520 pages | 39 B/W Illus.
With over twenty different official regulatory statements worldwide on Good Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the most influential and most frequently referenced.
Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans the most important substance from the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP guide, 2002). The author uses his 40+ years of experience in technical management, production, quality assurance, and distribution within the pharmaceutical industry, offering a hands-on guide to better understand and implement optimal pharmaceutical practices.
This book also compares the principle requirements of GMP, and explores the reasoning behind these requirements and ways to comply with them. Relevant topics include personnel, documentation, premises and equipment, production, quality control, self-inspection, recalls, and more. This is an essential guidebook for those who wish to expand their pharmaceutical business in any international capacity.
"…provides a pleasantly different approach to the destination of GMP compliance….represents a superb no-nonsense approach to the subject matter and will maintain its value well into the future."
-European Journal of Parenteral and Pharmaceutical Sciences
"…gives an immediate and good overview of the differences and similarities between the US and EU interpretation of…how to deal with Good Manufacturing Practices."
Introduction - StatU.S. and Applicability of U.S. Regulations/E.U. Guidelines - General Quality Issues
Personnel, Organization and Training
Premises/Buildings and Facilities
Contamination and Contamination Control
Production and Process Controls
Packaging and Labelling Control
Holding and Distribution
Records and Reports
Returned and Salvaged Products
Other GMP Issues