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How to Validate a Pharmaceutical Process
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There have been many books written about utility and equipment qualification as well as process validation. All of these books and articles describe the technical inner workings of the various pieces of process equipment or systems. These are helpful, but they do not tell you how to move forward from there. In performing a complete process validation program it is important to not only know what to do or what not to do but also to know why you are doing it. Thus, the goal of this book is to lead you through the workings of a successful process validation program. It includes those aspects of the surrounding operations that are necessary to complete the validation and attain full compliance to the Food and Drug Administration (FDA) Current Good Manufacturing Practices (CGMP) as found in the Code of Federal Regulations (CFR) Title 21 Parts 210 and 211. |
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2017-07-06 17:22:59, 6.12 M
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继续顶起46楼2022-08-15 15:39:12
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ycw101445楼
2022-08-15 15:38
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五星好评 顶一下，感谢分享！