Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluati
Auflage
Sprache
Verlagsort
Verlagsgruppe
Zielgruppe
Für Beruf und Forschung
Pharmaceutical, medical, biotech, and design engineers; manufacturing personnel; research and development scientists; and quality control professionals.
Editions-Typ
Illustrationen
16 s/w Abbildungen, 276 s/w Tabellen, 5 s/w Photographien bzw. Rasterbilder
16 b/w images, 276 tables and 5 halftones
Dateigröße
ISBN-13
978-1-4200-0941-5 (9781420009415)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Klassifikation
Introduction to Validation. Fundamentals of Validation SOPs. Validation Glossary. Calibration of Instruments. Training on the Job. Guidelines for Area Classification and Air Handling. Validation of a Steam Sterilizer. Kneading Machine. Blistering Machine. Installation Qualification of Computerized Equipment. Validation of Microbiological Methods. Vendor Certification. Facility Qualification. Recommended Reading.
