Validation and Qualification in Analytical Laboratories

Ludwig Huber (Autor)

Buch | Hardcover

336 Seiten

1998
Crc Press Inc (Verlag)
978-1-57491-080-3 (ISBN)

Infos

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.

Inhalt

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.

Produkt-Details

• Erscheint lt. Verlag: 31.10.1998
• Verlagsort: Bosa Roca
• Sprache: englisch
• Maße: 178 x 254 mm
• Gewicht: 771 g
• Themenwelt: Medizin / Pharmazie ► Allgemeines / Lexika
• Themenwelt: Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
• Themenwelt: Medizin / Pharmazie ► Pflege
• Themenwelt: Naturwissenschaften ► Chemie ► Analytische Chemie
• Themenwelt: Technik
• ISBN-10: 1-57491-080-9 / 1574910809
• ISBN-13: 978-1-57491-080-3 / 9781574910803
• Zustand: Neuware