About Book
This textbook offers a thorough exploration of Quality Assurance (QA) in the pharmaceutical industry, tailored to meet the requirements of the Pharmacy Council of India (PCI) syllabus. It comprehensively covers critical aspects of pharmaceutical quality systems, including Good Manufacturing Practices (GMP), Total Quality Management (TQM), ICH Guidelines, and ISO standards. The book highlights key principles of drug quality control, calibration, validation, and complaint management, emphasizing the application of scientific principles to guarantee product safety and efficacy. With clear explanations and practical examples, it is designed to equip both students and professionals with the essential knowledge and skills needed to maintain the highest standards of quality in pharmaceutical production and testing.
About Author
Dr. Mohan Gandhi Bonthu is a Professor at the School of Pharmaceutical Sciences, Sandip University, Nashik, Maharashtra. He holds a Ph.D. in Pharmaceutical Sciences from JNTU, Hyderabad, and an M.Pharm in Pharmaceutical Analysis and QA. With over 15 years of experience, his expertise includes analytical and bio-analytical method development, forced degradation studies, impurity profiling, and AQbD. Dr. Mohan has published over 42 scientific papers, holds multiple patents, and currently supervises 8 Ph.D. scholars.
Dr. G. Raveendra Babu is a Professor in the Department of Pharmaceutical Analysis at QIS College of Pharmacy, Ongole, Andhra Pradesh. He holds a Ph.D. from JNTU, Hyderabad. With expertise in drug bio-analytics, pharmacokinetics, and pharmaceutical stability analysis, Dr. Babu has published 74 research papers, 10 patents, 5 books, and 4 book chapters.
Mr. L. Ramachandra Reddy is the Associate Professor and Head of the Department of Pharmacognosy and Pharmaceutical Biotechnology at QIS College of Pharmacy, Ongole, Andhra Pradesh. He has published 50 research papers, 2 patents, and 2 books. His research interests focus on Pharmacognosy and Natural Products Chemistry.
Dr. M. Kishore Babu is the Professor and Principal at QIS College of Pharmacy, Ongole, Andhra Pradesh. He holds a Ph.D. in Pharmaceutical Sciences from JNTU, Hyderabad. With 76 M.Pharm dissertations supervised, 15 patents, and over 75 publications, his research interests include Novel Drug Delivery Systems and Nanotechnology.
Dr. N. Sai Krishna is the Professor and Principal at A.K.R.G. College of Pharmacy, Nallajerla, Andhra Pradesh, with a Ph.D. from GITAM University. He has published over 55 research papers, 4 patents, and 2 books. His research focuses on pharmacology and toxicology, particularly the effects of drugs and chemicals on living organisms.
