definiens: means the current good manufacturing practice s applicable to the Manufacturing of the Product, o r any intermediate of the Product, under Applicable L aw, including those promulgated under the FDA Act a t 21 C.F.R. ( Parts 210 and 211 and Part 4 as relevant for combination products ), Commission Directive ( EU ) 2017/1572 ( art . 2 ), together with the latest F DA, EMA and European Commission guidance documents pertaining to manufacturing and quality c ontrol practice, all as updated, amended and revise d from time to time . Guidance in draft status will be considered as in effect for the purposes of this d efinition if this guidance has been adopted by [COMPANY] at the Facility in relation to all its other clients and included as part of [COMPANY] ’s Standard Operating Procedures or if it is agreed to be adopted by the Commercial Steering Committee