FDA Program 7356.002F Active Pharmaceutical Ingredients (APIs)

Title:
FDA Program 7356.002F Active Pharmaceutical Ingredients (APIs)

https://www.gmp-compliance.org/files/guidemgr/Bulk Pharmaceutical Chemicals 7356-002f-CDER.pdf

Origin/Publisher:

FDA

Document Type:
COMPLIANCE PROGRAM GUIDANCE MANUAL
Content:
FDA expects API manufacturers to apply CGMPs to the API process. This Guidance Manual contains specific FDA requirements.

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