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GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry

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GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry

4.85 32,600 ratings · 2,940 reviews
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Overview: As manufacturing and distribution practices get more complex and more global, manufacturers cannot just focus on one or two sets of requirements - it is too difficult to operate a quality system that has a multitude of variations to meet the individual requirements of a particular national authority. Most multinational firms and those supplying global markets have done what national authorities have not - they have created quality systems and quality system elements that internally harmonize GMP expectations. While there still are some unique requirements that need to be met, having a majority of requirements harmonized reduces duplication and increases flexibility. GMP in Practice, 4th Edition is intended to help with that harmonization. It contains more than 30 elements that are typically included in a modern pharmaceutical quality system. Each quality system element has an overview section, some risk-related questions, and 3-10 expectations. Each expectation is explored in a bit more detail and examples from GMP references from the US FDA, Health Canada, the European Union, the World Health Organization, and the International Conference on Harmonization (ICH) are presented. In order to get a rich understand of GMP, a person needs to have knowledge of what various national authorities expect. This book is designed to help you achieve this goal.

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Book details & editions

ISBN
15699101
Publisher
Davis Healthcare International Publishing
Publication date
January 1, 2011
Language
En-US
Pages
605 pages
Reading Options
PDF · EPUB · Mobi
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James L. Vesper
About the Author
James L. Vesper
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James L. Vesper is a writer and avid reader based in the Pacific Northwest. Before pursuing writing full-time, they spent over a decade working in education. When not working on their next book, James L. Vesper can usually be found hiking with their dog or trying out new coffee shops in their neighborhood.

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Exceeded all my expectations. It strikes a perfect harmony of dialogue and world-building. Every chapter felt necessary. I will undoubtedly revisit this masterpiece.
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Exceeded all my expectations. The author orchestrated a breathtaking finale. Truly a work of art. An effortless 5 stars.
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Masterpiece from start to finish. I adored how the story unfolded. It kept me captivated without sacrificing elegance. Worth every moment spent reading.
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