definiens: means the current good manufacturing practices for the manufacture of pharmaceutical product s, including without limitation : ( a ) the United States Federal Food, Drug, and Cosmetic Act, as amended ( 21 U.S.C. § 321 et seq . ) and the regulatory requirements for current good manufacturing practices as promulgated by the FDA thereunder ; including withou t limitation 21 C.F.R. Part 11 ( as applicable to electronic systems used in the manufacture of Product ), 21 C.F.R. Parts 210 and 211 as amended ; and ( b ) the regulatory requirements for current good manufacturing practices as promulgated by the Internationa l Conference on Harmonization ( ICH ) ; and ( c ) Guidance for Industry Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients ; and/or the European Community Directive 2003/94 / EC of October 8, 2003 ; and ( d ) the EC Guide to Good Manufactu ring Practice for Medicinal Intermediate Products ; and ( e ) 2003/94 / EEC Directive ( as supplemented by Volume 4 of EudraLex published by the European Commission ), as amended, if and as implemented in the relevant constituent country ; and ( f ) all additional R egulatory Authority documents and regulations that replace, amend, modify, supplant or complement any of the foregoing and any amendments to the foregoing ; and ( g ) any and all current Good Manufacturing Practices applicable to the manufacture, testing and/ or any other processing of pharmaceutical products in other countries and territories worldwide where the respective Final Products are sold or otherwise marketed from time to time provided that [COMPANY] is informed about such other Good Manufacturing Practices by [COMPANY] in accordance with the Quality Agreement within a reasonable time so as not to delay release of the Final Product