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Pharmaceutical Processing News
News Release from: SPECIAL REPORT by the Editor | Subject: Werum MES
Edited by the Processingtalk Editorial
Team on 04 June 2007
Werum 'MES in Pharmaceuticals' Day in
Ireland
Last week Werum Pharma held an MES presentation in Cork, to explain their approach to the paperless plant, with case studies from recent MES installations at Genzyme and Altana Pharma
Eoin O'Riain, of Read-out.net in Ireland attended the recent Werum presentation in Cork, and sends this report on an interesting day hearing about 'The Paperless Pharma Plant' - and two of them are being created now near Cork His report follows
This article was originally published on Processingtalk on 3 Aug 2004 at 8.00am (UK)
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Those of us involved in the automation and control function of our plants are sometimes blind to the other functions in getting the final end-product out of the door to our customer.
Werum highlighted this in a recent presentation in Cork, an explanation of Pharma MES, with the title "The Paperless Plant Has Arrived".
Even the organisers were surprised at the significant attendance, of over seventy five people, a veritable cross section of everybody who is anybody in the pharmaceutical manufacturing business in Ireland.
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Werum, based in Germany but represented in Ireland by Enterprise System Partners (ESP), has earned a considerable reputation over the years for the business expertise developed within a few key areas:.
* Production Management for Regulated Industries.
* Test Data Management Systems.
* Customised IT Solutions.
In this conference the main emphasis was for Werum to present an inside perspective on the benefits that have resulted from the MES projects recently completed in Ireland, and for the audience to learn from industry experts about what it takes to significantly improve the compliance and performance of pharmaceutical manufacturing processes.
Further expansions of the Werum PAS-X MES installations at Genzyme and Nycomed (formerly Altana) Pharma have recently been completed.
The MES functionality they implemented covers all essential manufacturing business processes as well as the integration of the MES with the existing automation and ERP layers.
The conference opened with a brief introduction and overview of MES by Liam O'Brien of ESP - a partner company with Werum in Ireland.
He dealt with the basics: What MES is, the factors influencing its selection, and the benefits.
Liam used a simple pyramid to show this: the base is the process automation and control in the plant, broadly based on events.
On top of that the integrated production management sector or MES is production or operation based.
This contains functions such as batch recording, material tracking, warehouse management etc.
Finally there's the ERP area which is controlling the sales and production planning, scheduling and procurement.
Simon Bragg of the ARC Advisory Group then outlined the future market trends, describing the best practices and the challenges that are forcing change in the pharmaceutical industry at an ever increasing rate.
In conclusion he felt that pharmaceutical manufacturing will move from a supply chain model to a value chain model; there is need for a new collaborative manufacturing approach incorporating manufacturing productivity improvement and a risk based approach to compliance; and enterprise CPM suites are key to enable value chain collaboration.
After all this theory it was time for the first "hands-on" discussion of what really happened on site.
First we had Graham Clarke and his team from the new Nycomed (formerly Altana) plant in Carrigtwohill, near Cork.
This was a fascinating study of the building of a plant from planning in 2003 to production mid 2006.
The most interesting part of this presentation, as of all such, was the slide entitled "Lessons learned!".
These included:.
* Use as many manufacturing personnel as possible in the qualification stage.
* The challenge of running start-up and the MES project in parallel should not be underestimated.
* Training of users in all transactions is vital.
Diarmuid Quinn, also of ESP, then outlined the path to a successful introduction of MES.
This covered planning and step-by-step progressing of the project: he concluded by listing key success factors such as.
* Correct product/vendor selection.
* Clear schedule (goals and time-lines).
* Communication.
* Management commitment.
* Project team resourcing and empowerment.
* Early definition of post go-live support model.
The second "practical" presentation was on the gWAP (genzyme Waterford Automation Programme) from Eamonn O Mathuna and Kevin Brady.
Again this was very interesting because this was a plant which already existed, and which wanted to move to paperless manufacturing in five major areas of the operation.
They described the initial planning, the people involved, their areas of expertise, and how the changes fitted into the pyramid described in the earlier presentation.
They went through the entire project, pointing out the milestones achieved and the results.
And as in the previous presentation a list of lessons learned was included.
This concluded with the statement "Ensure the paper goes!": This can be difficult as operators are so wedded to paper records that they may be loath to see them go!.
Finally the excellent day ended with a look into the future from Werum, which was summarised into a series of four statements:.
1) To fully achieve operational excellence and lean manufacturing strategies in pharmaceutical production you need independent, but integrated MES.
2) MES is a global roll-out manufacturing excellence strategy - no longer only a system.
3) The FDA paradigm change to QbD and PAT needs improved process understanding and control, managing the flexible design and control space by powerful product specifications in the MES.
4) In ten years time every pharmaceutical company will be operating totally paperless, with electronic batch recording (EBR) systems.
Finally the presentation finished with the Werum vision: "The only place in your plant that will still need paper - the rest room" (And he probably did not mean 'magazines in the tea room', it's probably the American expression - Editor).
All in all a very interesting day, well organised with plenty of breaks, long enough to both gather your thoughts and for discussion and interaction between participants and speakers.
Eoin O'Riain is Editor of the Read-out Instrumentation Signpost, Ireland's magazine and website for instrumentation and process engineers, see www.read-out.net .
PRs and other application stories from Werum Software and Systems can be found on http://www.processingtalk.com/news/wer/wer000.html .
For ESP (Enterprise System Partners) in Ireland see: www.esp.ie .
For ARC Advisory Group see: http://www.processingtalk.com/news/ajw/ajw000.html .
For Nycomed see: www.nycomed.com .
For Genzyme see: www.genzyme.com .
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