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