definiens: / shall mean the standards established by the United States Food and Drug Administration ( the ) for current Good Manufac turing Practices, as specified in FDA 21 Code of Federal Regulations § 211 Current Good Manufactur ing Practice for Finished Pharmaceuticals ( or its successor provisions ) ; the standards * * * * Confidential Treatment Requested BI RCV Contract No : 39242 4 / 88 Confidential Execution copy established in the International Conference on Harm onization Guideline Q7 ; the standards established in the Rules Governing Medicinal Product in the Eur opean Union Volume 4 - Good Manufacturing Practices ( or its successor provisions ) ; the standa rds establish in Annex 2 – Manufacture of Biologica l Medicinal Products for Human Use ; and other section s so designated by the title as applicable to each respective Produc t(s ) or Drug Substance to be manufactured and/or supplied by BI RCV, it being recognized that cGMPs exist within the US Code of Federal Regulations separately for drugs ( Title 21 Part 211 )