definiens: or means t hen - current standards for the manufacture of pharmaceutical products, pursuant to ( a ) the FD&C A ct ( 21 U.S.C. 321 et seq . ) ; ( b ) relevant United Sta tes regulations in Title 21 of the United States Code o f Federal Regulations ( including Parts 11, 210, and 211 ) ; ( c ) European Community Directives 2003/94 and 91/356 / EC ; ( d ) the European Community Guide to Good Manufacturing Practice for Medicinal Intermediate P roducts ; ( e ) ICH Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients ; ( f ) equivalent Laws of an applicable Regulatory Author ity at the time of Manufacture ; and ( g ) all additional Regulat ory Authority documents or regulations that replace, amend, modify, supplant or complement any of the foregoing