Validation and Qualification in Analytical Laboratories

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Validation and Qualification in...

Validation and Qualification in Analytical Laboratories

Name: Validation and Qualification in Analytical Laboratories
ISBN: 9780849382673

Huber Ludwig

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This Second Edition explains how 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 and in-house reference materials and people qualification, as well as internal and third party laboratory audits and inspections.

سب زمرہ:

Medicine

سال:

2007

اشاعت:

ناشر کتب:

Informa Healthcare

زبان:

english

صفحات:

314

ISBN 10: