Good manufacturing practices for pharmaceuticals  a plan for total quality control from manufacturer to consumer

Good manufacturing practices for pharmaceuticals a plan for total quality control from manufacturer to consumer

Author
Joseph D. Nally
Publisher
M. Dekker
Language
English
Year
2000
ISBN
978-0824704254
File Type
pdf
File Size
12.8 MiB

Highlighting key issues and differences among GMPs of Europe, Canada, and the WHO, this reference examines US law and governmental policy affecting domestic and multinational pharmaceutical manufacturing. The book recommend pragmatic ways to interpret and comply with FDA CGMP regulation and related criteria. They focus on geographical redistribution of manufacturing facilities, accommodation of a diversity of regulatory and statutory governance, adaptation to disparate human resources, and new growth areas of manufacture and distribution of homeopathic remedies and dietary supplements, in addition to the greater quality control required of pharmacists and other authorized dispensers.

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