This "Second Edition" brings you up-to-date with 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 US and international regulatory industries.
REVISION OF A BESTSELLER - provides updates on the quality control regulations for APIs that have been added or amended since the first edition to ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the US and international regulatory industries
NEW CHAPTERS - on safety, efficacy, and environmental/regulatory requirements keeps readers up-to-date with the latest in the field
EXPERT ANALYSIS - of the recent movement of API manufacturing from the US and Europe to countries such as India and China keeps pharmaceutical professionals and drug manufacturers aware of current and potential changes in regulations
DETAILED DISCCUSIONS - of both US and international regulatory requirements and the FDA's intensified foreign inspection program enables readers to adequately prepare for and pass inspections