep it in the respective S.S Vessel containing disinfectant solution. 4.2. Enter into the second air lock; leave the slipper & sterile dress into a plastic dress bin for washing. 4.3. Enter into the first air lock wear the usual dress and exit.

1. Objective: To lay down a standard procedure for destruction of the rejected ampoules / vials. 2. Scope: Filled glass vials and ampoules which are rejected need to be periodically destroyed under proper supervision using the standard procedure. 3. Responsibility: ¯ Operator. ¯ Production supervisor. ¯ Head - Production. 4. Procedure: 4.1. Obtain the necessary authorization for destruction where ever applicable. 4.2. Check the labels on the bulk containers holding the vials / ampoules to be destroyed. 4.3. If the vials / ampoules to be destroyed are individually labeled and packed, then de-pack the vials / ampoules from the shippers and de-label these vials / ampoules by soaking them in a tub containing water and remove the labels. 4.4. De-seal each individual vial using a de-sealer and remove the stopper from each vial / ampoule. 4.5. Collect the contents of each vial / ampoule in a suitable container by emptying each vial. 4.6. Discard the collected ...

1. Objective: To lay down a standard procedure for Sterile Dress Washing and Sterilization. 2. Scope: This procedure provides standard guidelines for Sterile Dress Washing and Sterilization. 3. Responsibility: ¯ Supervisor - House keeping. ¯ Chemist – Production. ¯ Head – Production. 4. Procedure: 4.1. Put the Sterile dress to be washed and sterilized, in plastic dress bin. 4.2. Washed with detergent powder followed by water. Finally washed with 0.1% Disinfectant. 4.3. Dry the washed dress in sun light and fold the dried dress. 4.4. Keep all the folded dress in SS Bins. Move the lid and keep open the holes. 4.5. Load the SS Bins into the Steam heat sterilizer and carry out the sterilization as per the standard procedure. 4.6. While unloading the box, keep close the holes by moving the lid. Then keep the dress bin in the second air lock which is ready for use.

1. Objective: To lay down a Standard procedure for Sterile Area Entry. 2. Scope: This procedure provides standard guidelines to enter into the sterile area. 3. Responsibility: ¯ Operator. ¯ Senior Chemist. ¯ Supervisor - Production. ¯ Head – Production. 4. Procedure: 4.1. In the first air lock remove the ordinary dress and slipper and keep neatly in the respective places, wash the hand and legs with soap solution followed by water. 4.2. Show the washed hands in front of Hand drier to dry. 4.3. Enter into the second air lock through cross over bench, wipe the hands with sterillium solution and wear the sterilized dress, sterile area slipper. 4.4. Enter into the third air lock, wear the sterilized gloves and walk on the germicidal mat containing disinfectant solution (dettol 5%). Note: The person who is entering into the sterile area should not have any infection and wounds.

1. Objective: To lay down a standard procedure for Sterile Area Disinfection 2. Scope: This procedure provides a standard method for routine cleaning of sterile area using Disinfectants to ensure the area is completely free from micro organisms. 3. Responsibility: · Senior Chemist - Production · Supervisor - Production. · House keeping 4. Procedure: 4.1. Remove all glass pieces if any, from sterile area after completion of the filling. 4.2. Clean the filling Machine, SS parts, filling table and floor with distilled water. 4.3. Use hot distilled water to remove the strain if present.Then use following disinfectants as per the schedule. 4.1. After cleaning, dry the sterile area for half an hour. 4.2. The Machine, table, laminar airflow should be wiped with decontaminating solution. Decontaminating solution contains: Liquid phenol 5% w/v Formaldehyde 8% v/v IPA 75% v/v Distilled water QS 4.3. Spray the hydrogen peroxide solution 20% w/v (Virosil Pharma) after cleaning and wiping. 4.4. Fin...

