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Indian pharmaceutical industry is becoming global at high pace. This resulted in high pressure on the industry for quality products and practices. Thus cGMP has acclaimed Key position. Practicing cGMP requires clear understanding at conceptual and implementation level and that too at shop floor and middle management level. This book is written in simple and easy to implement manner. Salient features All current issues of cGMP demanded by regulatory authorities like W.H.O. M.H.R.A., T.G.A., U.S.F.D.A, and also Indian F.D.A. are fully discussed, profusely referenced and thoroughly illustrated in…mehr

Produktbeschreibung
Indian pharmaceutical industry is becoming global at high pace. This resulted in high pressure on the industry for quality products and practices. Thus cGMP has acclaimed Key position. Practicing cGMP requires clear understanding at conceptual and implementation level and that too at shop floor and middle management level. This book is written in simple and easy to implement manner. Salient features All current issues of cGMP demanded by regulatory authorities like W.H.O. M.H.R.A., T.G.A., U.S.F.D.A, and also Indian F.D.A. are fully discussed, profusely referenced and thoroughly illustrated in simple and easy to understand language. Covers other important topics like, plant, site security, environmental issues, distribution of products, and preparing for the regulatory audits etc.
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Autorenporträt
Dr. Manohar A. Potdar, M.Pharm (BITS Pilani), Ph.D. (Production Management) USA, Currently President Technical, Doshi Consultants Pvt. Ltd., Pharmaceutical Plant Design and Validation Consultants, was a professor emeritus of Pharmaceutical Sciences at Poona College of Pharmacy, Bharati Vidyapeeth University, Pune, India. He thought Under Graduate and Post Graduate courses in Pharmaceutical Administration, Pharmaceutical Technology, Plant Design and Operations and Quality Assurance Techniques. He guided many research students in the above subjects.