1. Impact statement Annex 1
Malcolm Holmes
January 2017

2. Background Previous EU Annex 1 New EU Annex 1 Risk
First issued in 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 Q
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.

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

4. 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