Section 19.1 states, “the controls used in the manufacture of APIs for use in clinical trials should be consistent with the stage of development”. This statement recognized that during development a synthetic process is often not finalized and the dose form is certainly still under development. With this broad backdrop, in order to adequately cover GMP issues, the EWG provided very general guidelines so that they could be applied across a poorly defined development timeframe for an API. Our attempt here was to identify the exceptions. If you look at the opening paragraph Section 19, we basically say that. We did not try to make it an all-inclusive chapter; we tried to explain where flexibility or where certain sections were not applicable. We were not writing a “how to” document. Good judgment had to apply.
