ICH Q9(R1), Quality Risk Management, reached Step 4 of the revision process on 18 Jan 2023… a very timely current event for our discussion this week! This is the first time ICH Q9 has been updated since 2005. Consider the advancements in technology and science that have occurred during that 18 year span of time… and the risks associated with those novel inventions.
For this week’s CTA, please address the following questions in relation to ICH Q9:
Compare and contrast the original ICH Q9 Links to an external site.document to the newly revised ICH Q9(R1) Links to an external site.document. What are the similarities and differences between these two documents?
Select a relatively new or novel product of your choice that aligns to the scope of ICH Q9 — you may go broad in terms of drug/biologic class (i.e. cell and gene therapy, mRNA vaccine, PDL-1 inhibitor, etc.), or narrow to a specific product that is on the market (i.e. Lynparza, Comirnaty, etc.) — whichever approach you prefer.
For your selected product, consider how it is manufactured, stored, distributed and/or administered to patients. What are the risk factors of the product?
Does the revision of ICH Q9 adequately address the risks of this novel product? Why or why not?
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