ORAL DOSAGE FORM SOPs

1.0 PURPOSE

To provide a procedure for entry and exit of all personnel into the manufacturing and primary packing area.

2.0 SCOPE:

This procedure is applicable to entry and exit procedures of all personnel into the manufacturing.

5.0 PROCEDURE:

5.1 Entry procedure to Production and Ware house department.

5.1.1    Enter the factory through the main gate and complete the preliminary security checks done at security block.

5.1.2    Enter the room designated as “Campus dress change room” through respective entrance provided    for gents and ladies.

5.1.3    Deposit all the personal belongings including bangles, wrist watches, rings, chains in a locker   provided.

5.1.4    Remove the street footwear followed by street dress and keep in each designated lockers.

5.1.5    Collect and wear the factory uniform and factory foot wear.

5.2 Entry procedure into Manufacturing, Primary packing area

5.2.1    Open the main door and enter the change room through respective entrance provided for gents and ladies and Visitor change room.

5.2.2    Enter the respective change room, remove the factory foot wear and keep it in a designated place.

5.2.3    Enter into hands and foot wash room.

5.2.4    Wash the hands using and water followed by washing of foot and stand on mats provided.

5.2.5    Dry the hands and foot using the drier provided.

5.2.6    Open the door of primary change room and enter.

5.2.7    Sit on the cross over bench and cross over.

5.2.8    First wear the footwear provided and then wear dedicated primary uniforms,

5.2.9    Check the attire in the mirror provided.

5.2.10   Disinfect the hand with disinfectant (such as 70% v/v IPA) and enter the common corridor.

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1.0 PURPOSE

To provide procedure for Visitors entry to and exit from manufacturing, dispensing, sampling, secondary packing and warehouse area.

2.0 SCOPE:

This procedure is applicable to entry and exit procedures for visitors in manufacturing area.

5.0 PROCEDURE:

5.1 Enter the factory through the main gate and complete the preliminary security checks done at security block.

5.2 Report to reception.

5.3 Entry procedure for visitors into warehouse and secondary packing area.

5.3.1 Enter the visitors change room.

5.3.2 Remove the Blazer, hat or some external wear and keep it in a S.S rack provided.

5.3.3 Sit on the cross over bench provided and cross over.

5.3.4 Collect the visitors dress, shoes cover and disposable cap.

5.3.5 After collection of visitor dress check the flow diagram for better clarity.

5.3.6 Wear the visitors dress and disposable cap.

5.3.7 Sit on cross over bench, wear shoes covers on footwear and cross over the bench.

5.3.8 Check attire in mirror provided.

5.3.9 Disinfect the hands with disinfectant (such as 70% v/v IPA).

5.3.10 Open the door and enter the corridor.

5.3.11 Enter secondary packing and warehouse area.

5.4 Entry procedure for visitors into manufacturing and dispensing area.

5.4.1 Enter secondary change room.

5.4.2 Wear disposable pant and nose mask.

5.4.3 Sit on cross over bench, wear shoe cover on foot wear and cross over the bench.

5.4.4 Check the attire in the mirror provided.

5.4.5 Disinfect the hands with disinfectant (such as 70% v/v IPA) and enter the corridor.

5.4.5 Enter to manufacturing and dispensing area.

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1.0 PURPOSE

To provide procedure for usage of in-process labels in warehouse, manufacturing and packaging area.

2.0 SCOPE:

This procedure is applicable to usage of in-process labels in warehouse, manufacturing and packaging area.

5.0 PROCEDURE:

5.1 Check the requirement of labelling for the equipments, accessories and product containers.

5.2 Select appropriate labels for the respective activity/ area/ equipment/ container/ product as required.

5.3 Ensure cleanliness of the product holding containers / crates and transfer to the processing cubicle.

5.4  Check the cleanliness of the container / crate and sign on the respective label.

5.5  Affix on container / crate, inform QA for cleanliness verification.

5.6 QA person shall verify the cleanliness of container / crate and sign on the respective label.

5.7 Store the product into the container / crate and update the product details.

5.8  Affix the status label for the respective stage i.e. unlubricated / lubricated / compressed / coated / filled hard gelatine capsules on the label.

5.9  Indicate the next stage by filling the ‘STATUS’ column on the label

5.10 Insert one label between the poly bags of the container and another label to be affixed to the container. During next stage of process affix to BMR

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1.0 PURPOSE

To provide procedure for recording data in log books used in store, manufacturing and packaging area.    

