Definition-cGMP.txt

shall mean the highest standard of all then-current guidelines for Good Manufacturing Processes [i. e. for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, testing, packaging, labelling, handling or storage of a product to assure that it is safe, and has the identity and strength and meets the quality and purity characteristics that it purports, or is represented, to possess] (“GMP Guidelines”) in the Territory, in their latest applicable version. This term shall also include guidelines that are issued by either national or international bodies in the Territory and that are either explicitly or implicitly related to the GMP Guidelines such as e. g., the guidelines on statistics. [For countries which are members of the EU: The currently valid GMP guidelines include Directive 2003/94/EC and the corresponding implementation guidelines /// For US countries: The currently valid GMP guidelines include all guidelines pursuant to 21 C.F.R. §§ 210 and 211].