definiens: GMP " means eum : nt Good ManufllCturing Practices and standards II ! ! provided for ( and II ! ! amended from time 10 time ) in European Community Directive 91/)561EEC ( Principles W1d Guidelirocs of Good MUllufac turing Practice for Medicinal Products ) and in the CUITt'IU Good Mnnufocturing Practice Regulations of the United States Code of Federal Regulations Title 21 ( 21 CFR § § 210 - 211 ) in relation to the prodlll : tion of pharmaceutical intermediates and active phamlaceutical ingredients, II ! ! interpreted by ICH Hnrmonized Tripl!rtite Guideline . Good MAnufucturing Practice Guide for Active Phnrmaceuticnl Ingredients . and subject to any IIlT1mgcme nU, additions or clari lieations agreed from time to time between the Panics, 1.21 means ! lart·ScuIl·Radioo Antitrust Improvement Act of 1976, as ~ "