Regulatory Affairs Meeting the U.S. Food and Drug Administration FDA Requirements

REGULATORY AFFAIRS MEETING THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) REQUIREMENTS 

Our objective is to have you build quality into your drugs, not test it in. 

The Management of Chemical Process Development in the Pharmaceutical Industry by Derek Walker Copyright 2008 John Wiley Sons, Inc. 

Examples from the drug product area and from the API production area illustrate the continuing need for vigilance. 

Another case, much more serious and also more pertinent to the chemical process development area, occurred in 1989 when over 1600 people became ill with eosinophilia-myalgia syndrome (EMS) and 38 died, worldwide, after taking l-tryptophan (Trp) manufactured by one producer in Japan. Prior to the outbreak, this producer whose Trp met the 98.5% purity specification had decided to employ a new genetically modified strain of the established Bacillus amyloliquefaciens and also to halve the amount of activated charcoal used in the purification step. These changes cause the Trp product to become contaminated with several new impurities, principally I to III, all associated to some extent (using a crude animal model) with EMS.5 

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