definiens: means all applicable Good Manufacturing Practices including, if and as applicable, ( a ) the principles detailed in the U.S. Current Good Manufacturing Practices, Title 21, Parts 210, 211, 601 and 610 of the CFR, ( b ) the applicable part of quality assurance to 18406.115 - 901937 vi 4 Execution Copy ensure that products are consistently produced and controlled in accordance with the quality standards appropriate for their intended use, as defined in European Commission Directive 2003/94 / EC laying down the principals and guidelines of good manufacturing practice, ( c ) the principles detailed in the ICH Q7 A guidelines, ( d ) the Rules Goveming Medicinal Products in the European Community, Volume IV Good Manufacturing Practice for Medicinal Products, and ( e ) the equivalent Applicable Laws in any relevant country, each as may be amended and applicable from time to time