Month: February 2021

OOS failures

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.

Upcoming Data Integrity Virtual Presentation

I will be presenting at the February Audit SIG of the DFW Section of the ASQ on Data Integrity.  Many companies struggle with the concepts of data integrity as it involves both paper and electronic data, dealing with legacy computer systems and the organization culture. This session will lay out the core principles of data integrity:

  • Organizational culture should drive ALCOA
  • Data governance is part of the management review process
  • Data Risk Assessments with appropriate mitigations (full risk management approach)

The Audit SIG webinar is scheduled for Tuesday February 9, 2021 at 6:00 pm.  To sign up RSVP to jcapstick@gramercyinc.net by February 8 by 6:00 pm.  An email with a link to the webinar will be returned to those that RSVP.