Method Development with a View to Quality Control

Phast GmbH, Biomedizinisches Zentrum, Homburg/Saar, Germany 

IMPLEMENTATION OF USP METHODS FOR A U.S.-LISTED FORMULATION OUTSIDE THE UNITED STATES 

All FDA-approved drugs products must meet the quality requirements described in the U.S. Pharmacopeia (USP) (1,2). If a drug product is to be manufactured elsewhere in the world but marketed in the United States, compliance with existing USP-NF monographs is crucial. Non-compliance may result in the FDA blocking entry of the product into the U.S. market or removing the product from the market. For other markets compliance with USP standards is not binding. For 

Sometimes certain aspects of the dissolution test suggested by the USP are not suitable for a particular drug 

This acceptance scheme describes a stepwise procedure. If each of the six dosage units initially tested shows a dissolution rate of not less than Q + 5%, the test has passed at Stage 

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Dissolution Method Development with a View to Quality Control... 

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