Aseptic Pharmaceutical Manufacturing II, Groves

Автор: Burdick
Название: Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry
ISBN: 3319501844 ISBN-13(EAN): 9783319501840
Издательство: Springer
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Цена: 11878.00 р.
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Описание: This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities.

Автор: Leblanc Destin A
Название: Validated Cleaning Technologies For Pharmaceutical Manufacturing
ISBN: 1574911163 ISBN-13(EAN): 9781574911169
Издательство: Taylor&Francis
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Цена: 33686.00 р.
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Описание: Written by an expert especially for those who must design validatable cleaning processes and then must validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more defensible in both internal quality audits and external regulatory audits. Designed for use in the overall validation program, the book demonstrates how to build a comprehensive program, and includes discussion and examples of cleaning systems, regulatory requirements, and special topics and issues. It provides an FDA cleaning validation guidance document and a comprehensive glossary.