definiens: means then - current standards for the Manufacture of pharmaceutical products, pursuant to : ( a ) the FDCA ( 21 U.S.C. § 321 et seq . ) ; ( b ) relevan t United States regulations in Title 21 of the Unit ed States Code of Federal Regulations ( including Parts 11, 21 0, and 211 ) ; ( c ) European Community Directives 2003 /94 and 91/356 / EC ; ( d ) the European Community Guide to Good Manufacturing Practice for Medicinal Intermedi ate Products ; ( e ) ICH Q7A Good Manufacturing Practice G uidance for Active Pharmaceutical Ingredients ; ( f ) analogous Applicable Laws of an applicable Regu latory Authority at the time of Manufacture ; and ( g ) all additional Regulatory Authority documents or regula tions that replace, amend, modify, supplant, or com plement any of the foregoing