How to Practice GMPs 7th ed. by P.P. Sharma

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How to Practice GMPs, 7th ed.
Indian GMP , WHO GMP, US FDA cGMP, Supplementary GMPs, PAT HACCP, ICH Q10 CAPA, QRM QbD   ICH  Q8
By P. P. Sharma

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

ICH has published ICH Q10 which is a document on Pharmaceutical Quality System. Participating countries of ICH are in the process of incorporating the systems mentioned in the document in their regulations. CAPA (Corrective Action and Preventive Action) system is an element of both ICH Q10 as well as ISO:9000. Overview of ICH Q10 and CAPA system has been included.

Amongst the appendices, the book has texts of Indian GMP, WHO GMP, US FDA GMP.X

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