The audit checklist summarizes production area procedures and documentation requirements across 45 questions. It addresses topics like standard operating procedures, cleaning processes, equipment validation, batch records, environmental monitoring, personnel qualifications, and process controls. The checklist is used to classify audit findings as conforming or needing corrective action to ensure GMP compliance in pharmaceutical manufacturing.
The audit checklist summarizes production area procedures and documentation requirements across 45 questions. It addresses topics like standard operating procedures, cleaning processes, equipment validation, batch records, environmental monitoring, personnel qualifications, and process controls. The checklist is used to classify audit findings as conforming or needing corrective action to ensure GMP compliance in pharmaceutical manufacturing.
The audit checklist summarizes production area procedures and documentation requirements across 45 questions. It addresses topics like standard operating procedures, cleaning processes, equipment validation, batch records, environmental monitoring, personnel qualifications, and process controls. The checklist is used to classify audit findings as conforming or needing corrective action to ensure GMP compliance in pharmaceutical manufacturing.
Are there sufficient key personnel to supervise assigned functions? 1. Production
Is a complete index and a complete
set of applicable SOPs available in the 2. Department , Is the set of SOPs correctly organized, according to the index ?
Is there gowning SOP for production
3. staff?
Are there written procedures (SOPs)
for cleaning and maintenance of 4. equipment and utensils and are they followed?
Are cleaning and sanitizing agents
validated and approved for use by 5. QC?
Master Formula (MF):
Does the MF adequately describe the 6. complete production process?
Is the MF up-to-date and approved
7. by QC/QA
Are time and temperature limits
established for the completion of 8. production phases?
Are all deviations from SOPs
documented and subject to review 9. by QA/QC for approval or corrective action?
Are there SOPs written and
approved for all manufacturing and 10. testing activities? Is there a system for reprocessing of unsatisfactory and returned products, 11. subject to prior approval by quality control?
Are there written records of
preparation of cleaning and 12. sanitizing solutions? re there specific procedures for cleaning of major equipment items? Do they include instructions as to 13. which parts of the machine require assemble and disassembly for cleaning? Are they followed? Select a major piece of equipment Examine the following records: 14. • Machine Duty Card • Cleaning Checklist Examine the record of the daily check of balances in the department Is it complete and accurately filled out 15. Are all results within the specifications If not, is there a record of implementation of corrective action Are all work areas clearly labeled 16. with name and batch number of the product being processed Are components handled in such a 17. manner as to prevent contamination Observe a work station during production of a batch. Are manufacturing instructions at hand? Are the instructions complete, 18. including special instructions if relevant? Are the instructions accurately followed? Are records and signatures made on real time? Examine the batch record for a batch 19. which is being processed Product ___________ Batch No.___________
Are any in process results within the
20. defined limits Is all relevant information included, complete and accurately filled in as follows: Raw Materials Weighing Manufacturing Method Yield Reconciliation 21. In-Process Tests Packaging Standard Packaging Control Laboratory Results Manufacturing Deviation Report (MDR), if applicable Is yield calculation performed after each distinct phase of production granulation 22. compression coating blistering Packaging Is the yield calculation verified by a 23. second individual Is there documented evidence of line 24. clearance where required? Examine records of air pressure, temperature and relative humidity for the 25. last month. Do they meet the specifications stated in the relevant SOP? Are any deviations recorded together 26. with corrective action taken? According to the relevant SOP? Is there an approved annual program 27. for validation of all production equipment and critical systems? Whether all personnel prior to employment have undergone medical examination including eye 28. examination and all free from Tuberculosis, skin and other communicable or contagious diseases Whether proper uniforms and adequate facilities for personal cleanliness are provided. 29. Pls specify nature and type of dress used by the personnel in various areas of operation. What measures has been taken to prevent mix-ups during various 30. stages of production.
Is a validation performed to confirm
31. cleaning effectiveness?
Do the flow of cleaned equipment
32. through the washing room don’t allow re contamination? Are there gauges to detect pressure 33. differentials? Is there a record? Are the walls, floors and ceiling 34. surfaces smooth and easy to clean? For fluid bed dryers: is there a set of sleeves for each product, or is there 35. a cleaning validation process that guarantees no cross-contamination? Is the air injected in the coating 36. equipment filtered? Is it included in the preventive maintenance plan? Are the filters used in filtration of 37. liquid disposable? Are the changes recorded? Do bottles receive some type of 38. cleaning &on line with before filling? Are process controls performed at 39. each production step? Are there flow charts showing the 40. production steps and identify critical points? Is there a SOP dealing with the use of proper clothing for other persons who enter production areas 41. (technical service/maintenance, cleaning personnel, quality control inspectors, quality assurance inspectors, and visitors)?
Is the printed information resistant to
42. fading or erasing? Is there an area or sector for the 43. washing of containers and/or tools? Is the IPC room with calibrated 44. needed instruments? Are reprocessing and reworking previously authorized by 45. Control/Quality Assurance & done in accordance with a SOP?