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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, firstname.lastname@example.org. He is also a member of Pharmaceutical Technology’s editorial advisory board.
September 02, 2021
Microbial experts should employ proactive practices on the manufacturing floor, rather than relying on testing.
May 15, 2020
Regulators have exaggerated expectations for simulated media fills.
May 15, 2019
Quality cannot be verified through testing, especially at the limit of detection, and no test method can confirm the absence of a microbe or particle.
A one-size-fits-all approach to monitoring practices and results is never appropriate, given the diversity of practice within the pharmaceutical industry.