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36 BioPharm International eBook March 2020 www.biopharminternational.com Pharmacopoeia Compliance: Putting it All Together; What Is on the Horizon This article summarizes all the considerations that go into a company's compendial affairs program and looks ahead at topics that will likely result in further evolution in the pharmacopoeias around the world. C ompliance w ith requirements pub - lished by pharmacopoeias around the world is a legal and regulatory require- ment in those countries and regions in which the pharmacopoeia is applicable. This fundamental principle of pharmacopoeia com- pliance has been explored throughout this series of articles intended to bring greater visibility and under- standing to the bio/pharmaceutical industry, where compendial processes are not always well understood (1–11). The articles present many facets of the pro- cesses, people, and tools needed for a company to comply with the pharmacopoeia as well as their prod- uct registrations. The articles reflect the continuing evolution of the pharmacopoeias, their requirements, and the need for harmonization to achieve truly global pharmacopoeia standards. This final article in the series has two purposes: to summarize all the considerations that go into a com- pany's compendial affairs program and to look ahead at topics that will likely result in further evolution in the pharmacopoeias around the world. This look into what is on the horizon is important to help companies prepare for the inevitable changes and ensure the con- iQoncept - Stock.adobe.com J. MARK WIGGINS is owner and compendial consultant with Global Pharmacopoeia Solutions LLC. JOSEPH A. ALBANESE is the director of Analy tical Strategy and Compliance at Janssen Research and Development, LLC. J. MARK WIGGINS AND JOSEPH A. ALBANESE Regulatory Sourcebook Pharmacopoeia Compliance Series