Active Pharmaceutical Ingredients Development, Manufacturing and Regulations Second edition edited by Stanley H. Nusim

Active Pharmaceutical Ingredients
Development, Manufacturing and Regulations
Second edition
edited by Stanley 

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


Introduction
Bulk Drugs: The Process Development Task
Bulk Drugs: Process Design, Technology Transfer, and First Manufacture
Design and Construction of API Manufacturing Facilities
Regulatory Affairs: Requirements and Expectations
Regulatory Affairs: Guidelines, Evolving Strategies, and Issues
Validation of Active Pharmaceutical Ingredients
Quality of Active Pharmaceutical Ingredients
Environmental Control
Thermochemical Process Safety—An Introduction
Design and Operating Practices for Safety
Plant Operations
Sterile Bulk Active Pharmaceutical Ingredient Production
Biological Production of Active PharmaceuticalIntermediates
Supply Management
Equipment Maintenance and Reliability
Index