definiens: means all applicable Good Manufacturi ng Practices including, as applicable, ( a ) the principles detailed in the U.S. Current Good Manufa cturing Practices, Title 21, Parts 210, 211, 601 an d 610 of the CFR, ( b ) the applicable part of quality assurance t o ensure that products are consistently produced an d controlled in accordance with the quality standards appropriat e for their intended use, as defined in European Co mmission Directive 2003/94 / EC laying down the principals and guidelines of good manufacturing practice, ( c ) the principles detailed in the ICH Q7A guidelines, ( d ) the Rules G overning Medicinal Products in the European Communi ty, Volume IV Good Manufacturing Practice for Medicinal Products, and ( e ) the equivalent Applicable Laws i n any relevant country, each as may be amended and applic able from time to time