Pharmaceutical Engineering Articles
Articles published in Pharmaceutical Engineering, ISPE’s bi-monthly member magazine that relate to the
subject matter of the Containment COP.
- FDA GMP Compliance Spotlight Will Remain Centered on
Conventional Aseptic Processing ( 536 KB)
At the ISPE 2012 Aseptic Conference in Tampa, a panel of FDA compliance experts provided important insights
on the continuing agency concern with manufacturers that use conventional aseptic processing and can’t
demonstrate that the heightened risks of the old technology are under control.
This article is an in-depth review of the dialogue that took place at the panel session, written by Bill
Paulson, Editor-in-Chief of International Pharmaceutical Quality, and originally appearing in IPQ's April
Monthly Update. The review was made available to ISPE through a special arrangement with IPQ.
Indicates content available to ISPE members only.