Validation Standard Operating Procedures A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries
Innbundet /
2006
/ Engelsk
Produktdetaljer
ISBN
9780849395291
Publisert
2006-05-30
Utgave
2. utgave
Utgiver
Vendor
CRC Press Inc
Vekt
1610 gr
Høyde
234 mm
Bredde
156 mm
Aldersnivå
P, UP, 06, 05
Språk
Product language
Engelsk
Format
Product format
Innbundet
Antall sider
1144
Forfatter
Biographical note
Haider, Syed Imtiaz
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 evaluations, it features 64 new protocols on topics such as sterility assurance, media fill guidelines, and environmental control.
Les mer
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.
Les mer
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.
Les mer
Produktdetaljer
ISBN
9780849395291
Publisert
2006-05-30
Utgave
2. utgave
Utgiver
Vendor
CRC Press Inc
Vekt
1610 gr
Høyde
234 mm
Bredde
156 mm
Aldersnivå
P, UP, 06, 05
Språk
Product language
Engelsk
Format
Product format
Innbundet
Antall sider
1144
Forfatter