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PREAPPROVAL INSPECTION GUIDE FOR TOPICAL PRODUCTS

 

The inspection of a manufacturer of topical products presents some basic issues that warrant discussion.  Issues that have presented problems include potency and assurance that a topical product has the labeled claim potency, that the active is uniformly distributed, that the product has satisfactory physical characteristics, and that the product is free from objectionable microbiological and chemical contamination.  This publication will discuss one of the major problems recently identified in the inspection of topical products.  Because of the increasing number of new transdermal manufacturers, it will include a discussion of transdermal products and unique problems specific to this topical dosage form.

 

 

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