Regulatory Science of Medical Products
Online ISSN : 2189-0447
Print ISSN : 2185-7113
ISSN-L : 2185-7113
Outline of the WHO’s Good Pharmacopoeial Practices Guideline and Background of its Preparation
Kyoichi TADANOToru KAWANISHI
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JOURNAL FREE ACCESS

2017 Volume 7 Issue 3 Pages 185-196

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Abstract

After discussion at the International Meeting of World Pharmacopoeias from 2012, in May 2016, the WHO announced and published the Good Pharmacopoeial Practices (GPhP) guideline which is briefly describing the role and significance of existence of pharmacopoeia, basic philosophy of creating pharmacopoeia’s monographs for API, excipients and final drug products, notes, contents of composition, procedures of preparation etc. at a high level. In order to promote dissemination to the stakeholders of the Japanese Pharmacopoeia and to make use of it, we will report on the background of its preparation of this guideline, contents of description, points to be noted and future issues.

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© 2017 Society for Regulatory Science of Medical Products
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