definiens: means the current good manufacturing practices for the manufacture of pharmaceutical products, includi ng 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 without limitati on 21 C.F.R. Part 11 ( as applicable to electronic systems used in the manufacture of Product ) ; and ( b ) the regulatory requirements for current good manufacturing practices as promulgated by the International Conference on Harmonization ( ICH ), Guidance for Industry Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients ; and ( c ) the European Community Directive 2003/94 / EC of October 8, 2003 ; and ( d ) the EC Guide to Good Manufacturing Practice for Medicinal Intermediate Products ; and ( e ) the regulatory requirements for current good manufacturing practices as promulgated by the NMPA or other equivalent Regulatory Authority in the PRC ; and ( f ) Good Quality Practices ( GQP ) for Marketing Authorization Holder under MHLW Ministerial Ordinance No.136 on Standards for Quality Assurance of Drugs, Quasi -drugs, Cosmetics and Medical Devices ( established as of September 22, 2004 ) ; and ( g ) MHLW Ministerial Ordinance No . 179 on Standards for Manufacturing Control and Quality Control of Drugs and Quasi -drugs ( revised as of December 24, 2004 ) ; and ( h ) all additional Regulatory Authority documents and regulations that replace, amend, modify, supplant or complement any of the foregoing and any amendments to the foregoing, including those specified in the Qu ality Agreement ; and ( i ) 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 sol d or otherwise marketed from time to time provided that STA is informed about such other Good Manufacturing Practices by [COMPANY] in accordance with Quality Agreement prior to the manufacture of such Products so as not to delay release of the Final Product