definiens: or means the then -current standards for the manufacture of pharmaceutical products, pursuant to ( a ) the FD&C Act ; ( b ) relevant United States regulations in Title 21 of 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 ) International Conference on Harmonization ( ) ICH Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients ; ( f ) MHLW Ministerial Ordinance No . 179, 2004, MHW Ministerial Ordinance No . 2, 1961, and GMP Guideline for Drugs and Quasi -Drugs ( Drug Products ) 2005 and ( g ) all additional Regulatory Authority documents or regulations that replace, amend, modify, supplant or complement any of the foregoing