Articles liés à Validation and Qualification in Analytical Laboratories

Validation and Qualification in Analytical Laboratories - Couverture rigide

Huber, Ludwig

 
9781574910803: Validation and Qualification in Analytical Laboratories
Couverture rigide
ISBN 10 : 1574910809 ISBN 13 : 9781574910803
Editeur : CRC Press Inc, 1998

Synopsis

This book explains how to improve product quality while achieving compliance with the world's regulatory standards. A complete guide and reference, it teaches you how to develop and implement a validation strategy for routine, nonroutine, and standard analytical methods encompassing the entire equipment, hardware, and software qualification process. It includes examples and templates to help speed you through the validation process. Chromatographs, spectrophotometers, titrators, methods, reference compounds, and every possible item and category have been addressed. In addition to guidelines on the qualification of standards, certified and in-house reference materials, and employee qualification, it covers internal and third-party lab audits and inspections. Case studies, checklists, flowcharts, templates, and key SOPs support the text. All major regulations and quality standards are covered: US GLP, GMP, GCP, EN45001, ISO 9000 Series, NAMAS, ISO Guide 25, & corresponding interpretation & inspection guides.

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

Présentation de l'éditeur

This book explains how to improve product quality while achieving compliance with the world's regulatory standards. A complete guide and reference, it teaches you how to develop and implement a validation strategy for routine, nonroutine, and standard analytical methods encompassing the entire equipment, hardware, and software qualification process. It includes examples and templates to help speed you through the validation process. Chromatographs, spectrophotometers, titrators, methods, reference compounds, and every possible item and category have been addressed. In addition to guidelines on the qualification of standards, certified and in-house reference materials, and employee qualification, it covers internal and third-party lab audits and inspections. Case studies, checklists, flowcharts, templates, and key SOPs support the text. All major regulations and quality standards are covered: US GLP, GMP, GCP, EN45001, ISO 9000 Series, NAMAS, ISO Guide 25, & corresponding interpretation & inspection guides.

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

Éditeur
CRC Press Inc
Date d'édition
1998
Langue
anglais
ISBN 10 
1574910809
ISBN 13 
9781574910803
Reliure
Relié
Nombre de pages
318
Coordonnées du fabricant
non disponible
Personne responsable
non disponible