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 is part of a series that will be published in 2019–2020. 

, September 2019
	September 2019
	Pages: 36–42

	When referring to this article, please cite it as J.M. Wiggins and J.A. Albanese, “Why Pharmacopoeia Compliance Is Difficult," 

Pharmaceutical Technology Regulatory Sourcebook

Compendial Compliance

Pharmacopoeial Compliance Series

Quality Systems

Regulatory/GMP Compliance

Regulatory/GMP Compliance, Emerging Markets

Regulatory/GMP Compliance, Europe

Pharmaceutical Technology-09-15-2019

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.