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FDA Guide to Inspections of Topical Drug Products, 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. You will find here guidelines for the inspection of manufacturers of topical forms (emulsions, creams, ointments). Topics addressed are: uniformity of active substance content, equipment for production, cleaning validation, microbiological controls, change control and transdermal topical products.

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