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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.
For the bio/pharmaceutical industry, compliance with requirements published by pharmacopoeias around the world is a legal and regulatory requirement in those countries and regions in which the pharmacopoeia is applicable.
This article provides a comprehensive, end-to-end framework to help companies involved in the development, manufacture, and distribution of small-molecule drug products, biotherapeutic products, and vaccines-as well as the drug substances and excipients used in these products-to better understand the external and internal challenges that make pharmacopoeia compliance difficult.
This article part of a series that will be published in 2019–2020. View all articles in this series.
eBook: Regulatory Sourcebook, September 2019
When referring to this article, please cite it as J.M. Wiggins and J.A. Albanese, “Why Pharmacopoeia Compliance Is Difficult," BioPharm International Regulatory Sourcebook eBook (September 2019).