Human or Animal Origin

studies should be conducted every 3 months during the first specifications will be established to determine the sucyear of storage, every 6 months during the second year, cessful completion of the manufacturing step before and annually thereafter. continuation of the manufacturing process. This inWhile the testing intervals listed above may be appropricludes material that may undergo further molecular ate in the preapproval or prelicense stage, reduced testing modification or be held for an extended period before may be appropriate after approval or licensure where data further processing. are available that demonstrate adequate stability. Where • Manufacturing Scale Production—Manufacture at the data exist that indicate the stability of a product is not comscale typically encountered in a facility intended for promised, the applicant is encouraged to submit a protocol product production for marketing. that supports elimination of specific test intervals (e.g., 9• Pilot-Plant Scale—The production of the drug substance month testing) for postapproval/postlicensure, long-term or drug product by a procedure fully representative of studies. and simulating that to be applied at manufacturing scale. The methods of cell expansion, harvest, and product purification should be identical except for the VIII. SPECIFICATIONS (8) scale of production.