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To ensure quality of the Product
To assess effectiveness of QA system.
It established high degree of confidence.
It permits timely correction of problems.
6
Internal Audit
External Audit
Regulatory Audit
Product Audit
Process Audit
System Audit 7
8
9
10
11
12
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4)Product Audit:
• An in-depth examination of a particular product to evaluate
whether it conforms to product specification, performance,
standards, and customer requirements.
5)Process Audit :
• An analysis of elements of a process and appraisal of
completeness, correctness of condition and probable
effectiveness.
6)System Audit :
• A documented activity perform to verify, by examination
and evalution of objective evidence, that applicable
elements of the quality system are suitable and have been
developed, documented and effectively implemented in
accordance with GMP. 15
16
17
18
19
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Quality Audit plan and reports

  • 1. 1
  • 2. 2
  • 3. 3
  • 4. 4
  • 5. 5
  • 6. To ensure quality of the Product To assess effectiveness of QA system. It established high degree of confidence. It permits timely correction of problems. 6
  • 7. Internal Audit External Audit Regulatory Audit Product Audit Process Audit System Audit 7
  • 8. 8
  • 9. 9
  • 10. 10
  • 11. 11
  • 12. 12
  • 13. 13
  • 14. 14
  • 15. 4)Product Audit: • An in-depth examination of a particular product to evaluate whether it conforms to product specification, performance, standards, and customer requirements. 5)Process Audit : • An analysis of elements of a process and appraisal of completeness, correctness of condition and probable effectiveness. 6)System Audit : • A documented activity perform to verify, by examination and evalution of objective evidence, that applicable elements of the quality system are suitable and have been developed, documented and effectively implemented in accordance with GMP. 15
  • 16. 16
  • 17. 17
  • 18. 18
  • 19. 19
  • 20. 20
  • 21. 21
  • 22. 22
  • 23. 23
  • 24. 24