definiens: means current standards for the manufacture of pharmaceutical products, pursuant to ( a ) the FDCA, ( b ) relevant United Statesregulations in Title 21 of the United States Code of Federal Regulations ( including Parts 11, 210, 211 and 600 ), ( c ) European CommunityDirectives 2003/94 and 91/356 / EC, ( d ) the European Community Guide to Good Manufacturing Practice for Medicinal Intermediate Products,(e ) ICH Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients and all other quality guidelines issued by the ICH,(f ) analogous applicable Laws of an applicable Governmental Entity at the time of manufacture of Products for nonclinical, clinicalinvestigational or clinical trials, or marketing, and ( g ) all additional Governmental Entity documents or regulations that replace, amend, modify, supplant or complement any of the foregoing from time to time