US FDA in its guidelines on good manufacturing practices 21 CFR Part 10. Have clearly mentioned that a pharmaceutical company should have its procedure to conduct internal audit. While providing the guidance on internal audit in pharmaceutical manufacturing company it has mentioned that the audit team should comprise of personnel from quality assurance and the person with knowledge of manufacturing of the dosage form, personnel from engineering department.
If any pharmaceutical manufacturing company fail to conduct internal audit, it is considered as it has not followed the US FDA guidelines, guidelines state that they are not mandatory, but in event of noncompliance to the gmp guidelines, the product manufactured in such facility is termed as spurious and adulterated and of substandard quality, even if the product meets its required purity and assay and quality attributes.
This is why the following the good manufacturing practices guidelines is important part of the pharmaceutical manufacturing. Internal audit is the part of gmp guidelines and it should be done meticulously.
During internal audit many nonconformance are noticed which can be corrected which ensured that the product manufactured will have better quality.
How to do internal audit? Which points to check during internal Audit in a Pharmaceutical Manufacturing company?
Past audit report should be referred before conducting the internal audit. CAPA implemented during the internal audits should be verified during the audit, if they can be challenged with challenge test for their effectiveness should be verified. Market complaints and their root causes identified, their CAPA should be verified.
Following points if taken in internal audits prove very helpful.
1. Effectiveness of training of personnel to carry the critical work.
2. Personnel Hygiene
3. Entry and exit procedure and its effectiveness.
4. Facility surrounding cleanness.
5. Gowning procedure 6. PPE practices. 7.Opening and closing of the department.
6. Environmental monitoring and Cleaning and Disinfection procedure.
7. Deviations and their root causes, their CAPA.
8. Change controls their implementations and closures, pending Change controls for implementation.
9. Validation and revalidation Status.
10. Validation Master plan for future plan on Validation.
11. Cleaning validations.
12. Equipment Qualifications.
13. Calibrations and routine verifications of equipment balances and analytical instruments.
14. Preventive maintainace schedule.
15. AHU cleaning and maintainace, Profiler cleaning and maintainace.
16. Sanitization record. Fumigation practices.
17. Unit operations. Observe any operation in manufacturing and verify against the written instructions if it is followed as per written procedure.
18. Challenge test for Equipment, like Camera inspection system, Checkweigher, Metal Detectors., Checker validation (Individual checker).
19. Password protection system electronic records audit trails and log books.
20. Lux level in the critical area as well as in surrounding premises.
21. Risk assessment
22. Electronic sensors challenge tests.23 Standard operating Procedures. 24. Filtration systems..
There are many points one can verify during the internal audit in pharma manufacturing company.
What to do on the nonconformance and suggestions for improvisation?
The nonconformance should be discussed in the management reviews immediately after internal audit and the respective nonconformance should be addressed through Planed or unplanned Deviation or Incidence, Change control or CAPA.
After implementation of CAPA the similar nonconformance must not repeat.
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