21st Century Quality Management and Good Management Practices: Value Added Compliance for the Pharmaceutical and Biotechnology Industry

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21st Century Quality Management and Good Management Practices: Value Added Compliance for the Pharmaceutical and Biotechnology Industry

Format:  Hardcover,

250 pages

Publisher: Elsevier Science Ltd

Publish Date: Oct 2012

ISBN-13: 9781907568503

ISBN-10: 1907568506

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The life sciences industry is changing rapidly and the historical rules, regulations, government oversight are under pressure to modernize. The recent introduction of Pharmaceutical Quality Systems (PQS), Pharmaceutical Risk Management (QRM), Quality by Design (QbD), Process Analytical Technology (PAT) and risk-based validation have all challenged the traditional view that simple compliance with the basic Good Management Practices (GMP) rules is enough to satisfy stakeholders, regulators and patients. This book draws together these leading edge concepts and technologies and explains how they interlink with the traditional GMP rules and quality assurance. The book is a practical guide on how to apply these 21st century principles in the pharmaceutical and biotechnology workplace and include simple understandable examples and case studies on modern compliance. The book serves as a practitioners guide and is an ideal companion for pharmaceutical and biotechnology industry professionals and students studying quality management and GMP compliance.

Specifications

Publisher: Elsevier Science Ltd
Publish Date: Oct 2012
ISBN-13: 9781907568503
ISBN-10: 1907568506
Format: Hardcover
Number of Pages: 250
Shipping Weight (in pounds): 1.0
Product in Inches (L x W x H): 2.0 x 10.0 x 8.0
Walmart No.: 9781907568503

Book description

The life sciences industry is changing rapidly and the historical rules, regulations, government oversight are under pressure to modernize. The recent introduction of Pharmaceutical Quality Systems (PQS), Pharmaceutical Risk Management (QRM), Quality by Design (QbD), Process Analytical Technology (PAT) and risk-based validation have all challenged the traditional view that simple compliance with the basic Good Management Practices (GMP) rules is enough to satisfy stakeholders, regulators and patients. This book draws together these leading edge concepts and technologies and explains how they interlink with the traditional GMP rules and quality assurance.

The book is a practical guide on how to apply these 21st century principles in the pharmaceutical and biotechnology workplace and include simple understandable examples and case studies on modern compliance. The book serves as a practitioners guide and is an ideal companion for pharmaceutical and biotechnology industry professionals and students studying quality management and GMP compliance.

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