To successfully bring an Active Pharmaceutical Ingredient (API) to market, many steps must be followed to ensure compliance with governmental regulations. Active Pharmaceutical Ingredients is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of APIs globally.
Topics include:
Safety, efficacy, and environmental/regulatory requirements
Analysis of the recent movement of API manufacturing from the U.S. and Europe to countries such as India and China
The FDA's intensified foreign inspection program
Multi-use and flexible design facilities
The shift from maintenance scheduling to built-in reliability
This second edition focuses on the quality control regulations for APIs that have been added or amended since the first edition. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the United States and international regulatory agencies.
