Auditing Your Microbiology Laboratory - Webinar CD/Transcript
Auditing Your Microbiology Laboratory: Ensuring Decontamination to Regulatory Standards
With several high-profile sterilization incidents over the last several years making headlines, warning letters for sterilization have increased dramatically, showing that this is a major area of concern for the FDA.
But when it comes to auditing a microbiology lab, background and experience in microbiology itself, while valuable, won’t be sufficient by itself to satisfy the FDA.
Instead, Holistic GMP compliance knowledge and experience, familiarity with publicized microbiological laboratory failure modes/quality breakdowns, “war stories (e.g., inspection findings),” and properly comprehensive audit planning and organization are necessary and sufficient for fulfilling the regulatory agencies' expectations of this highly important combination compliance-and-quality audit.
This presenation will focus on the topics a proper microbiology lab audit covers as well as how auditors obtain evidence.
You will learn how an auditor or a regulatory agency investigator thinks, and the “trails” they follow. This knowledge will help you and your company make continual improvements of the microbiology laboratory, its equipment, documents, records, personnel, etc. and become and remain forever audit-friendly.
Areas Covered include:
- Sampling, sample control, and chain-of-custody
- Employee training
- Contract services — Qualifying them and reviewing/monitoring their performance and results
- Method validation, tech transfer, inter-laboratory comparison testing of unknowns (e.g., for certification)
- Chemical reagents and media (critical laboratory reagents) — their sourcing and quality control
- Reference standards and control cultures
- Equipment and instruments and their qualification, calibration, and maintenance
- Document control and record keeping
- Laboratory controls (i.e., laboratory design/set-up, appearance, environmental controls, ongoing activities)
- Non-sterile product testing for total bioburden, specified as well as objectionable microorganisms
- Sterility testing and sterility test isolators
- Biological endotoxin testing (BET) via LAL
- Environmental monitoring
- Microorganism (environmental) isolates identification and library
- Microbiological data deviations (OOSS specific to microbiology lab tests)