ICH: Final Publication of Revised ICH Q9 Guideline
The International Council for Harmonisation (ICH) published a revised version of its Q9 guideline on 20 January, updating the original guideline, which is now 18 years old.
It covers the principles of quality risk management (QRM), the general QRM process, the QRM methodology and the integration of QRM into industry and regulatory processes. It also includes two annexes on QRM methods and tools and another on possible applications of QRM.
The final version has hardly changed from the draft published in December 2021 (we reported).
Source:
ICH: News
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