The Q&A for Q8/Q9/Q10 was created by the ICH Q-IWG and was issued in 2009. It was revised as R5 on October 30th 2024.
Since its initial release, there have been some revisions to the current version, such as revisions to Q9 and some aspects that have become outdated. You can see the updated items are indicated as “Oct. 2024” and most changes are editorial.
Below is a list of the major changes:
| RTRT No.5 (latter part added) | The added intention is that RTRT is exerted under specific circumstances (in this case, in the sense of an individual product) when the CPP and the attributes of the raw materials are combined. |
| PQS No.1 (the last bullet added) | Added the effect of knowledge-driven and objective risk assessment ⇒ from the perspective of Q9(R1) |
