Active Pharmaceutical Ingredients, Second edition is a comprehensive guide to the development, manufacturing, and regulation of the preparation and use of Active Pharmaceutical Ingredients (APIs) globally.

This new edition brings you up-to-date with the quality control regulations for APIs that have been added or amended since the first edition was published in 2005. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the US and international regulatory industries.

New features include:

• chapters on safety, efficacy, and environmental/regulatory requirements
• analysis of the recent movement of API manufacturing from the US and Europe to countries such as India and China
• discussions on both US and international regulatory requirements
• information about the FDA’s intensified foreign inspection program
• data on multi-use and flexible design facilities
• the shift from maintenance scheduling to built-in reliability

Contents

1. Introduction
2. Bulk Drugs: The Process Development Task
3. Bulk Drugs: Process Design, Technology Transfer, and First Manufacture
4. Design and Construction of API Manufacturing Facilities
5. Regulatory Affairs: Requirements and Expectations
6. Regulatory Affairs: Guidelines, Evolving Strategies, and Issues
7. Validation of Active Pharmaceutical Ingredients
8. Quality of Active Pharmaceutical Ingredients
9. Environmental Control
10. Thermochemical Process Safety—An Introduction
11. Design and Operating Practices for Safety
12. Plant Operations
13. Sterile Bulk Active Pharmaceutical Ingredient Production
14. Biological Production of Active PharmaceuticalIntermediates
15. Supply Management
16. Equipment Maintenance and Reliability

Index

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