definiens: ( abbreviated or ) shall mean the standards established by the United States Food and Drug Administration ( the ) for current Good Manufacturing Practices, as specified in FDA 21 C.F .R. § 211 Current Good Manufacturing Practice for Fi nished Pharmaceuticals ( or its successor provisions ) and F DA 21 C.F.R. § 820 Quality Systems Regulations ( or i ts successor provisions ) ; the standards established in the European Council Directive 2004/27 / EC of 31 March 2004 concerning medicinal products for human use, as amended ( or its successor provisions ) ; and other sections so designated by the title ; and further specified in the Inter national Committee on Harmonization ( 1CH ) Q7 guideline ( or its successor provisions ) ; and fur ther specified in the International Pharmaceutical Excipients Council ( IPEC ) and the Pharmaceutical Quality Group ( PQG ) for current Good Manufacturing Practices for Pharmaceutical Excipients, as specified in the 2006 Guide ( or their successor provisions )