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.
Pharmaceutical Technology
eBook: Regulatory Sourcebook, March 2020
March 2020
Pages: 34–42
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).
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.