Sharp Good Pharmaceutical Manufacturing Practice

Rationale and Compliance
1. Auflage 2004
ISBN: 978-0-203-48911-6
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 520 Seiten

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

Manufacturing and QA personnel, compliance personnel, Pharmaceutical consultants, and drug developers

Autoren/Hrsg.

Sharp, John

Fachgebiete

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

Inhaltsverzeichnis

Introduction - StatU.S. 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 Labelling Control
Holding and Distribution
Laboratory Controls
Records and Reports
Returned and Salvaged Products
Sterile Products
Other GMP Issues