2.0 SCOPE:

This work instruction is applicable to recording data in log books used in warehouse, manufacturing and packaging area.

5.0 PROCEDURE:

5.1 Receive the required log books from QA.

5.2 QA person shell Issue Log books required for production and store at the beginning of every calendar year or as required during the year for new equipments, additional log book to continue from the completed log books.

5.3 After completion of the log book, QA person shell issue new log book and record the issuance date by confirming in the log book of the same year.

5.4 Place the respective area and equipments log books for recording details.

5.5 Following are the types of logbooks used in production, packaging and store

5.6 Check the date, time and environmental parameters like Temperature, RH and pressure differential, as applicable using calibrated instruments and record in the respective log book. Recording of the parameter should be preferably done during the beginning of the shift or beginning of the activity and signed off, to be updated after the completion of activity or end of the shift.

5.7     Record area cleaning and usage details in the respective area log book.

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1.0 PURPOSE

To provide procedure for storage of dispensed RM, intermediate and semi-finished product in   manufacturing.

2.0 SCOPE:

This procedure is applicable to storage of intermediate and semi-finished product in manufacturing department.

5.0 PROCEDURE:

5.1       HANDLING AND STORAGE OF RM:

5.1.1    Store dispensed RM in respective day store.

5.1.2    On completion of Dispensing activity, check and receive the material from warehouse required for production and store in Day store as required.

5.1.3    Enter the receipt details in the day store log book as applicable and maintain the day store under lock & key.

5.1.4    On the day of processing verify the dispense materials with BMR for gross weight, batch no/lot No. & material. Then transfer to respective manufacturing area under the supervision of production executive and update the day store log book and status board (wherever applicable).

5.1.5    Additional Raw material requisition / Raw Material requisition, Additional Packing material/ packing material requisition shall be initiated in respective formats, if required. The reason for initiating this can be, but not limited to process loss / through deviation if any/ on line material rejections. / to complete the unit operation etc.

5.1.6    Record the reason for initiating the Additional material requisition in remarks column. Take department head approval.

5.1.7    Check and review the reason for the requisition and approve.

5.1.8    Take approval by Head QA / his designee and authorization by plant head or /his designee.

5.1.9    On receipt of Additional material requisition, verify the completeness of the respective requisition and carry out the dispensing activity.

5.1.10   Material return note shall be initiated in respective format, the reason for initiating this can be, but not limited to dispense materials which are not used / change in Manufacturing / Packaging plan, left over material etc. the same shall be returned to stores with appropriate status labeling.

5.1.11   Check and review the reason for the material return and approve.

5.1.12   On receipt of material return note, check the completeness and verify the details against physical quantity of materials returned.

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1.0 PURPOSE

To provide procedure for management of accessories in manufacturing and Packaging.

2.0 SCOPE:

This procedure is applicable to management of accessories like sieves, screens, flexible and S.S       hoses, cage / hydraulic trolleys, pallets and change parts in manufacturing and Packaging.

5.0 PROCEDURE:

5.1 Procurement of accessories (like sieves & screens, FBD bags, change parts and other accessories required for manufacturing and Packaging area) is shall be done by respective department through purchase department as per the requirement by checking the stock, requirement for operations and if any new or replacement of defected / Rejected are required with detailed specification.

5.2  The accessories are checked and received from stores department.

5.3  The accessories are stored in designated place.

5.4  In case of sieves & screens follow the below mentioned procedure​

5.5  Receipt and identification number of new screens and sieves:

5.5.1 On receipt of the sieves and screens, check the same and verify all details against delivery challan / indent.

e.g. For Tablet Department 20# Size Sieves: T / 40 # / 01 / 20

Y: T for Tablet Department

XX: Two digits indicate for Size of Screen/Sieves e.g. 40 size sieve should be marked as 40#.

MM: Two digits indicate for Number of Screen/Sieves e.g. two 40 # sieves are available means for first sieve Numbering should be 01, second should be 02 and further new 40 # screen should be marked as 03.

ZZ: Last two digits indicate last two digits of year of receipt e.g. 40# received in 2024 means should be marked as 24.

5.6     Cleaning and calibration of new sieves and screens:

5.6.1  Prepare 5 liters of 5% of 0.1N HCL (45ml HCL in 5 liters of Water). Clean the Sieve/ Screen by dipping in 5% HCL and remove any metallic and adhering particles.

