definiens: shall mean all applicable standards rela ting to manufacturing practices for fine chemicals, active pharmaceutical ingredients, intermediates, b ulk products or finished pharmaceutical products, i ncluding ( i ) the principles detailed in the U.S. Current Goo d Manufacturing Practices, 21 C.F.R. Parts 210 and 211 and The Rules Governing Medicinal Products in the Europ ean Community, Volume IV Good Manufacturing Practice for Medicinal Products as each may be amen ded from time to time, ( ii ) the principles detailed in the ICH Q7A guidelines, ( iii ) laws promulgated by any g overnmental authority having jurisdiction over the manufacture of Compound or Licensed Product within the Territory, and ( iv ) publicly available guidance documents promulgated by any governmental authority having jurisdiction over the manufacture of Compou nd or Licensed Product ( including but not limited to p ublicly available advisory opinions, compliance pol icy guides and guidelines ), which guidance documents are being implemented within the pharmaceutical manufacturin g industry