Good Pharmaceutical Manufacturing Practice: Rationale and Compliance

by John Sharp

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 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.

520 pages, Hardcover

First published July 27, 2004

About the author

Librarian Note: There are more than one author in the Goodreads database with this name.

John R. Sharp worked as a linguist and analyst for the U.S. Government for over 40 years, teaching and writing curricula for Modern Standard Arabic and several Arabic dialects. During his studies in Cairo, he became fascinated with Egyptology and the ancient Egyptian language, but was frustrated at not finding a good, searchable index of pharaohs' cartouches (name rings), so he decided to make one himself, a project that took several decades. He lives in Hawaii.