-
Anglický jazyk
Huber, L: Validation and Qualification in Analytical Laborat
Autor: Ludwig Huber
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,... Viac o knihe
Na objednávku, dodanie 2-4 týždne
238.68 €
bežná cena: 265.20 €
O knihe
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.
- Vydavateľstvo: CRC Press
- Rok vydania: 2007
- Formát: Hardback
- Rozmer: 235 x 157 mm
- Jazyk: Anglický jazyk
- ISBN: 9780849382673
