Quality Assurance and Quality Management - Anjaneyulu, Y.; Marayya, R.
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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…mehr

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Produktbeschreibung
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. "As very few books are available on this important subject, this book will be very useful as text book for students of both graduate and post-graduate classes in Pharmacy, Analytical Chemistry and allied subjects. It shall serve as ready reference for scientific and management personnel working in various pharmaceutical industries for understanding the basic concep
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Autorenporträt
Dr. Anjaneyulu Yerramilli, Ph.D ,FRSC (London) is presently working as Professor & Director Center for Advanced Energy Studies at K. L. University, A.P, India. Earlier (2006-2014) he worked as Professor in Chemistry/Environment and Director Trent Lott Geospatial &Visualization Research Center at Jackson State University (JSU) Jackson, MS,USA, and Professor & Head Center for Environment(1990-2002) and Director Institute of Science and Technologies (IST) (2002-2005) at JNTU Hyderabad, India. During his stay at JSU, USA he worked as PI for programs: Department of Defense-sponsored program on High Performance Computation for Development of Novel nano Materials, Atmospheric Dispersion Modeling of Gulf Coast, sponsored by NOAA, and for a NSF-sponsored program on Collaborative Research CI-TEAM Demonstration Project entitled Water HUB for Cyber Enabled Training, Education, and Research in Water Resources. He has also published a number of papers on application gold nano particles, Molecular Imprinted Polymers (MIP), simulation of mesoscale coastal circulation of Gulf Coast for air pollution dispersion by integrating WRF, HYSPLIT, SMOKE and CMAQ models. (http://chem.jsums.edu/anjaneyulu). 38 students received Ph.D degrees under his supervision and he published more than 150 research papers in peer reviewed journals which have more than 1000 citations and presented at various international conferences. He has authored a number of books on Energy Resources, Utilization and Technologies (2012-BS Publications/CRC Press) Environmental Impact Assessment Methodologies (2011, BS Publications/CRC Press), Introduction to Environmental Science (2005, BS Publications), Hazardous Waste Management and Air Pollution and Control Technologies (2002, Allied Publishers).