James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.
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.
Pharmaceutical Technology eBook: Biologics and Sterile Drug Manufacturing May 2020 Pages: 10–14, 43
Citation
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).
