definiens: means the then - current Good Manufacturing Practic es standards, practices and procedures for the manufac ture, testing, quality assurance and quality contro l of pharmaceutical products including, as applicable, ( a ) those promulgated and endorsed by the FDA as set forth in 21 C.F.R. Parts 4, 210, 211, 601, 610 and 820, ( b ) European Directive 2003/94 / EC and Eudralex 4, ( c ) t he principles detailed in the WHO TRS 986 Annex 2, TRS 961 Annex 6 and TRS 957 Annex 2, ( d ) ICH Q7 guidelines and ( e ) comparable regulatory standards, practices and procedures promulgated by any other Regulatory Agency in any country in which a Product is intended to be sold, each as may be amended and applicable from time to time