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. Title Of Book - p. iii 2. Cover - p. iii 3. Title page - p. iii 4. Copyright - p. iv 5. Contents - p. iv 6. Acknowledgments - p. xix 7. Abbreviations - p. xxi 8. Chapter 1 Product life cycle - p. 1 9. Chapter 2 Good manufacturing practice - p. 43 10. Chapter 3 Elements of quality management - p. 65 11. Chapter 4 Quality systems and international standards - p. 91 12. Chapter 5 The management of quality - p. 103 13. Chapter 6 Inspections and auditing - p. 119 14. Chapter 7 Quality improvement programs - p. 149 15. Chapter 8 Corrective and preventive action - p. 187 16. Chapter 9 Calibration - p. 219 17. Chapter 10 Validation - p. 233 18. Chapter 11 Technology transfer - p. 243 19. Chapter 12 Water for pharmaceutical use - p. 263 20. Chapter 13 Pharmaceutical microbiology - p. 299 21. Chapter 14 Good distribution practice - p. 327 22. Index - p. 345
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. Title Of Book - p. iii 2. Cover - p. iii 3. Title page - p. iii 4. Copyright - p. iv 5. Contents - p. iv 6. Acknowledgments - p. xix 7. Abbreviations - p. xxi 8. Chapter 1 Product life cycle - p. 1 9. Chapter 2 Good manufacturing practice - p. 43 10. Chapter 3 Elements of quality management - p. 65 11. Chapter 4 Quality systems and international standards - p. 91 12. Chapter 5 The management of quality - p. 103 13. Chapter 6 Inspections and auditing - p. 119 14. Chapter 7 Quality improvement programs - p. 149 15. Chapter 8 Corrective and preventive action - p. 187 16. Chapter 9 Calibration - p. 219 17. Chapter 10 Validation - p. 233 18. Chapter 11 Technology transfer - p. 243 19. Chapter 12 Water for pharmaceutical use - p. 263 20. Chapter 13 Pharmaceutical microbiology - p. 299 21. Chapter 14 Good distribution practice - p. 327 22. Index - p. 345