Objective To carry out the drying operation in an ordered sequence and to avoid untoward effects. Operating Procedure Note Check and certify that area and equipment are clean and suitable for starting the operation Ensure that main switch is in “OFF” position before dismantling FBD for loading Assembling Unclamp the fixing bolts of retarding chamber and allow it to rest on the trolley, take out the trolley along with the retarding chamber. Check and certify the suitability of the clean finger bag Fix the finger bag in a steel hanger, fix the loops of the finger to the hooks of the shaker Place the bag in between the retarding chamber and fluidization chamber. Clamp the retarding chamber on the body with fixing bolts Loading Load the bowl with material to be dried. Place the product uniformity in the bowl to avoid lumps Move the product bowl below the retarding chamber keeping the window in viewing p...

Objective To carry out the drying operation in proper manner and to avoid the cross contamination of the granules. Cleaning Materials Cleaning Agent : Water Cleaning equipment : lint free duster, nylon scrubber Method of Cleaning Procedure for Product to product change over Clean the body of the drier and plenum with a dry clean duster. Then wipe it with a duster soaked in 0.1% teepol solution followed by a duster soaked in water. Detach finger bag from hook by opening perplex windows in the retarding chamber Unclamp the fixing bolts of retarding chamber & allow it to rest on the trolley. Take out trolley along with the finger bag and retarding chamber. Remove the finger bag & bowel Dedust the individual finger chamber of finger bag & keep it in a polythene bag. Send it for laundering Take retarding chamber along with trolley and bowl with hot water scrubbing with clean nylon scrubber. ...

Objective To carry out the blending operation in a good condition, good operation procedure should be followed. Note Ensure that the “Cleaned and Ready for Use” status label is present on the equipment. During loading and unloading use gloves elbow size Operating Procedure Place the label containing the Name of the product, Batch No & Batch size over the equipment Adjust the angle of the blender with the help of moving wheel to a required position for convenience in loading of materials. Open the lid and load the materials from the container into the blender as per the sequence given in BMR, close the lid, put the safety pin on the lid by moving the wheel in clock wise direction. Caution : Put the safety guard before commencementof the operation. Cover the area below the blender with polybags. Switch ON the equipment & start the blending of material as per the time specified in the BMR After the completion of blending switch OFF the instrument Remove the poly bag and guard Adju...

Objective To carry out the mixing operation in a clean equipment according to the requirement of GMP. Cleaning Materials Cleaning agents : Tap water Cleaning equipments : Dry duster, 0.1% Teepol Caution Disconnect the equipment from electrical main supply Note Set the position of the blender vertical- butterfly value facing the floor. Cleaning Procedure (For Product to Product Change Over) Dismantle the safety guard of the blender, circular lid and gasket by unclamping the wing nuts Clean the outside of the blender with dry duster followed by moist duster and then with dry duster. Keep the butterly valve close and keep an SS container below it. Wash inside the blender with tab under and drain it through butterfly value Clean inside surface with warm water 40°C to 50°C followed by 0.1% teepol solution. Then wash with plenty of water to remo...

Before starting the granulator check that all the parts comes in contact with the product are clean and also see that the machine is free from the previous batch particles. Switch off the mains of the granulator and remove the old product labels. Detach all the pars which have come in contact with the product and take them to the washing area. Soak the mesh and other parts in water for about 15 minutes. Use a nylon brush to remove the particles adhering to the mesh. Clean the hopper, hopper lid, propeller and hopper ring with a plastic scrubber using 5 gms of Sodium Lauryl Sulphate solution in 1 litre of water as a cleaning agent. Clean the above parts with a jet and rinse them with purified water, finally dry them by using air blower. Clean the undetatchable parts with a nylon brush and wipe with wet cloth followed by dry cloth. Assemble the parts on to the machine and affix a label stating that the machine is “CLEAN” Check the oil in the gear box fortnightly and fill it with SAE ...

Objective It is essential to carry out the mixing operation in a clean equipment in order to avoid cross contamination. Note Ensure that the equipment is possessing ‘ TO BE CLEANED ‘status label. Make sure of that all the drums, drum cards, mixed and unmixed materials of the previous products are taken away from the section. Keep the power switch for the machine in “OFF” position and disconnect the power cord. Materials Required Cleaning agents : Tap Water, 0.1% Teepol. Cleaning Equipments : Lint free cloth, scrubber. Cleaning Method Dismantle the heart shaped beater from the central rod. Remove the bowl from the cradle wash the beater and bowls with flowing water to remove the powders / granules adering to their surfaces. Scrub the beater, the shaft holding the beater, the roof of the mixing chamber and the bowls with sponge using 0.1% Teepol. After scrubbing clean the scrubbed parts with pleanty of tap water. Vi...

