Luis Collazo-Malave, Author at Lachman Consultant Services, Inc.

To Average or Not to Average, That is the Question?

By Luis Collazo-Malave and Mrinmoy Nag Sep 30, 2022 Compliance FDA OOS Regulatory Affairs

Earlier this year, we posted about FDA’s new revision for the OOS Guidance for Industry. The new revision allows ‘averaging’ results from a pool of replicate results even though one of them is OOS for ‘certain circumstances.’ This was the most significant change in this revision. So the question is, can you always average? If […]

May

Revision of OOS Results Guidance Provides Current FDA Thinking and Expectations

By Luis Collazo-Malave and Mrinmoy Nag May 25, 2022 Compliance FDA OOS Regulatory Affairs Science & Technology

In today’s blog, we want to create awareness that, after sixteen years, in May of 2022, the FDA has finally announced revisions to the 2006 guidance “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production. (here). Specifically, this revision updates terminology for consistency with current FDA guidance, e.g., the quality control unit “QCU” is changed to the […]

To Average or Not to Average, That is the Question?

Revision of OOS Results Guidance Provides Current FDA Thinking and Expectations

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