Pharmaceutical Engineering Knowledge Brief: How to Determine Rouge Limits to Initiate
Derouging and Passivation
by Nissan Cohen
Download the Knowledge Brief
The pharmaceutical industry has been concerned about rouge for many years. This Knowledge Brief, written
by internationally renown pharmaceutical water systems expert Nissan Cohen, explores how previous approaches
to determining rouge limits and derouging and passivation strategies have been unscientific and prophylactic
in nature, and outlines methods for using real science in these processes. Once you've read the Knowledge
Brief, share your views in the comments on the related
post over at ISPEAK, ISPE's official blog.
Whitepaper: ISPE Proposals for FDA Quality Metrics Program
by the ISPE Quality Metrics Working Group
ISPE has been leading the charge to bring industry and regulators together to discuss quality metrics ever
since the US FDA first brought the subject to the forefront of industry thinking in the Food and Drug
Administration Safety and Innovation Act (FDASIA). At the request of FDA, the ISPE Quality Metrics working
group has developed a whitepaper on potential measures of product quality, site operations quality and site
systems performance. The recommendations contained in the paper stem from robust industry-FDA discussions
facilitated by ISPE’s Quality Metrics working group. Download the paper to read the group's recommendations
for current and future steps to help implement this critical FDASIA initiative.
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