A Textbook of Pharmaceutical Quality Assurance

This book describes all aspects of pharmaceutical quality assurance needed for an industrial pharmacist. 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 About the Author: K. P. R. Chowdary is one of the Senior most Professors of Pharmacy in the country, having 43 years of experience in teaching, research and administration in Pharmacy. He served as Professor, HOD and Principal of Andhra University College of Pharmaceutical Sciences, Visakhapatnam during 1977 to 2010. Presently he is serving as Research Director, Vikas Institute of Pharmaceutical Sciences, Rajahmundry since 2011; Chairman, BOS in Pharmacy, Jawaharlal Nehru Technological University Kakinada, Kakinada and Advisor KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada. He actively involved in research in Pharmacy and has guided the research work of 96 Ph.D. scholars, 165 M.Pharm graduates and published 480 research papers in National and International journals of repute and obtained 05 patents. He has received 16 National and state level awards for his outstanding contribution to Pharmacy Education and Research. The notable among them are Life Time Achievement Award in Pharmacy – 2017 National Award from ABAP; Prof. C. J. Shishoo Award for Research in Pharmaceutical Sciences - 2014 from APTI; Best Principal Award - 2008 National Award from APTI; Best Teacher Award - 2007 from Government of Andhra Pradesh; Best Pharmacy Teacher of the Year 2003 National Award from APTI; Andhra Pradesh Scientist Award - 2002 from Government of Andhra Pradesh; Research Award-2000 from Indian Drug Manufacturers Association (IDMA), Mumbai.