5.6.2  Clean with raw water and 2% v/v S.L.S solution by using a nylon scrubber. Clean it with sufficient quantity of raw water till no foam is observed in rinse water.

5.6.3  Finally rinse each sieve and screen with purified water and dry till free from moisture in drying room.

5.6.4  Enter the cleaning detail in Screen and sieves initial cleaning & calibration record of respective sieves / screen and labeled as ‘Cleaned’ ready for calibration.   

5.6.5  Check for the correctness of sieve by using Linear Mesh Calibrator e.g. For 20 # sieves, count the number of holes in 1 square inch area of sieves for randomly selected different 3 locations by using Linear Mesh Calibrator and in case of screen randomly check 3 diameters of holes by using Illuminated Scale – Magnifier.     

5.6.6  Enter the result in Screen and sieves initial cleaning & calibration record of respective sieves and screen records.

5.6.7  Check for the integrity of entire sieves by using. In case of screen visually check integrity against light. If found satisfactory, enter Screen and sieves initial cleaning & calibration record of respective Sieves and Screens.

5.6.8  Record with label stated as ‘CLEANED’, and store in a poly bag at designated place.

5.7     Usage / periodic integrity checks of sieves and screens:

5.7.1  On the day of the usage remove the screens/ sieve and check integrity/ sagging. If integrity is damaged, do not use the sieve or screen. Record the observations in the respective Sieves / Screens Periodic observation for integrity test format.

5.7.2  Before and after the process is completed, check the integrity of the sieve / screen. If damaged, do not use it.

5.7.3  Enter the observations in the BMR and address through deviation. Additionally check the integrity of all the screens and sieves once in a two month as per the procedure and record in Sieves / Screens Periodic observation for integrity test format.

5.8     Regular cleaning and storage of sieves and screens:

5.8.1  After the activity is completed, remove the sieve/ screen and check for integrity and put in to poly bag with ‘TO BE CLEANED’ label and transfer to washing area.

5.8.2  Soak the screen and sieve in raw water for 10 minutes and clean it with raw water to remove adhering particles followed by scrubbing with nylon scrubber with 2% v/v S.L.S solution. Rinse with sufficient quantity of raw water till the rinse water is free from foam.

5.8.3  Rinse with purified water and dry in the drying room. Check the integrity by holding against the light.

5.8.4  If found satisfactory, put cleaned Sieves and Screens in poly bag cover. Close the poly bag and affix the “CLEANED” label.

5.8.5  Store all the cleaned Sieves and Screens in its designated place.

5.8.6  Visually check for cleanliness and if required, once again clean before use.

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1.0 PURPOSE

To provide procedure for management of FBD bags and Vent bags.

2.0 SCOPE

This procedure is applicable to management of FBD bags and Vent bags.

5.0 PROCEDURE:

5.1 Receipt, cleaning and storage of new filter bag and vent bag:

5.1.1 Receive the bag from the supplier through stores and review for its correctness against the requirement.

5.1.2 Check the bag visually for any loose stitching, absence of holes, improper stitching etc. If any defect is observed get rectified /replaced based on the criticality of defect

5.1.3 Label the new bag with product name or identification number by embroidering or by any suitable means the Non -product contact area.​

5.1.4 Soak in sufficient Luke warm water for about 10 minutes. Invert the fingers of the fluid bed drier filter bag and scrub gently

5.1.5 Dip the filter bags / vent bag in 2% v/v Detergent solution for about 10 minutes.

5.1.6 Drain the water and rinse the bag with sufficient water till it is free from detergent solution. (Identified by absence of foam) and drain the water

5.1.7 Rinse the filter bag / vent bag with purified water.

5.2 Procedure for sanitization of FBD/vent bag using GRAMICID solution [500PPM]:

5.2.1 Composition of Gramicid [48% w/w Hydrogen peroxide, 500ppm Silver and PW water q.s]

5.2.2    Fill approximately 50 liters of purified water in a clean suitable SS vessel.

5.2.3    Take 25g or 21.55ml Gramicid and add to the water present in SS vessel and gently mix.

5.2.4    Soak the clean and rinsed FBD and vent bag in the solution for 15minutes.

5.2.5    Drain out the solution from the SS vessel.

5.2.6    Rinse the FBD and vent bag with purified water twice.

5.2.7    Transfer the sanitized filter bag and vent bag into a labeled polythene bag and bring it to the respective granulation area.

