definiens: or means all applicable standards relating tomanufacturing practices for fine chemicals, active pharmaceutical ingredients, intermediates, bulk products or finishedpharmaceutical products, for supply in a given country or group of countries including : ( a ) in the case of the EuropeanUnion, ( i ) Directive 2003/94 / EC or any other applicable European Community legislation or regulation from time to time, and ( ii ) the Rules Governing Medicinal Products in the European Community, Volume IV Good Manufacturing Practice forMedicinal Products, each as may be applicable and as amended from time to time ; ( b ) in the case of the U.S., the principlesdetailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 210, 211, 601 and 610, each as may be applicableand as amended from time to time ; ( c ) in relation to any other country, the equivalent Laws in that country as amended andapplicable from time to time ; and ( d ) the principles detailed in the ICH Q7A guidelines