Quality, Second Edition provides comprehensive applications of regulatory guidelines and quality concepts and methodologies related to pharmaceutical manufacturing. The book presents background theory and applied descriptions of guidelines and concepts, along with questions and problems. Users will find real-life examples from industry and guidelines for the practical application of tools that can be referenced by operators, engineers and management. New content on QbD, Lean, Six Sigma, basic data analysis, and CAPA tools is also included in this updated edition, making it an excellent resource for practitioners, those pursuing pharmaceutical related certifications, and for students trying to learn more about pharmaceutical manufacturing. Fully revised, updated and 25% expanded new edition Features new topics on QbD, Lean, Six Sigma, Basic data analysis, CAPA tools and Pharma 4.0 Includes end-of-chapter summaries, questions and/or problems Presents real-life case studies from industry Provides detailed steps and examples for applying guidelines and quality tools INDICE: 1. Product Life Cycle 2. Elements of Quality Management 3. Quality Systems 4. The Management of Quality 5. Good Manufacturing Practice 6. Validation 7. Good Distribution Practice 8. Technology Transfer 9. Inspection and Auditing 10. Calibration 11. Pharmaceutical Microbiology 12. Water for Pharmaceutical Use 13. Quality Improvement Programmes 14. Corrective and Preventative Action Using Quality Tools and Techniques
- ISBN: 978-0-323-90815-3
- Editorial: Butterworth-Heinemann
- Encuadernacion: Rústica
- Páginas: 362
- Fecha Publicación: 01/06/2022
- Nº Volúmenes: 1
- Idioma: Inglés