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FDA Guide to Inspections of Sterile Drug Substance Manufacturers, July 1994
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 manufacturers of sterile active ingredients. For sterile active ingredients the general active ingredients guidelines, which are supplemented here by specific requirements for sterile active ingredients, also apply.
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