Lyophilization Process

Language: English

Published by LAP LAMBERT Academic Publishing Okt 2019, 2019

3659789682 / 9783659789687

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Seller: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, GermanyBuchWeltWeit Ludwig Meier e.K.

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This item is printed on demand - it takes 3-4 days longer - Neuware -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. 96 pp. Englisch.

Seller Inventory # 9783659789687

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

BuchWeltWeit Ludwig Meier e.K.

Bergisch Gladbach, Germany

5-star seller

AbeBooks seller since January 11, 2012

Shipping rates from Germany to U.S.A.

Item5 to 15 business days5 to 15 business days
First itemUS$ 26.74US$ 26.74
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BuchWeltWeit Ludwig Meier e.K.

Germany