Quality Assurance and Quality Management in Pharmaceutical Industry

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Quality Assurance (QA) is a measure of the degree of sophistication of managerial, scientific and technical tools used in the design and implementation of product process of any industry. QA is the most vital function of Total Quality Management (TQM) in pharmaceutical industry. This book presents the basic concepts on various topics like QMS, GLP, GMP, Quality Audit, Statistical Quality Control and analytical methods for QA. The elements, requirement and interpretation of ISO 9000 series of QMS are presented in detail. The principles of GLP and GMP are discussed which are expected to guide the manufacturer and the regulator for maintaining high scientific and professional standards for ensuring only drugs of highest quality are produced and marketed. Each chapter is provided with a summary and typical questions and in Appendix, the latest information on the International Standards of QMS, GLP and GMP are included for ready reference.

ABOUT THE AUTHOR Y. Anjaneyulu

Y. Anjaneyulu, M.Tech (Environmental Management), M.Sc. (Environmental Technology) and M.Sc. (Industrial Chemistry). He has 30 years of teaching experience and presently working as Director, Institute of Science and Technology, Jawaharlal Nehru Technological University, Hyd. He is involved in designing and conducting postgraduate courses. He has already authored books on environmental science and technology, besides presenting 70 research papers in journals.