Description
Bsp Books Textbook of Pharmaceutical Quality Assurance (Pb) by Chowdary K P R
This book describes all aspects of pharmaceutical quality assurance needed for an industrial pharmacist and the book covers the entire syllabus prescribed by PCI for the subject of pharmaceutical quality assurance in B Pharm and M Pharm programs under new uniform regulations. This book has been designed to make the subject more interesting, more comprehensive and easy to grasp. Huge information on the subject is presented in condensed and cohesive form. Current updated guidelines and regulations related to drug development, manufacture and supply are included. As such the book provides latest knowledge on the subject. Special emphasis is given on topics like quality management, quality assurance and quality control, TQM, QbD, cGMP, GLP, ISO, ICH guidelines, stability testing, process validation, calibration and validation of analytical equipments and methods, packaging material control, ware housing and materials management. This book is ideal for B.Pharm, M.Pharm and Pharm.D. students. Contents: 1. Quality Assurance, Quality Management and GMP 2. Total Quality Management 3. ICH Guidelines 4. Ich Stability Testing Guidelines and Proceudures 5. Quality by Design (QbD) 6. ISO 9000 and ISO 14000 7. Validation in cGMP 8. Good Manufacturing Practices (GMP) - Part 1 (Introduction, Summary, Organization, Personnel and Premises) 9. Good Manufacturing Practices (GMP) - Part II (Equipment and Raw Materials) 10. Good Manufacturing Practices (GMP) - Part III (Documentation and Records) 11. Good Manufacturing Practices (GMP) - Part IV 12. Pharmaceutical Packaging and Quality Control Tests of Packaging Materials 13. Good Laboratory Practices (GLP) 14. Calibration and Validation of Analytical Instruments 15. Warehousing and Materials Management