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How to Practice GMPs: A Treatise on GMPs (6th Edition) / Sharma, P.P.
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How to Practice GMPs: A Treatise on GMPs (6th Edition)
Sharma, P.P.
 
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List Price : US$ 124.94
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  Book ID : 42442
  ISBN-10 : 81-905957-4-1 / 8190595741
  ISBN-13 : 978-81-905957-4-2 / 9788190595742
  Place of Publication : Delhi
  Year of Publication : 2010
  Edition : (Sixth Edition)
  Language : English
  xii, 825p., App., Index, 24 cm. (First Edition pub. in 1991) (Second Edition pub. in 1995) (Third Edition pub. in 2001) (Fourth Edition pub. in 2004) (Fifth Edition pub. in 2006) (Fifth Edition Reprinted in 2008)
   
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 CONTENTS
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 DESCRIPTION
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The current edition is the sixth edition. While updating the book, author has taken in to consideration various supplementary GMP guidelines published by WHO and EU Guidance on GMP. In this edition, three new chapters have been added and include:

Supplementary GMPs for Herbal Medicines, GMP Considerations for Investigational Pharmaceutical Products for Clinical Trials, GMPs for Homoeopathic Medicines.

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 in chapter 10 of the book.

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

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