definiens: shall mean the current regulatory requirements fo r Good Manufacturing Practice pursuant to : ( a ) the U.S. Federal Food, Drug, and Cosmetic Act as amende d ( 21 USC 301 et seq . ) ; ( b ) U.S. regulations in Tit le 21 of the U.S. Code of Federal Regulations Parts 210, 211, 600 and 610 ; ( c ) the equivalents thereof in Canad a ; ( d ) Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2015 part II : Basic Requirements for Active Substances used as Starting Materials ; ( e ) I nternational Conference on Harmonization ( ICH ) Guid ance for Industry Q7 Good Manufacturing Practice Guidanc e for Active Pharmaceutical Ingredients ; and ( f ) Di rective 2003/94 / EC of 8 October 2003 laying down the princi ples and guidelines of good manufacturing practice in respect of medicinal products for human use and inv estigational medicinal products for human use and t he European Commission 's guidelines, Volum e 4,, in e ach case including successor laws, regulations or guide s