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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