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FDA Guide to Inspections of Oral Solutions and Suspensions, August 1994


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
These guidelines of ORA within FDA are not addressed to the industry but to the inspectors of FDA. The Guides to Inspection are, however, a useful aid. Here you will find guidelines for the inspection of manufacturers of liquid oral preparations and suspensions. The following topics are addressed therein: premises and equipment, requirements for starting materials, manufacturing methods, microbial quality, homogeneity of suspensions, specifications, stability, packaging and process validation.

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