ABSTRACT

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.

Introduction. The Legal Framework for the Regulation of APIs. The Legal Basis for Validation. Drug Master Files. FDA's Perspectives on API Manufacturing, cGMP Controls & Validation. Domestic & Foreign API Manufacturing Facility Audits & Findings. Validation of APIs: Case Study. API Validation. Impurities in Drug Substances & Products. Investigating Process Deviations. Technology Transfer. Postapproval Changes. Vendor Qualification & Certification. QA Systems. Cleaning for API Manufacturing Facilities. Validation of Sterile APIs. Validation of Biotechnology APIs. Microbiological Attributes of APIs. Excipients.