definiens: or means the then - current good manufacturing practic es, standards, guidelines and regulations promulgated and published by the FDA, E MA and such other jurisdiction agreed upon by the P arties in writing, relating to the testing, manufacturing, processing, packaging, holding or distribution of drug substances and finished drugs including any standards, guideli nes and regulations as promulgated by, as applicabl e : ( a ) the FDA under and in accordance with the U.S. Federal F ood, Drug and Cosmetic Act and Title 21, Parts 210 and 211 of the U.S. Code of Federal Regulations, ( b ) the EM A and the EU Commission under European Directive 2003/94 / EC, and/or ( c ) the ICH Harmonised Tripartit e Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients ( ICH Q7 ), as such standa rds, guidelines and regulations may be amended from time to time