What The FDA Doesn’t Tell You About OOS Investigations for Raw Materials

The FDA guidance “Investigating Out-Of-Specification (OOS) Test Results for Pharmaceutical Production Guidance for Industry” (May 2022) (here) applies to APIs and other raw materials, as well as finished products, but does not address specific considerations for APIs and excipients.  Here at Lachman, we work with manufacturers of multiple product types and have the following advice […]

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

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 […]

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Revision of OOS Results Guidance Provides Current FDA Thinking and Expectations

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 […]

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