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News|Articles|September 15, 2019
- Pharmaceutical Technology-09-15-2019
- Volume 2019 eBook
- Issue 2
Global Pharmacopoeia Standards: Why Harmonization is Needed (eBook)
Author(s)J. Mark Wiggins, Joseph A. Albanese
In this series of articles, the authors provide an understanding about the need for pharmacopoeia compliance and practical guidance to assist those who perform this work.
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Pharmacopoeia Compliance Series
Pharmacopoeias are embedded within the current regulatory and legal framework of the country or region in which they are applicable. The intersection of the pharmacopoeias and regulatory agencies impacts the direction and approaches taken to move toward harmonization at a global level.
Pharmacopoeia harmonization provides better support for global regulatory agencies and addresses the global nature of bio/pharmaceutical manufacturing and supply, which ultimately benefits global patients who rely on these medicines to extend and improve their lives. This article provides some industry perspective on the need to harmonize compendial standards, which may be helpful in considering the future direction of pharmacopoeias.
This article is part of a series that will be published in 2019–2020.
Article Details
Pharmaceutical Technology
eBook: Regulatory Sourcebook, September 2019
September 2019
Pages: 43–47
Citation
When referring to this article, please cite it as J.M. Wiggins and J.A. Albanese, “Global Pharmacopoeia Standards: Why Harmonization is Needed," Pharmaceutical Technology Regulatory Sourcebook eBook (September 2019).
Articles in this issue
about 7 years ago
What’s New in Regulations and Complianceabout 7 years ago
Quality Culture Drives Patient Confidence in Drug Productsabout 7 years ago
Generics: Getting Beyond “File First, Figure it Out Later”about 7 years ago
Why Pharmacopoeia Compliance Is Difficult (eBook)about 7 years ago
Why Pharmacopoeia Compliance Is Necessary (eBook)about 7 years ago
Resources, Guidelines, and Guidance Documentsabout 7 years ago
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