Lyophilization Process : A Guide to Process Validation

Language: English

Published by LAP LAMBERT Academic Publishing, 2019

3659789682 / 9783659789687

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Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH

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nach der Bestellung gedruckt Neuware - Printed after ordering - Process validation is a requirement of the Current Good Manufacturing Practices Regulations for Finished Pharmaceuticals, 21 CFR Parts 210 and 211, and of the Good Manufacturing Practice Regulations for Medical Devices, 21 CFR Part 820, and therefore, is applicable to the manufacture of pharmaceuticals and medical devices. Lyophilization is an essential component of synthesis and formulation processes in chemical and pharmaceutical industry. Therefore, it is needed to be validation and per regulatory requirements. Successful process validation programs begin with a thoughtful and comprehensive corporate policy concerning the process validation program. This policy should recognize that process validation begins at the initial stages of development, and does not end until the lifetime of the product is over. It is important that all employees be fully trained and understand their role in the program. Good science, well-documented development programs, proactive procedures and definitions, and well-written protocols will increase the chances of successful process validation.

Seller Inventory # 9783659789687

Title
Lyophilization Process : A Guide to Process Validation
Author
Surendra Swarnkar
Publisher
LAP LAMBERT Academic Publishing
Publication year
2019
Condition
Neu
Binding
Taschenbuch
Language
English
ISBN 10
3659789682
ISBN 13
9783659789687
Item weight
161 grams
Dimensions
220x150x6 mm

AHA-BUCH GmbH

Einbeck, Germany

5-star seller

AbeBooks seller since August 14, 2006

Shipping rates from Germany to U.S.A.

Item30 to 40 business days7 to 14 business days
First itemUS$ 70.71US$ 82.34
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