Methodologies for transfer of an analytical method : Quality Assurance

Language: English

Published by LAP LAMBERT Academic Publishing, 2012

3846514713 / 9783846514719

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nach der Bestellung gedruckt Neuware - Printed after ordering - An analytical method transfer is a complete process that consists in transferring a validated analytical method from a sending laboratory (called sender) to a receiving laboratory (called receiver) after having experimentally demonstrated that it also masters the method. The process for the transfer of analytical methodology is, on the surface, a relatively simple operation. In its most common form, analytical method transfer is the verification that a method or test procedure works in an equivalent fashion at two or more different sites or laboratories and meets all acceptance criteria. This process is driven by compliance and governed by a statistical treatment of the resulting data. McGonigle defined Method transfer as the introduction of a validated method into a designated laboratory so that it can be used in the same capacity for which it was originally developed . The transfer of a method from a laboratory to a production site is an important step in the development cycle of new pharmaceutical products.…

Seller Inventory # 9783846514719

Title
Methodologies for transfer of an analytical method : Quality Assurance
Author
Vidhi M. Desai
Publisher
LAP LAMBERT Academic Publishing
Publication year
2012
Condition
Neu
Binding
Taschenbuch
Language
English
ISBN 10
3846514713
ISBN 13
9783846514719
Item weight
143 grams
Dimensions
220x150x6 mm

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