definiens: means current good manufacturing practice and stand ards as provided for ( and as amended from time to time ) in the current Good Manu facturing Practice Regulations of the U.S. Code of Federal Regulations Title 21 ( 21 C.F.R. § § 210 and 211 ) and in the European Community Directive 91/356 / EEC ( Pri nciples and guidelines of good manufacturing practice for m edicinal products ) in relation to the manufacture o f pharmaceutical products and production of finished pharmaceutical products, as interpreted by ICH Harm onised Tripartite Guideline, Good Manufacturing Practice G uide for Active Pharmaceutical Ingredients, Q7a, an d similar requirements of other Regulatory Authorities in jur isdictions outside the United States and the Europe an Union, and subject to any arrangements, additions or clari fications, and the respective roles and responsibil ities, agreed from time to time between the Parties