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EU and FDA GMP regulations: overview and comparison

✍ Scribed by John G. Grazal; David S. Earl

Publisher
John Wiley and Sons
Year
1997
Tongue
English
Weight
112 KB
Volume
2
Category
Article
ISSN
1087-8378

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✦ Synopsis

The increasing emphasis on global supply of drug products, as well as starting materials and investigational materials, along with international agreements between regulatory authorities, requires Quality Professionals to be versed in the GMP requirements of other nations. In particular, knowledge of both EU and US GMPs is becoming a necessary aspect of doing business in today's market. The foundations of the EU and US GMP systems, an overview comparison of drug product GMP regulations and a summary of the status of regulations is presented.

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