Objective To remove any left over adhering powder thereby to avoid cross contamination. Materials required for cleaning Cleaning agent : DM water, tap water Cleaning of equipment : Muslin cloth, nylon brush Cleaning Procedure Switch OFF the power supply. Clean the lid with vessel of the mixer with the jet of tap water. Thoroughly wipe the outer portion of the machine with clean and dry cloth. The mixer is rinsed with hot tap water to remove adhered lumps of powder. Clean inside of the mass mixer with a jet of tap water till all the powder sticking is completely removed. Then use nylon brush for cleaning. Care should be taken that all the corners of the mixer and loaffles are thoroughly brushed & cleaned. Remove the water and rinse with fresh hot DM water and dry it by using clean muslin cloth. After getting approval from QC display “CLEANED” sta...

Objective To carry out the mixing operation in an orderly sequence and to eliminate any untoward effects. Operation Procedure Loading of Materials Load the materials from the containers / drums into the bowl as per the sequence specified in the Individual product BMR. Close the lid and lock the 3 locking clamps Operation Stick a card possessing the batch no, product name, batch size of the product to be mixed. Put the main switch ON The operator and other person involved in the manufacturing should wear clean hand gloves, head cap and nose mask. After all the required materials are loaded into the mass mixer, it is allowed to run for the required time as per the Individual product BMR Add the binder / paste – binder solution by opening the lid, then run the mixer to the required time as per the Individual product BMR Packing is done if required and mainly in the center of the bowl After the wet mixing, discharge the wet mass into the bowl by opening the d...

1. Open ‘B’ and ‘D’ and allow the raw water to pass through bed for 10 minutes. 2. Close ‘B’ and ‘D’. Allow the bed to settle for 10 minutes. 3. Preparation of Soda Solution Take 12 litres of D.M. water into the caustic tank, weigh and add 0.75 kgs of caustic soda into the tank under stirring. Ensure completely dissolved. 4. Soda Injection Fill regeneration tank used for regenerating purpose with 5 litres of soda solution. Connect the regenerant inlet and compressed air pipeline to the regenerant tank. Open E and G to allow the soda injection to take for 10 minutes by adjusting the air pressure. Close E and G. After soda injection close E and G and stop compressed air supply. 5. Soda Rinse Open E and G. Connnect regenerant inlet to raw water. Rinse for 20 minutes. Close E and G. 6. Preparation of Acid Solution Take 5.5 litres of D.M. water into the acid measuring tank, pour 1.8 litres of acid and stir to get uniformity. 7. Acid Injection F...

1. Preparation of Acid Solution Take 22 litres of D.M. Water into the acid measuring tank, pour 10 litres of acid and stir to get uniformity. 2. Preparation of Soda Solution Take 32 litres of D.M. Water into the caustic tank. Weigh and add 2.4 kg of caustic soda into the tank under stirring. Ensure completely dissolved. Allow the solution to get cooled before regeneration. 3. Acid Injection Fill the regenerant tank with 16 litres of Acid Solution. Connect the regenerant inlet and the compressed air pipeline to the regenerant tank. Open “B” to allow acid injection to take place for period of 15 minutes by adjusting the air pressure. Close ‘B’. Repeat the process by filling the regenerant tank with remaining 16 litres of acid solution and by opening ‘B’. After acid injection close ‘B’ and stop compressed air supply. 4. Acid Rinsing Connect the regenerant inlet to raw water supply. Open ‘B’ and rinse the resins for 20 minutes. Close ‘B’ 5. Before s...

