Regulators have exaggerated expectations for simulated media fills.
Regulators have exaggerated expectations for simulated media fills.
This article reviews aspects of media fill execution in which regulatory expectations have created artificial compliance concerns and significant practical difficulties.
Read this article in Pharmaceutical Technology's Biologics and Sterile Drug Manufacturing eBook.
Pharmaceutical Technology
eBook: Biologics and Sterile Drug Manufacturing
May 2020
Pages: 10–14, 43
When referring to this article, please cite it as J. Agalloco, "Complications in Process Simulation Execution," Pharmaceutical Technology Biologics and Sterile Drug Manufacturing eBook (May 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.