About the Book:
"A Textbook of Pharmaceutical Quality Assurance" is a
comprehensive guide that delves into all aspects of quality assurance in the
pharmaceutical industry. Written specifically for industrial pharmacists, this
book covers the entire syllabus prescribed by the Pharmacy Council of India
(PCI) for the subject of pharmaceutical quality assurance in both the B.Pharm
and M.Pharm programs.
Designed to make the subject more interesting and easier to grasp, this
book presents a wealth of information in a condensed and cohesive format. It
includes the most up-to-date guidelines and regulations related to drug
development, manufacture, and supply, ensuring that readers gain the latest
knowledge in this rapidly evolving field.
This book places special emphasis on crucial topics such as quality
management, quality assurance and quality control, Total Quality Management
(TQM), Quality by Design (QbD), current Good Manufacturing Practices (cGMP),
Good Laboratory Practices (GLP), ISO standards, International Council for
Harmonisation (ICH) guidelines, stability testing, process validation,
calibration and validation of analytical equipment and methods, packaging
material control, warehousing, and materials management.
Ideal for students pursuing B.Pharm, M.Pharm, and Pharm.D. degrees,
"A Textbook of Pharmaceutical Quality Assurance" provides a
comprehensive understanding of the subject and equips future professionals with
the necessary knowledge and skills to ensure quality within the pharmaceutical
industry. |
| 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. |
