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With over twenty different official regulatory statements worldwide on Good Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the most influential and most frequently referenced.
Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans the most important substance from the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP guide, 2002). The author uses his 40+ years of experience in technical management, production, quality assurance, and distribution within the pharmaceutical industry, offering a hands-on guide to better understand and implement optimal pharmaceutical practices.
This book also compares the principle requirements of GMP, and explores the reasoning behind these requirements and ways to comply with them. Relevant topics include personnel, documentation, premises and equipment, production, quality control, self-inspection, recalls, and more. This is an essential guidebook for those who wish to expand their pharmaceutical business in any international capacity.
- Sales Rank: #1204880 in Books
- Brand: Brand: CRC Press
- Published on: 2004-10-15
- Original language: English
- Number of items: 1
- Dimensions: 10.30" h x 1.28" w x 7.16" l, 2.35 pounds
- Binding: Hardcover
- 520 pages
- Used Book in Good Condition
Review
…provides a pleasantly different approach to the destination of GMP compliance….represents a superb no-nonsense approach to the subject matter and will maintain its value well into the future.
-European Journal of Parenteral and Pharmaceutical Sciences
…gives an immediate and good overview of the differences and similarities between the US and EU interpretation of…how to deal with Good Manufacturing Practices.
--GMP Review
Most helpful customer reviews
0 of 0 people found the following review helpful.
Used for Graduate Classes
By G. C.
This book is required for my graduate class. It does provide useful information and important considerations with regards to GMP. It talks about the practical application of GMP in some detail. The only thing I don't like is that it seems to ramble on in perhaps too much detail. Sometimes the author over emphasizes a point. It sort of becomes very dry and hard to follow. I think the content could be pared down to be more concise. Otherwise though, this book is pretty straight-forward and useful as a reference text.
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