外购，是 商业化的产品？还是 定制的产品？这两种需要提供的信息量应该是不一样的。

FDA Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals    

摘录内容 Accurate records should be kept of the composition and source of the cell culture medium. In cases where the manufacturer of a biological product uses a proprietary medium or medium supplement, the manufacturer of the medium or medium supplement may be required to Supply the necessary data directly to CBER, in the form, for example, of a Master File Application.