Validation and Qualification in Analytical Laboratories

Ludwig Huber

ISBN 10: 084938267X / ISBN 13: 9780849382673

Editore: CRC Press, 2007

nach der Bestellung gedruckt Neuware - Printed after ordering - 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. Codice articolo 9780849382673

Riassunto:

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.

Informazioni sull'autore: Ludwig Huber

Dati bibliografici

Titolo: Validation and Qualification in Analytical ...
Casa editrice: CRC Press
Data di pubblicazione: 2007
Legatura: Buch
Condizione: Neu
Edizione: seconda edizione