“The guideline complements the ICH Quality Guidelines Q8 - Q11, aims to promote innovation and continual improvement in the pharmaceutical sector and strengthens quality assurance and reliable supply of product, including proactive planning of global supply chain adjustments” the ICH says.
Furthermore, the Assembly approved concept paper outlines for two topics raised at its previous meeting in Amsterdam last June:
The start time for a revision of ICH Q9 will be delayed in view of other ongoing quality work.
A new Working Group is now being established to initiate work on the new topic proposal on ICH Q3E Guideline Impurity: Assessment and Control of Extractables and Leachables for Pharmaceuticals and Biologics.
Several new Working Groups also advanced work in Singapore on their respective new topics with the finalisation of Concept Papers and Business Plans on:
The next ICH meeting will take place on 23-27 May 2020 in Vancouver, Canada.
ICH: Press Release
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