A February 2022 FDA Warning Letter to Accu Bio-Chem Laboratories provides a great baseline for what your audit programs should look at and what your own labs should focus on:
- Handling of OOS results – 21 CFR 211.192
- Analytical Life Cycle Management (verification of test methods) – 21 CFR 211.165(e)
- Integrity of electronic data – 21 CFR 211.68(b)
Throw in a good lab instrument qualification review, and supplier/raw materials management, and you have a pretty solid program.
Investigations of a Dog 