Go and read the January 2021 FDA warning letter to Allay Pharmaceuticals and then go and read the 1993 decision in United States vs Barr Laboratories.
The Barr decision, issued 28 years ago, explains how to deal with OOS results. The FDA followed up with a guidance in 2006 “Guidance for Industry Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.” Companies have no excuse for continued failure here, and yet as we see with Allay (and so many others) failures in investigation of out-of-specifications continues to be a major concern. Yet nothing we see is not covered in the Barr decision.
If you a pharmaceutical GMP professional these three documents should be ones you are more than ready to explain against your quality system.
2 thoughts on “OOS failures”