Features
Covers process validation, cleaning validation, quality assurance, technology transfer, microbial controls, biotechnology, and more
Explains the relationship between GMP and validation and addresses how to validate correctly
Describes in detail the FDA review process for Drug Master Files and the importance of keeping it current
Discusses which systems are required to conform to GMP regulations
Addresses change control programs and the possibility of a lack of adequate investigations
Compares the validation process for APIs with the validation of drug products
Delineates the validation process for APIs and compares Prospective Validation with Retrospective Validation
Summary
Much has happened in the area of bulk pharmaceutical good manufacturing practice (GMP) and validation since the first publication of Validation of Active Pharmaceutical Ingredients. Revised, updated, and expanded, this second edition includes new chapters addressing postapproval changes, technology transfer, international cGMP guidelines/FDA guidance progress, and facility inspection issues. The basic philosophy and principles of GMP and validation have not changed, but new terminology had been introduced, and old terminology had been better defined, improving the understanding of related concepts and principles. The book gives you a working knowledge of the regulatory process that will facilitate your organization's compliance with regulations.

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