Impact statement Annex 1

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Presentation transcript:

Impact statement Annex 1 Malcolm Holmes January 2017

Background Previous EU Annex 1 New EU Annex 1 Risk First issued in 1972 Number of revisions since then 1996, 2003, 2005, 2007 and 2009, but not full revisions. 2012 first proposal to fully revise - Proposal Re-issued in 2014 Final version now expected Q1 2017. New EU Annex 1 Will remove ambiguities and hangovers from previous versions which are no longer appropriate in the light of new technologies and expectations. Quality Risk Management /New technologies:/ Reinforces need for manufacturers to implement current technologies (Single use closed systems / Disposable systems / Innovative technologies, processing and testing Risk Are your facilities, processes and practices up to the new expectation. For a revision to take this long to come through the system it must involve significant change.

Why Anomalies and outmoded practices removed Gathering & interpretation of environmental data Inspectional observation s New technologies available Raised regulator awareness

Potential Impact Increased patient safety Existing practices may no longer be valid Reinforced need to keep up with technology Maintenance of skills and knowledge Global acceptance? Act now or face regulatory censure Company reputation