The International Council for Harmonisation (ICH) has adopted a revised version of its Q9 guideline that aims to improve current quality risk management (QRM) programs by creating more objective risk ...

The International Council for Harmonization (ICH) issued a revision of the Q9 guideline that aims to address the shortcomings of the current guideline. The goal of the revision is to provide “more ...

A change in terminology could emphasize patient protection. The current International Conference on Harmonization (ICH) Q9, Quality Risk Management guideline was recommended for adoption by the three ...

The recent revision is intended to provide guidance on QRM principles and tools that can be used for different aspects of pharmaceutical quality. FDA announced the publication of a final guidance for ...

There are many ways to do risk assessment, says Elaine Morefield of the FDA during this week's ISPE conference. Failure mode and effects analysis (FMEA) and fishbone diagrams are among them. "Q9 of ...