Description
The book, How to Practice GMPs authored by P.P.Sharma, senior regulatory officer of the Drugs Control Department of Government of Delhi was first published in 1991 after incorporation of GMPs under Schedule M to the Drugs and Cosmetics Rules, 1945. It was the first book in India on GMP. The book has been reviewed regularly by the author and subsequent editions appeared in the years mentioned below:
Second edition 1995
Third edition 2001
Fourth edition 2004
Fifth edition 2006
Sixth edition 2010
Seventh edition 2015
The current edition is the seventh edition. While updating the book, author has taken in to consideration various supplementary GMP guidelines published by WHO and EU Guidance on GMP.
Highlights of 7th Ed. :
- Two New Chapters have been added
- Pharmaceutical Development has been covered
- Principles of QbD added
- ICH & WHO Guidelines on QRM included
- GMP guidelines on medicinal gases added
- Revised WHO GMP guidelines on API and sterile products included
- Entire text of the book reviewed and updated
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.
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