1. Switch off conductivity indicator 2. Close all valves and pinchcocks including raw water supply. 3. Raise regenerant bag, lock in position and the open the lid. 4. Preparation of Acid solution Pour 6 litres of commercial grade Hydrochloric acid in anticorrosive container and 15 litres of D.M. water to dilute. 5. Acid Injection a. With all valves closed, disconnect raw water inlet tube and lead it to a drain. Pour 7 litres of the prepared acid solution into regenrant bag. Open valve B and pinchcock P2. b. Adjust flow of acid to drain by means of pinchcock P2 such that the flow is approximately 1 litre per minute. Repeat a) and b) till all the prepared solution is used. 6. Acid Downflow Rinse Pour 20 litres of D.M. Water in the regenerant bag in three lots. 7. Preparation of Soda Solution Dissolve 1.2 Kgs of caustic soda in 21 litres of D.M. water. After caustic soda is completely dissolved pour in the regenerant bag in three lots. ...

1. Ensure water fed to the softening plant is free from suspended particles, Iron, organics, oil, slime, heavy metals. 2 Regeneration of the softner plant is being done whenever the water quality detoriates, (confirm by test given below). 3 Regeneration: 3.1. Dissolve 10 kgs of commercial grade Sodium Chloride in about 60 Liters of raw water in water softner injection tank. 3.2. Back wash for 10 minutes with Raw Water 3.3 Inject the brine solution (Down flow) with the help of the Ejector. 3.4. Remove Calcium and magnesium salts formed during regeneration and excess brine by down ward flow of raw water. (Approximately 15 to 20 minutes) 3.5. Up-Rinse the softner for 15 to 20 minutes with raw water. 4. check the Quality of water by the following method.(Hardness less than 1mg/lit) following method. Take about 100 ml of soft water and pour it into a round bottom flask. Add 1 tablet of t...

1. Open the drain valve of the receiver tank, drain the water and close 2. Check oil level in the viewer. Ensure that the oil occupies not less then 50% in the viewer 3. Switch on the cool water pump. Ensure that the water pressure is between 2-3kgs/cm2 4. Put the main Switch ON. The light under “SEE POWER ON” will glow 5. Put the start button ON. The light Under “Running ON” will Glow 6. Put the remote in Automode 7. Press the “LAMP TEST” and confirm that light glows under the following headings. a. separator b. oil filter c. reverse rotation d. high sump pressure e. high discharging pressure f. motor over load g. low water pressure 8. During normal service if any of the indicator 9. During normal service sump pressure will be at 8Kgs/cm2 and on line pressure will be around 6.0Kgs 10. Unloading of the compressor will t...

1. Ensure: Quality of water. The hardness of water should not exceed the limit of 2PPM. 2. Ensure levels of LDO/Diesel & soft water in tanks. 3. Ensure steam temperature is set at –195°C. 4. Ensure drain valve of economizer, fuel strainer drain valve and coil blow down valve are closed. 5. Open control valves of water, LDO/diesel. 6. Put the electronic main switch ON. Observe the white control lamp comes ON. 7. Close main steam valve and open the auxiliary steam valve. 8. Put the Fill switch on to fill up the coil. 9. When the water starts coming out of the auxiliary steam valve, the unit is ready for firing. Ensure at this line that all the red lamps are off and only the white control lamp is on at this stage. 10. Press Fuel circulation switch for about half a minute so that Fuel pressure builds up to about 2kgs/SQ cm. 11. Put the fire switch on. Blower, Fuel Pump and water pump will start. 12. Ensure that the gre...

Object & Scope Identifying the basic characters of machine like capacity, power requirment,(voltage, / current) name of the make etc Problems Observed & Rectification Details Procedure History cards are maintained for each and every machines and equipments as per the enclosed format History card gives the performance of the machine (ie) types of problems observed, frequency, how it is rectified, the preventive maintenance to be taken to avoid the regular repeated problems. It also gives the idea about the reputability of the machines and equipments manufacturer (vendor Validation) HISTORY CARD CONTAINS THE FOLLOWING DETAILS Date Name of the Equipment: Capacity : Make : Voltage : Frame : Current : Speed : Date of Installation : Conn. : and Coloumns for the following for entering day to day date Date: Problem Observed Remedy Taken Remarks

Objective & Scope In order to maintain the machines and eqipments properly a team is formed with an engineer as a head with 3 technical persons as assistants Procedure 01. He will be reporting to works manager. 02. He is responsible for achieving total production target and reducing rejections within the norms 03. He should plan for a total preventive maintenance schedule for all the machineries and should see that it is implemented and followed up regularly at the required intervals and also proper records should be maintained. 04. He is also responsible for immediate rectification of all breakdowns, reducing down time of the machines to the barest minimum. 05. He is responsible for total inception, planning, procurement, erection and commissioning of new projects, which are being handed over to him from time to time. 06. He should try to develop spare parts indigenously or locally, thus reducing the high cost involved in the procur...

