This webinar provides a broad overview of ICH Q10, The Pharmaceutical Quality System. ICH Q10 is applicable throughout the pharmaceutical lifecycle. Unlike the FDA Quality Systems Approach limited ...
An important aspect of a pharmaceutical company is a robust quality management system (QMS) because it shows the company’s commitment to quality. This idea was introduced by the International ...
In 2020, the International Council for Harmonisation (ICH) published a concept paper (1) that outlined a limited revision to the published guideline ICH Q9 Quality Risk Management (QRM) (2) to address ...
ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, announced that it will release GAMP Good Practice Guide: A Risk-Based Approach to GxP ...
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