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PHARMACEUTICAL EQUIPMENT VALIDATION
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FDA regulations, such as Current Good Manufacturing Practice (cGMP) for pharmaceuticals, Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and industry standard ISO 9000, require that documentation, such as protocols, be established and followed. These regulations do not provide guidelines on how specifically to produce the documentation. It is left up to individual companies to design their own validation documentation system. This book provides hands-on techniques for qualifying pharmaceutical equipment to achieve FDA compliance. This book is designed for individuals responsible for writing and executing qualification protocols for drug products and for related industries, such as drug devices and diagnostics, pharmaceutical biotechnology, and bulk pharmaceutical chemicals. This book provides a complete set of 38 protocol templates. These templates are different because they are already filled in, thus providing answers to many of your protocol writing and testing questions. Simple diagrams and other graphics illustrate key ideas. The author's personal experience with various regulators, such as FDA, FAA, NASA, and Explosives, Firearms & Tobacco, influenced the decision to write this book. The need came from always wanting to know exactly how to do something and the regulators' not providing it. The methods described in this book are those of the author and are not to be construed as the policy of his employer. v |
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2015-08-19 20:06:24, 7.02 M
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60楼2015-12-28 14:23:47
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pingshan2楼
2015-08-19 21:08
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2015-08-20 07:47
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