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FDA Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories, July 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 microbiological QC laboratories. This guide supplements the Guide to Inspection of Pharmaceutical Quality Control Laboratories of July 1993 and goes into greater depth about the points an FDA inspector should check and inquire about in a microbiological laboratory.

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