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Lab GMP Audits

Laboratory Audits

Quality Control (QC) lab audits are technically demanding in addition to concerns about GMP compliance. The laboratory auditor must be aware of the peculiarities of the laboratory and how to audit for technical competence as well as regulatory compliance. The experts at Microbiology Network have decades of experience in these audits, both internal company laboratories and external contract laboratories. Using the latest and most relevant guidance from USP, FDA and PIC/S for these audits, our audit team will work with your company to determine your audit needs and execute them in a timely and fiscally responsible manner. 

The base documents for these audits include USP <1117> Best Microbiology Laboratory Practices, PIC/S Aide Memoire on Audits of Analytical Laboratories, and relevant FDA guidance.  In addition (as appropriate):

  • 21 CFR 211
  • 21 CFR 820
  • 21 CFR 111
  • CTFA Quality Assurance Guidelines & CTFA Microbiology Guidelines

While conducting these audits, use the Microbiology Network consultants to train your internal audit team on how to look for issues in the laboratory environment. The competent lab audit goes far beyond the CFR to prepare your lab personnel for investigations, method reviews and best current practice. Use the QC Laboratory GMP Audit to benchmark your lab facility and provide the basis for a targeted training program.

Laboratory Investigations

The first question in any potential OOS (Out of Specification) investigation involving a microbiological test result has to be “Can we trust the data?” Use the experts at Microbiology Network to perform an in-depth investigation of the lab data behind finished product test failures, environmental monitoring or other laboratory data deviations. We wrote the book on the topic and can provide you valuable insight into your lab operations while training your QC lab management in effective investigation techniques.