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December 15, 2019
The process used to monitor and participate in pharmacopoeial changes is described.
Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.
Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.
September 15, 2019
In this series of articles, the authors provide an understanding about the need for pharmacopoeia compliance and practical guidance to assist those who perform this work.
While overall industry performance is trending positive, quality failures continue to negatively impact patients and the bio/pharma industry.
August 29, 2019
While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.
June 01, 2019
FDA’s annual manufacturing report card shows more quality compliance is needed.
Proactive approaches that consider long-term supply chain security compliance are recommended to ensure companies stay on the right track.