Title: Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control (Drugs and the Pharmaceutical Science Series No 52)
Publisher: Marcel Dekker Inc
Publication Date: 1991
Language: English
ISBN 10: 0824785940
ISBN 13: 9780824785949
Binding: Hardcover
Edition: 3rd Edition
Condition: Good
Dust Jacket Condition: No Jacket
Weight: 1.35 pounds

About this title

Synopsis

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.

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