A comprehensive when-and-how-to-do-it guide, this book and CD-ROM combination provides administrative solutions for achieving compliance with key FDA guidelines on good manufacturing practice (GMP), good laboratory practice (GLP), and validation. The text shows readers how to establish test function
Validation Standard Operating Procedures: A Step-by-Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries
โ Scribed by Haider S. I.
- Year
- 2002
- Tongue
- English
- Leaves
- 1118
- Category
- Library
No coin nor oath required. For personal study only.
โฆ Synopsis
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.
๐ SIMILAR VOLUMES
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. Wi
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. Wi
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