Books by Ramkumar Dubey

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.