definiens: or means the then - current standards for themanufacture of pharmaceutical products, pursuant to ( a ) the FD&C Act ( 21 U.S.C. 321 et seq . ) ; ( b ) relevant United Statesregulations in Title 21 of the United States Code of Federal Regulations ( including Parts 11, 210, and 211 ) ; ( c ) EC Directive2003/94 EC of October 8, 2003 ; ( d ) the EC Guide to Good Manufacturing Practice for Medicinal Intermediate Products ; ( e)the International Conference on Harmonization ( ICH ) ICH Q7A Good Manufacturing Practice Guidance for ActivePharmaceutical Ingredients ; ( f ) any Japanese laws, rules, guidelines, or regulations corresponding to the subject matter of theforegoing ; and ( g ) all additional Regulatory Authority documents or regulations that replace, amend, modify, supplant orcomplement any of the foregoing