Good Pharmaceutical Manufacturing Practice
Subtitle: Rationale and Compliance
Publisher: Informa Healthcare
Published: July 27, 2004
Language: eng
Format: Hardcover
Number of pages: 288
ISBN-13: 9780849319945
Subjects: Pharmaceutical technology; United States; Pharmaceutical industry; General; Science; Standards; Medical; Pharmacy; Health Care Delivery; Medical / Pharmacology; European Union Countries; Drug Guides; Drugs; Quality control
First sentence: The main objective of this book is to consider and compare the principle requirements of Good Manufacturing Practice (GMP), most notably in: The US Current Good Manufacturing Practice for Finished Pharmaceuticals regulations (the "US cGMPs") The Guide to Good Manufacturing Practice for Medicinal Products of the European Union (the "EC GMP Guide") This book will also discuss the rationale behind these requirements and will propose ways and means of complying with them.