Good Pharmaceutical Manufacturing Practice

Rationale and Compliance
1. Auflage 2004
ISBN: 978-0-8493-1994-5
Verlag: CRC Press

Buch, Englisch, 520 Seiten, Format (B × H): 183 mm x 260 mm, Gewicht: 1162 g

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.

Zielgruppe

Academic and Professional Practice & Development

Autoren/Hrsg.

Sharp, John

Fachgebiete

• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie
• Wirtschaftswissenschaften Betriebswirtschaft Management Compliance
• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie

Inhaltsverzeichnis

Introduction - Status and Applicability of U.S. Regulations/E.U. Guidelines - General Quality Issues. Personnel, Organization and Training. Premises/Buildings and Facilities. Contamination and Contamination Control. Equipment. Materials Control. Production and Process Controls. Packaging and Labeling Control. Holding and Distribution. Laboratory Controls. Records and Reports. Returned and Salvaged products. Sterile Products Manufacture. Other GMP Issues.

Über Autor(innen)

Sharp, John