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FDA COMPLIANCE POLICY GUIDE Sec. 490.100 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval

Origin/Publisher:

Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/

Document Type:
Compliance Policy Guide (CPG)
Content:
This Compliance Policy Guide explains the enforcement policy on the timing of the completion of certain validation activities for drug manufacturing and API manufacturing.

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