Performing Credible GMP Audits

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The purpose of a Pharmaceutical QMS GMP Audit is to achieve three separate goals; to ensure the QMS meets requirements, to make sure it is effectively implemented and to provide a means for continuous improvement. None of these goals can be obtained if the GMP Audits are under some type of suspicion. 

Suspicion may be the result of any number of sources, but one of the most common is the feeling that the GMP Audit might not be objective. In a recent GMP Auditor training class, two participants from the same company indicated their reason for wanting to be an GMP Auditor is so they could “get Joe!” Although their comments were in jest (at least we hope so), even joking can put a cloud of doubt over the entire GMP Audit process. That is not to say we can’t have fun, but we must be judicious about what we joke about, when we joke, and who is around.

Of course, performing credible GMP Audits goes much farther than just saying things in jest. In order to perform a credible GMP Audit, three attributes must be present.

  • GMP Audits must be accurate
  • GMP Audits must be impartial
  • GMP Audits must be meaningful