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.

Addresses the practical application of quality management and GMPs

Draws together five 21st century industry initiatives that will shape the future of industry compliance

Moves readers from thinking about 'rule-based' compliance to 'value added' compliance