Commission Regulation (EC) No. 2023/2006 on good manufacturing practice (GMP) applies to those materials and articles within the scope of Regulation (EC) No. 1935/2004. It lays down the detailed principles to be incorporated into GMP protocols to ensure uniformity & conformity amongst member states across the EU. The new Regulation enters force on 18 January 2007 & shall apply from 1 August 2008 and is directly applicable in all EU Member States; Defines BMP to ensure that materials & articles are consistently produced & controlled & conform with the rules applicable to them & with the the quality standards appropriate to their intended use; Will apply to all sectors & all states of manufacture, processing & distribution of materials & articles (rules set out in the Annex shall apply oto the relevant individually mentioned materials & processes); Delays the application of the EC Regulation until 1 Aug/08 to enable businesses reasonable time to establish the QC systems & procedures necessary to demonstrate compliance.
