Complications in Process Simulation Execution

May 15, 2020
James P. Agalloco

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.

Pharmaceutical Technology, Pharmaceutical Technology-05-15-2020, Volume 2020 eBook, Issue 2
Page Number: 10–14, 43

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.

Article Details

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).