Pharmacopoeia Compliance: Putting It All Together; What Is on the Horizon (eBook)
This final article in the series has two purposes: to summarize all the considerations that go into a company’s compendial affairs program and to look ahead at topics that will likely result in further evolution in the pharmacopoeias around the world.
Pharmacopoeia Compliance Series
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 final article in the series has two purposes: to summarize all the considerations that go into a company’s compendial affairs program and to look ahead at topics that will likely result in further evolution in the pharmacopoeias around the world.
This article is part of a series that will be published in 2019–2020. View all articles in this series.
Read this article in Pharmaceutical Technology’s March 2020 Regulatory Sourcebook.
Article Details
Pharmaceutical Technology
eBook: Regulatory Sourcebook, March 2020
March 2020
Pages: 34–42
Citation
When referring to this article, please cite it as J.M. Wiggins and J.A. Albanese, “Pharmacopoeia Compliance: Putting It All Together; What Is on the Horizon," Pharmaceutical Technology Regulatory Sourcebook eBook (March 2020).
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
