The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Program 7356.002F Active Pharmaceutical Ingredients (APIs)

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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