5.2.8    Dry in fluid bed drier by keeping the inlet temperature at 750C ± 50C until it dries completely (Approximately 30 to 45 minutes).

5.2.9    Issue a new log card and enter the details of the filter bag in the log card.

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1.0 PURPOSE:

To provide procedure for cleaning of production area and Warehouse.

2.0 SCOPE:

This work instruction is applicable to cleaning of production area and Warehouse

5.0 PROCEDURE:

5.1 DISINFECTANT PREPARATION

5.1.1 Below is the list of disinfectants to be used, their recommended concentration.

5.1.2 Dilute the measured quantity of disinfectant / cleaning agent in a dedicated clean container up to the required volume by using purified water (PUW) as per requirement.

5.1.3 If the concentration of undiluted stock changes, then change the initial quantities of stock and water to get  desired final concentration.

5.1.4  Label the preparation with name of solution, preparation, expiry date, and the concentration prepared as per labelling SOP.

5.1.5  Make the entries in the respective log sheets as per area of cleaning.

5.1.6  Always use freshly prepared disinfectant solutions for floor, wall and ceiling cleaning according to above table.

5.1.7  After finishing the cleaning, clean the containers, mops, measuring cylinders and other accessories used for solution preparation with sufficient quantity of purified water, wipe them with lint free cloth and store them in designated place in inverted condition to drain off any residual water.

5.1.8  When cleaning of ceiling, wall and floor is involved on the same day, clean ceiling first followed by wall and at the last clean the floor.

5.1.9  While cleaning the change rooms and production facilities, give priority to clean the production area first then clean the change rooms.

5.1.10  Use two bucket system, where one bucket will be always dedicated for clean solution storage and another bucket will be always used for dirty cleaning solution storage during cleaning   process.

5.1.11 Always use dedicated containers like measuring cylinders, beakers, buckets etc. for the preparation and use of disinfectant solutions. Label all the containers and do not mix them with the other containers used in the process..

5.1.12  After completion of cleaning, record the name of disinfectant used and area cleaning status in respective attachments as per area classification.

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1.0 PURPOSE: 

To provide systematic approach of Risk Assessment, Identification, Evaluation, Control, and Review of the possible of cross contamination in manufacturing process cycle of the drug product manufacturing.

2.0 SCOPE:

 This work instruction is applicable to provide procedure for control and monitoring of cross contamination in Production Department.         

5.0 PROCEDURE:

5.1  PRE-REQUISITE AND INSTRUCTIONS:

5.1.1      Follow the written procedures at every stage of processing of product and its materials / equipment / personnel movements & during manufacturing operations to avoid possible contaminations or cross contaminations.

5.1.2    Personnel’s entering to the manufacturing area shall be properly understand detailed gowning procedure and strictly follow the practices.

5.1.3    Personnel working in the manufacturing areas where contamination is a ‘hazard’ like processing areas where highly active, highly toxic and dust generating powder materials are handled shall be given with specific instructions and shall take necessary precautions and perform the activity to avoid possible contamination or cross contaminations.   

5.1.4    Any unhygienic practice within the manufacturing areas where the product might be adversely affected shall be forbidden.

5.1.5    Personnel handling the manufacturing operations shall be properly understand the orderly and logically positioning of materials / intermediate / bulk product storage to avoid the mix up’s.

5.1.6    Wherever possible follow closed system of manufacturing operation to avoid the unnecessary exposure of materials.

5.1.7    Continuously monitor and record the process on-line in all manufacturing operation.

5.1.8    Contamination from one product to another product arising from the product residues on the gowns: The procedure to be followed for personnel movements to the production area.

5.2  PERSONNEL ENTRY AND EXIT PROCEDURE FOR PRODUCTION AREA:

5.2.1    Report any adverse health conditions that might affect product quality and fill the health report record.

5.2.2    Follow the respective area SOP while entering and exit from production area.

5.2.3    Only authorized personnel of the respective area are allowed to handle the manufacturing activity.

5.2.4    Restrict /minimize Personnel movement from processing area to corridor. Clean gowns before moving out of processing area to corridor.

5.2.5    Do not move from allotted processing area to another processing area without the authorization of shift executive /Department Head.

5.2.6    During breaks / at shift end go directly to respective change rooms and do not enter any other processing areas.

5.2.7    Perform the gowning and de gowning in gentle manner so as to avoid movement of product residues in the change room environment.

