Practical Process Validation
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Language: en
Pages: 129
Pages: 129
Type: BOOK - Published: 2016-07-14 - Publisher: Quality Press
For the past decade, process validation issues ranked within the top six of Food and Drug Administration (FDA) form 483 observation findings issued each year. T
Language: en
Pages: 418
Pages: 418
Type: BOOK - Published: 2006-03-06 - Publisher: John Wiley & Sons
Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calcu
Language: en
Pages: 219
Pages: 219
Type: BOOK - Published: 2016-06-07 - Publisher: Academic Press
How to Validate a Pharmaceutical Process provides a "how to approach to developing and implementing a sustainable pharmaceutical process validation program. The
Language: en
Pages: 489
Pages: 489
Type: BOOK - Published: 2012-05-23 - Publisher: Academic Press
Designed to provide a comprehensive, step-by-step approach to organic process research and development in the pharmaceutical, fine chemical, and agricultural ch
Language: en
Pages: 535
Pages: 535
Type: BOOK - Published: 2012-05-09 - Publisher: CRC Press
Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes di
