Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control

by Sidney H. Willig, James R. Stoker

Revised and updated throughout to ensure GMP compliance in a rapidly changing regulatory environment, this timely reference examines U.S. laws affecting domestic and multinational pharmaceutical manufacturing - recommending practical ways to interpret and comply with FDA CGMP regulations while meeting the goals of a comprehensive control system to preserve product integrity. Written by two seasoned corporate officials and enriched by their hands-on experience in the field, Good Manufacturing Practices for Pharmaceuticals, Fourth Edition contains new chapters on relating the impact of GMPs to the production of bulk pharmaceutical products...preapproval inspection in the drug approval process...European, Canadian, and World Health Organization's GMPs...comparing the GMP regulatory process with other quality approaches such as the ISO 9000 and the Malcolm Baldrige programs...and the import/export of pharmaceuticals and related products subject to CGMPs.

256 pages, Hardcover

First published October 1, 1991

Reviews

[Vamsi · Rating 4 out of 5]

nice book

[Navidhabansal · Rating 3 out of 5]

I Wanna to read it