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How to Practice GMP
The concept of GMP originated in early sixties in the United States of America. In the late sixties, World Health Assembly (WHA) recognized the need for international guidelines for the manufacture of drugs (medicines) and requested a committee of experts to draft GMP guidelines which were made an integral part of WHO Certification Scheme of Pharmaceutical Products. In the seventies, a group of experts published good practices in the manufacture of medicines, popularly known as orange guide. In India, GMP were introduced under Schedule M to the Drugs & Cosmetics Rules in 1988.
The first edition of this book was published in 1991 which contained Indian GMP and WHO GMP. From the publication of first edition of this book, GMPs world over have been revised several times. Accordingly, the book has been reviewed time to time. Pursuing this philosophy, seventh edition of this book has been published recently.
ICH published three inter-related documents, namely, ICH Q8 (Pharmaceutical Development), ICH Q9 (Quality Risk Management), and ICH Q10 (Pharmaceutical Quality System) and recommended to three participating regions (US, EU and Japan) to incorporate these in the regulatory framework. The current edition of the book has information on all the contemporary GMPs and the concepts mentioned above. The book also has overview on important topics like validation, stability studies, AHU. In nutshell, the book is a treasure of information on GMP.
P P Sharma
Makeup Books
Shri. P.P. Sharma is B.Pharm (BITS, Pilani) and M.Pharm (Punjab University). He has been Rank Holder both at Graduate Level and Post Graduate Level and was awarded Gold Medal by Punjab University. After a short stint with Pharmaceutical Industry, he joined Drugs Control Dept. of Delhi Govt. where he worked in various capacities and retired as Dy. Drugs Controller and Licensing Authority. During his Professional career he had opportunities for training by Govt. of India and International Bodies like WHO and DANIDA. His approach to enforcement of law was ‘enforcement by education’ and this led him to write books. He has 06 books to his credit. He is faculty to various training programmes of Govt. of India and guest faculty to several pharmacy educational institutions. He is recipient of several National Awards notably, “Best Drugs Control Officer Awardâ€, “K C Chatterjee Memorial Awardâ€, “IPGA Lifetime Achievement Awardâ€. Know him more by reading his books……….