Quality, second edition, provides comprehensive application of regulatory guidelines and quality concepts and methodologies related to pharmaceutical manufacturing. It is an excellent resource for practitioners, those pursuing pharmaceutical related certifications, and for students trying to learn more about pharmaceutical manufacturing. This book provides the background theory, applied descriptions of the guidelines and concepts, plus questions and problems at the end of the chapters that will help provide practice for the reader to apply the concepts. In this book the authors share their combined 60+ years of extensive practical experience in the industry and in process improvement combined with detailed understanding of the needs of the industry and education system. This book provides real-life examples from industry and guidelines for practical application of tools that can be referenced by operators, engineers, and management.This book is fully revised, updated, and expanded with new content in areas such as QbD, Lean, Six Sigma, basic data analysis, and CAPA tools.

1. Product Life Cycle 2. Good Manufacturing Practice 3. Elements of Quality Management 4. Quality Systems and International Standards 5. The Management of Quality 6. Inspections and Auditing 7. Quality Improvement Programmes 8. Corrective and preventive actions 9. Calibration 10. Validation 11. Technology Transfer 12. Water for Pharmaceutical Use 13. Pharmaceutical Microbiology 14. Good Distribution Practice