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

Validation of Active Pharmaceutical Ingredients, revised 2nd edition includes new chapters addressing postapproval changes, technology transfer, international cGMP guidelines/FDA guidance progress, and facility inspection issues.

Contents

1. Introduction
2. The Legal Framework for the Regulation of Active Pharmaceutical Ingredients
3. The Legal Basis for Validation
4. Drug Master Files
5. FDA's Perspectives on API Manufacturing, cGMP Controls & Validation
6. Domestic and Foreign API Manufacturing Facility Audits & Findings
7. Validation of APIs: A Case Study
8. API Validation
9. Active Pharmaceutical Ingredient Valication: An Overview and Comparative Analysis
10. Impurities in Drug Substances and Drug Products
11. Investigating Process Deviations
12. Technology Transfer: Active Pharmaceutical Ingrediants
13. Postapproval Changes to Bulk Drug Substances
14. Vendor Qualification and Certification
15. Quality Assurance Systems
16. Cleaning for Active Pharmaceutical Manufacturing Facilities
17. Validation of Sterile APIs
18. Validation of Biotechnology Active Pharmaceutical Ingredients
19. Microbiological Attributes of Active Pharmaceutical Ingredients
20. Excipients: Facility, Equipment, and Processing Changes
21. API Terminology & Documentation

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