Why Pharmacopoeia Compliance Is Difficult (eBook)

Pharmacopoeia Compliance Series

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.

Read this article in BioPharm International’s September 2019 Regulatory Sourcebook.

Article Details

BioPharm International
eBook: Regulatory Sourcebook, September 2019
September 2019
Pages: 26–34

Citation

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).