definiens: means the current good manufacturing practice s applicable from time to time to the Manufacturing of the Product, or any intermediate of the Product, pursua nt to Applicable Law, including those promulgated u nder the FDA Act at 21 C.F.R. ( Parts 210 and 211 and Part 4 as relevant for combination products ), and those pr omulgated under Directive 2001/83 / EC ( as amended by Directive 2004/27 / EC ), Directive 2003/94 / EC and EudraLex - Volume 4 of the Rules Governing Medicinal Products in the European Union entitled, together with the latest FDA, EMA and European Commission guidance documents pertaini ng to manufacturing and quality control practice, a ll as updated, amended and revised from time to time . Gui dance in draft status will be considered as in effe ct for the purposes of this definition if this guidance has be en adopted by [COMPANY] at the Facility in relation t o all its other clients and included as part of [COMPANY] ’s Standard Operating Procedures or if it is agreed to be adopt ed by the Commercial Steering Committee