Basic Sciences, Administration & Management, Health Law, Quality Control, Health Care Industries
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Overview
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.The book contains no figures.
Editorials
Booknews
A volume geared toward use as a resource for private and independent inspection companies, local and state inspection agencies, quality assurance organizations, and pharmaceutical manufacturers. Provides an examination of US laws affecting domestic and multinational production, and recommends practical ways to interpret and comply with regulations while meeting the goals of a comprehensive control system for product integrity. Annotation c. Book News, Inc., Portland, OR (booknews.com)Book Details
Published
June 10, 1991
Publisher
New York : M. Dekker, c1992.
Pages
256
Format
Hardcover
ISBN
9780824785949