APIs in clinical trial material – I fail to see the logic of employing a use test to release raw materials. If you use a material without some form of analysis and it turns out to be contaminated, the yield of your reaction may be what you expect, but the contaminant may still be present and go undetected by your analytical method for the API or Intermediate.

What was said in the presentation is that in some cases a use test may be most appropriate. You may also do traditional analytical testing, but often with a new process, a use test can be more meaningful. For example, you have a new raw material. The supplier sends you a Certificate of Analysis. You don’t know what the appropriate limits are; you don’t know whether it’s going to work or not. You’re using it; that’s part of the development work, part of the information. Certainly nothing in Q7A would ever prohibit a person from doing whatever analytical work they thought was appropriate.