definiens: and means all applicable principles, guidelines and guidancefor current good manufacturing practice as found in : ( a)the International Conference on Harmonization of Technical Requirements for the Registration ofPharmaceuticals for Human Use ICH Tripartite Guideline Good Manufacturing Practice Guide for ActivePharmaceutical Ingredients Q7 ( also published as CPMP / ICH/4106/00, 10 November 2000 ) ; ( b)the applicable provisions of Directive 2003/94 / EC and further guidance as published by the EuropeanCommission in Volume 4 of The rules governing medicinal products in the European Union ; ( c)foreign equivalents of the foregoing ; and ( d ) all other legal provisions, regulations, decisions or guidance of competent authorities which areapplicable to any sites involved in the manufacture, quality control, quality assurance or supply of theInvestigational Medicinal Product