Validation and Qualification in Analytical Laboratories
Huber, Ludwig
ISBN 10: 1574910809 ISBN 13: 9781574910803
Editore: CRC Press, 1998
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Riassunto:
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.
Contenuti: Chapters include: Regulations, Standards & Guidelines. Terminology & Validation Strategy. Design Qualification. Installation Qualification. Operational Qualification. Performance Qualification & Maintenance. Operational Qualification of Software & Computer Systems. Validation of Analytical Methods. Data Validation & Evaluation of Uncertainty. Reference Standards. People. Proficiency Testing for External Laboratory Qualification. Audits.
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Dati bibliografici
Titolo: Validation and Qualification in Analytical ...
Casa editrice: CRC Press
Data di pubblicazione: 1998
Legatura: hardcover
Condizione: Good
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Validation and Qualification in Analytical Laboratories
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Condizione: good. A copy that has been read, remains in good condition. All pages are intact, and the cover is intact. The spine and cover show signs of wear. Pages can include notes and highlighting and show signs of wear, and the copy can include "From the library of" labels or previous owner inscriptions. 100% GUARANTEE! Shipped with delivery confirmation, if you're not satisfied with purchase please return item for full refund. Ships via media mail. Codice articolo OTV.1574910809.G
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Validation and Qualification in Analytical Laboratories
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Hardcover. Condizione: Good. No Jacket. Pages can have notes/highlighting. Spine may show signs of wear. ~ ThriftBooks: Read More, Spend Less. Codice articolo G1574910809I3N00
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