Processing Controls to be followed During Manufacturing of Drug Products

Procedure to be followed (But Not Limited to ):

  1. Access to the Manufacturing Area is restricted to Authorized personnel only
  2. All personnel entering the Drug Product Facility shall follow the gowning Procedure mentioned in the SOP   Procedure for Entry and Exit from Change  room to Process and Packaging Area.
  3. Before entering the process area, the personnel shall understand the responsibilities of their positions and individuals entering inside the manufacturing area are responsible for themselves and others to follow the Current Good manufacturing practices rules and regulation.
  4. Personnel Who have an apparent illness or open lesion that may adversely affect the quality of a material or product must be prevented from direct contact and shall not be allowed to enter the process area, until the condition is recovered.
  5. Persons who are sick shall not be allowed to enter in the process area. They shall be examined by the registered medical practitioner and must be certified fit and only then they shall be allowed inside the process area.
  6. Visitors shall be allowed only after authorization from the area in-charge and they shall always be accompanied inside the manufacturing area by company employee.
  7. Where raw materials, active pharmaceutical ingredients (API) and intermediate, finished products are exposed, personnel must remove all unsecured jewellery and other objects that may fall off and must take adequate precautions to secure watches, identity tags or other loose items.
  8. Clean protective garments must be worn when working with or near exposed raw materials, API and in-process materials.
  9. When wearing the garments checks that the garment is clean and no loose threads and or damage is observed.
  10. Personnel working in areas and with processes where intermediate products is exposed must wear gloves and must cover excessive facial hair (beards, moustaches, side-burns, etc.).
  11. All personnel involved in manufacturing operations must wear personal protective equipment appropriate to the need to protect these materials from contamination.
  12. Inside the production area, there must be no eating, chewing, smoking, drinking or keeping of plants, food, drinks, smoking materials and personal medicines in any production areas.
  13. There must be no direct contact  between a person’s ungloved  hand or any other unprotected body part and a material, API, in-process materials or a primary packaging component or equipment product contact surface.
  14. Inside the production area, unnecessary personnel movement in the corridors is restricted.
  15. Before starting the operation, environmental conditions such as Temperature, Relative Humidity and Differential Pressure shall be checked as per the respective product batch record. The operation shall be continued if the environment conditions are within the acceptance limit, else the information shall be given to the Concerned person to take necessary action.
  16. Ensure that all lights of the room are working. In case any tube light is not working, get it rectified. 
  17. Inside one processing room only one batch of the product shall be processed.
  18. Ensure that all the equipment, containers and rooms shall bear the dully filled labels as appropriate.
  19. Ensure the Cleanliness of the area and the equipment before starting the operation. If a new batch is to be started, then get the equipment/ room/line clearance from QA.
  20. Weighing balances shall be verified on prior to use as per the respective SOP and recorded in Balance verification record before starting the weighing operation.
  21. All steps during process shall be strictly followed as per the written instructions in Batch manufacturing record and respective Standard Operating Procedures.
  22. All the in-process checks during the process shall be done as per the specified frequency mentioned in the respective batch record.
  23. All entries of time in Equipment Log book, Batch record and all GMP related documents shall be done on 24 hours time basis. The date shall be entered in DD/MM/YY or DD/MM/YYYY format.
  24. All the Reject bins and Waste bins shall be kept with properly labeled as per the respective SOPs.  Rejects and Waste bins shall be emptied and cleaned on daily basis.
  25. The Area / Equipment which is under maintenance shall have the maintenance label duly signed by the Engineering.
  26. Online entries shall be made in respective documents with permanent Blue ink pen. Correction of wrong entry on the document shall be carried out by striking off with the single line .After cancelation and necessary correction the concerned person shall put the sign and date with justification. The reason such as entry error, calculation error, printing error, transcription error, typographical error etc. can be used as applicable and as suitable.
  27. All materials, containers, equipment shall be labeled for identification and status at all stages.
  28. Intermediate (tablets & capsules) and finished product shall be stored in a double poly lined High-Density Polyethylene containers and shall be labeled both inside and outside the container.
  29. Process area floors, walls and ceilings shall be subjected to a regular cleaning and sanitation as per the respective SOP at specified frequency interval.
  30. Drug Product in all stages such as starting material, Intermediate and Finished Product shall be stored in the respective designated area after completion of activity.
  31. At the end of the shift or at the end of the day, equipment power supply, room lights shall be switched off to save energy.
  32. Before closing the operation for the day, all product containers shall be closed properly and transferred to respective quarantine which is maintained at controlled temperature.
  33. All keys shall be placed in the key board of the production office. The key of the key board shall be with the area in charge.  
  34. All containers of a batch shall be stored on pallets and all shall be stretch wrapped.
  35. No container shall be opened in the quarantine area for any reason. If the container needs to be opened for sampling or any other purpose, it shall be done in non-operational clean room. The line clearance shall be taken from IPQA and shall be recorded in the batch manufacturing record.
  36. Pest control activities shall not be carried out inside the warehouse, manufacturing, packaging, quality control labs and change rooms.
  37. After Cleaning of SS Bin, check the outer surface of SS Bin visually and check internal corners of the SS Bin and other difficult area to see, with the help of ‘Mirror’ and ‘Torch’.
  38. Nylon brush/scrubber and lint free cloth which are used for cleaning of equipment’s and area are for single use. Discards these cleaning aids after cleaning of the equipment/area.   

Pl refer

Pl refer


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