Validation and Qualification in Analytical Laboratories - Couverture rigide

Huber, Ludwig

 
9780849382673: Validation and Qualification in Analytical Laboratories

Synopsis

This Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards. With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory. This title serves as a complete source to the subject, and explains how to develop and implement a validation strategy for routine, non-routine, and standard analytical methods, covering the entire equipment, hardware, and software qualification process. It also provides guidance on qualification of certified standards, in-house reference materials, and people qualification, as well as internal and third party laboratory audits and inspections.

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À propos de l?auteur

Ludwig Huber

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

Autres éditions populaires du même titre

9781032644943: [(Validation and Qualification in Analytical Laboratories)] [By (author) Ludwig Huber] published on (July, 2007)

Edition présentée

ISBN 10 :  103264494X ISBN 13 :  9781032644943
Editeur : Taylor & Francis Inc, 2007
Couverture rigide