definiens: or means the then - current standards for the manufacture ofpharmaceutical products, pursuant to ( a ) the FD&C Act ( 21 U.S.C. 321 et seq . ) ; ( b ) relevant United States regulations in Title 21of the United States Code of Federal Regulations ( including Parts 11, 210, and 211 ) ; ( c ) EC Directive 2003/94 EC of October 8,2003 ; ( d ) the EC Guide to Good Manufacturing Practice for Medicinal Intermediate Products ; ( e ) the International Conference onHarmonization ( ICH ) ICH Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients ; ( f ) any Japaneselaws, rules, guidelines, or regulations corresponding to the subject matter of the foregoing ; and ( g ) all additional RegulatoryAuthority documents or regulations that replace, amend, modify, supplant or complement any of the foregoing