(585) 594-8273
info@microbiol.org

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.

Let's Talk

Put our network of GMP and Contamination control experts to work for your consulting or training needs.

 Download vCard     

What our clients say...
Frank Settineri is an outstanding microbiologist, packing more than 30 years of down-in-the-laboratory-trenches experience and wisdom that enables him to provide countless clients, friends, peers, et al. a bounteous amoung of advice on nearly every topic within microbiology. Frank is ever aware that...

Robert S
Schering-Plough

Microbiology Lists
MicroNet Blog

Check back frequently for new additions to the MicroNet Blog service.

Recent entries:

  1. BET Assay Interferences and Their Impact on Endotoxin Recovery
  2. Custom Microbiology Dictionaries
  3. Draft Revision to Antimicrobial Effectiveness Test Released by USP
  4. The Compendial Sterility Tests
  5. Alphabet Soup: Abbreviations and Acronyms of Interest
  6. The Compendial Draft Chapter on "Bioburden Control of Nonsterile Drug Substances and Products"
  7. A New Draft Guidance on FDA Expectations for Cosmetic GMP
  8. QC Microbiology and Social Media - A Microbiology Network Survey
  9. FDA Shuts down almost 1,700 Online Pharmacies
  10. Current Regulatory Enforcement Trends in Dietary Supplements
  11. Bioburden Contamination Control for Non-steriles – How Much is Enough?
  12. Pharmaceutical Compounding

  

Follow Microbiology Network, Inc.
on LinkedIn

 

Twitter Followers

Follow us on Twitter - @MicrobiologyNet

Visit our Twitter page for more information on Twitter in Microbiology