Read GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry

GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry

James L. Vesper

4.9/5 (26000 ratings)

Description: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.We have made it easy for you to find a PDF Ebooks without any digging. And by having access to our ebooks online or by storing it on your computer, you have convenient answers with GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry. To get started finding GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry, you are right to find our website which has a comprehensive collection of manuals listed.
Our library is the biggest of these that have literally hundreds of thousands of different products represented.

Pages: 605

Format: PDF, EPUB & Kindle Edition

Publisher: Davis Healthcare International Publishing

Release: 2011

ISBN: 1933722541

Description: 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.We have made it easy for you to find a PDF Ebooks without any digging. And by having access to our ebooks online or by storing it on your computer, you have convenient answers with GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry. To get started finding GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry, you are right to find our website which has a comprehensive collection of manuals listed.
Our library is the biggest of these that have literally hundreds of thousands of different products represented.

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GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry

GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry

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