Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products: Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
February 25, 2008
May 6, 2020
74ac14c8-579f-4c16-8e6c-a9f6c3bbdcdd
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