Just to clarify the question, is the person talking about QA approval of completed records or QA approval of the instructions, because it really is two different things? QA always approves the release of materials, and that would be review of completed records. The question was related to the instructions, the manufacturing instructions. Section 19.9 states, “A system should be in place to ensure that information gained during the development and manufacture of APIs for use in clinical trials is documented and available”. Often, the very first clinical batches are being done in a laboratory and being recorded in a lab notebook, as opposed to having manufacturing instructions written out where you fill in the blanks. Frequently, your PhD chemists are running the process on a lab scale, at this point, and they are recording – hopefully, in a lot of detail – what they’re doing and what they’re observing. What we were trying to do here was, again, to recognize the real world of development. Section 19.2 states, “a quality unit(s) independent from production should be established for the approval or rejection of each batch of API for use in clinical trials”. It is pretty clear that you need to have a separate quality unit for the approval or rejection of each batch of API for use in clinical trials. But, it goes on to say that some of the testing functions commonly performed by the Quality unit under the rest of this document, could be done in the clinical API area by other functions. In other words, it’s very common for the R&D function in a firm to be doing the testing and releasing, or review and releasing, use testing and releasing of raw materials that they’re buying to use to make the synthetic material. And, it recognized that. It wasn’t going to be a violation, and it shouldn’t be a violation if that were happening.
