Active Pharmaceutical Ingredients: Development, Manufacturing, and Regulation, Second Edition Nusim Stanley
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…
Specifikacia Active Pharmaceutical Ingredients: Development, Manufacturing, and Regulation, Second Edition Nusim Stanley
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 requirementsAnalysis of the recent movement of API manufacturing from the U.S. and Europe to countries such as India and ChinaThe FDA's intensified foreign inspection programMulti-use and flexible design facilitiesThe shift from maintenance scheduling to built-in reliabilityThis second edition focuses on the quality control regulations for APIs that have been added or amended