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FDA Guide to Inspections of High Purity Water Systems, 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 water systems both for purified water and for water for injection (WFI). From the microbiological point of view they deal especially with the evaluation of water treatment systems, technical issues and the validation of water systems.

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