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FDA Guide to Inspections of Dosage Form Drug Manufacturers, October 1993

Origin/Publisher:

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

Document Type:
FDA Guide to Inspection
Content:
These guidelines of ORA within FDA are not addressed to the industry but to the FDA inspectors. The Guides to Inspection are, however, a useful aid. Here you will find guidelines for the inspection of pharmaceutical manufacturers. These guidelines concretize and interpret the fundamental American GMP requirements of 21 CFR Part 211. The investigator will find out how to implement the CFR requirements in an inspection.

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