Object & Scope Maintenance of various essential utility equipments in good condition. Achieve good output and less maintenance expenses, by adopting the following procedures. The major equipments covered by the utility department are: 1. GENERATOR 2. BOILER 3. A.H.U. (AIR COMPRESSOR) 4. WATER TREATMENT (PUMPS, SOFTENER, D.M PLANT) 5. VARIOUS EQUIPMENTS IN PRODUCTION AREAS Procedure In order to maintain the machines and equipments in good condition the following SOP’s are adopted 1. Fixing Duties & Responsibilities Of Maintenance Engineer 2. Maintenance Of History Card For Machines And Equipments 3. Standard Operating Procedures For Machines 4. Preventive Maintenance Schedule Procedures For Machines And Equipments 5. Check List For P...

1. The Standard Operating Procedures should be numbered and dated. Suitable alphabetical prefix should be given in the numbering in order to indicate the department in which the document has been created. Following alphabetical prefixes are assigned to various departments The first LETTER shows G – General U – Utilities W – Water System MF – manufacturing Q - Quality Control / Quality Assurance The Next LETTER Shows subdivision of the main area BS - Building & surrounding H – Hygiene S – Sanitation SF – Safety Manual B - Boiler G - Generator A - AHU (Air handling unit) ...

Purpose: To describe the procedure for the preparation, implementation and control of Standard Operating Procedures Responsibility : Manager - QA, All Head of the Departments. Procedure A. General A Standard Operating Procedure (SOP) is a written approved procedure which describes how to perform a operation in a plant. It is not necessarily specific to a given material or product but is of a general nature. Standard Operating Procedure (SOPs) should be created in every department of the factory and should cover the various phases of a manufacturing operation and its control. They must list by steps what must be done and how it is to be done. B. Writing of SOP 1. Department Head will write the SOP and will submit to Manager - QA for approval. 2. The title should be clear and should indicate the nature and purpose of the document. 3. Where the procedure bears instru...

Procedure: As soon as the compression of a particular batch is used, transfer the punched goods to packing and disconnect the electrical supply to the machine and carefully dismantle the following parts. Feed hopper, Acrylic guards, feed frames, turret guards, corer plate of the worn shaft nylon break plugs along with the spray steel strips, die screws tablet collecting chutes dust collecting wood assemblies. Clean all the above mentioned parts along with relevant bolts thoroughly with hot tap water and keep them aside. Cleaning procedure for Punches, dies and machine : Remove carefully all the lower punches by removing the plug and keep these punches in a specially designed wooden tray, serially arranged, similarly remove all the upper punches and keep them in a separate wooden tray serially arranged, remove all the dies with the help of a SS rod and keep them serially arranged in one of the above trays. Clean the exterior po...

INTRODUCTION The sifter is used to sift the various excepients such as Starch, Talcum, Magnesium Stearate, Stearic Acid etc. It is also used to sift active materials also. Proper cleaning of the sifter at the end of sifting process ensures prevents of cross contamination. PROCEDURE As soon as the sifting process is over, dismantle the following parts: a. SS feed hopper b. SS frame, holding the sieve in place c. SS wire mesh sieve. 1. Remove all the residual powder adhering to the above mentioned articles with the help of a nylon brush. 2. Wash these articles with the help of running hot water. 3. Wash these articles with sponge using 0.1% TEEPOL. 4. Clean these articles with running hot water for at least 10 minutes to remove all traces of detergent. 5. Drain off all the water and dry all the articles with the help of a hot air blower. 6. Clean the exterior of the sifter stand and...