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FDA Guide to Inspections of Oral Solid Dosage Forms Pre/Post Approval Issues for Development and Validation, January 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 FDA inspectors. The Guides to Inspection are, however, a useful aid. Here you will find guidelines for the inspection of manufacturers of solid oral dosage forms. This document addresses many problems in the validation of solid dosage forms. It distinguishes between prospective and retrospective validation. This guideline also deals with the inofficially required Product Development Report and lists the information that should be given therein. The advantages and disadvantages of some actual mixer types are also dealt with.

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