Clearly while development is underway and early phase clinical batches are being prepared, there is little experience for setting a pre-approval of specifications for intermediate starting materials and process parameters. This can lead to an unreasonable number of OOS investigations especially for the first batch. During this stage, would it be instead acceptable to the regulatory authority to gather information that can be used to assist future specification setting rather than require a hard pass/fail quantification of the materials used?

That’s typically exactly what’s done in the first batches. You are gathering the data to set the specifications that you will be testing against later on. (See sections 19.1 and 19.2) I asked that question because within our organization there’s a lot of debate about, when they can actually transfer the method and when, especially for stability studies, and the stability studies for the clinical materials not being conducted per the stability  program, within the stability database. One of the defenses to that was saying that the QC group unit wouldn’t be conducting that method until it was validated and appropriately transferred over to QC, so it’s residing within the analytical group. That could be a requirement within your own company, but that is not so stated in Q7A.