5.2.8    Personnel of Production / IPQA / Engineering / QC / Housekeeping / Visiting staff entering to and exit from multiple cubicles shall follow all instructions mentioned in the respective area SOP.

5.2.9    Preferably Visitors not be taken into the core production areas. If required, give information particularly about personal hygiene, cross contamination measures and the protective clothing.

5.2.10  Wear the hand gloves and required personnel protective equipments like 3M nose mask, safety goggles, ear plugs etc. As per product requirement. 

5.2.11  Keep the tidy and intact attire (personnel gowns) in the manufacturing area.

5.2.12  Change the Personnel uniforms after every product to product change over.

5.2.13  In the event of hand gloves is torn out during processing, immediately stop the activity, dispose and wear the fresh hand gloves to continue the further.

5.2.14  Contamination from one product to another product arising from the product residues in the processing area: The below mentioned procedures to be followed for cleaning the production area.

5.2.15  Ensure the production area is cleaned as per standard procedure before starting the activity.

5.2.16  Verify the cleanliness of area for :Cleanliness of area, walls/ ceilings , hood of the dust extractor pipe, all the service lines, SOP plates, document holders, doors, vision panels, door hinges, door closures,  tables, switch boards, sockets, PLC board, printers and printer cabinets exterior portion of grills of AHU. Cleanliness of floors / Drains. Ensure the cleanliness of balance platform (wherever applicable).

5.2.17  Obtain necessary line clearance as per standard line clearance procedure.

5.3       CONTAMINATION CONTROLS OVER MATERIAL MOVEMENT:

5.3.1    Controls over Handling of dispensed raw material to manufacturing from warehouse: The below mentioned procedures to be followed while handling the materials from warehouse to manufacturing area.

5.3.2    Once material transfer is completed along with associated documentation, counter check the material dispensed against dispensing sheet.

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1.0 PURPOSE:

 To provide procedure for cleaning of equipment and accessories in manufacturing.

2.0 SCOPE:

This procedure is applicable to cleaning of area, equipment and accessories in manufacturing at Production Department.

5.0 PROCEDURE:

5.1  Non serial cleaning procedure (Type-B cleaning):

5.1.1  Type-B cleaning frequency: Cleaning during changeover of different products with different active ingredients, colour, descending potency, post maintenance of product contact parts, when the next product is not known.

5.1.2    Perform Type-B cleaning during campaign batches manufacturing activity after every three days.

5.1.3    In case of Type –B cleaning, transfer any container containing semi-finished product to the respective area after affixing a duly filled “IN-PROCESS STATUS” label.

5.1.4    Affix the “TO BE CLEANED” label for equipments which are to be cleaned and transfer them to   “equipments to be cleaned” area covered with polythene cover or stretch wrap as applicable.

5.1.5    In case of any rejected product waste shall be transferred to the product waste bin provided.

5.1.6    Clean the equipment / accessories with raw water internally as well as externally till it is free from detergent.

5.1.7    Follow the cleaning procedure of equipment as per the respective work instructions. For other equipment / accessories, (non-product contact), scrub the equipments with 2% v/v of S.L.S solution & scrubber. 

5.1.8    Wash with raw water till free from detergent, ensure by absence of foam in water.

5.1.9    Finally rinse the product contact parts, with Purified Water.

5.1.10  Dry the equipments in drying room till free from water droplets. Wipe the equipment/accessories with clean dry lint free cloth.

5.1.11  Fill the equipment specific cleaning checklist if applicable, in accordance with the procedure specified. The annexure shall be having diagrams overleaf the checklists (page 2 of 2 of all checklists) indicating the ‘Difficult to Clean’ parts, and referred from respective cleaning validation documents, and hence not included in the annexure in this procedure.

5.1.12  Visually inspect all listed parts as mentioned in the checklist of the respective equipment after the cleaning.

5.1.13  After satisfactory cleaning of equipment and filling of checklist at this stage hand over the checklist along with BMR to production supervisor.

5.1.14  Affix ‘CLEANED’ label with the relevant details on the cleaned equipment.

5.1.15  Re-inspect the machine visually and upon satisfactory verification of machine and its parts, fill the checklist in appropriate section and retain along with respective product BMR and notify QA for further verification.

5.1.16  Visually inspect the equipment in dis-assembled state for cleanliness and based on satisfactory verification sign-off the checklist.

5.1.17  Enclose the filled checklist with the respective product BMR/BPR. Store the equipments / accessories in the designated place by covering in polybag or stretch wrap.

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