Fr. 405.00

Validation Standard Operating Procedures - A Step By Step Guide for Achieving Compliance in Pharmaceutical,

English · Hardback

Shipping usually within 1 to 3 weeks (not available at short notice)

Description

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Informationen zum Autor Haider! Syed Imtiaz Klappentext Spanning every critical element of validation for any pharmaceutical! diagnostic! medical device or equipment! and biotech product! this edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. Zusammenfassung 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. Inhaltsverzeichnis 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.

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