definiens: shall mean all applicable standards relating to current Good Manufacturing Practices for fine chemicals, API, intermediates, b ulk products or finished pharmaceutical products, i ncluding without limitation ( i ) the principles detailed in t he Act at 21 U.S.C. 351(a)(2)(B ), in U.S. FDA regul ations at 21 C.F.R. Parts 210 and 211 and in The Rules Governing Medicinal Products in the European Community, Volu me IV, Good Manufacturing Practice for Medicinal Produ cts, ( ii ) the principles detailed in ICH Guidelines relating to the manufacture of API and finished pharmaceutic als, ( iii ) Laws promulgated by any Governmental Aut hority having jurisdiction over the manufacture of compoun ds or Licensed Products or any components of either of the foregoing, or ( iv ) guidance documents ( including ad visory opinions, compliance policy guides and guide lines ) promulgated by any Governmental Authority having ju risdiction over the manufacture of compounds or Licensed Products, which guidance documents are bei ng implemented within the pharmaceutical manufactur ing industry