Interviews, Smart Manufacturing

MSD: Keeping Batch Records compliant


Kurt Van der Aa
Senior Specialist IT-Compliance EMEA, MSD

we.CONECT Market Research & Intelligence met Kurt Van der Aa, Senior Specialist IT-Compliance EMEA, MSD to talk about MES applications and how to safeguard batch record compliance. Kurt Van der Aa is responsible for IT Risk Management and Security Regional Lead for computerized systems within EMEA and MES worldwide within Merck/MSD. Over 16 years of experience in Pharmaceuticals, held various positions and roles within Technical, Quality and IT Unit. Actively involved in overall regulatory compliance and inspection readiness of IT, Shopfloor and Lab Automation capabilities within the Manufacturing and Supply Chain function of Merck & Co for EMEA. Kurt has a degree in Electronics and Automation Engineering.

In which stage of MES implementation are you?

Kurt Van der Aa: We have a validated centrally managed MES core application. This is duplicated for local installation at multiple production sites. We are preparing for major upgrade of the core system over the next 2 years.

In your opinion, how will MES influence the workplace of the future (mobile devices, HMI, internet of things, data analysis)?

Integration of MES into the Shopfloor will take away paper, therefor having the opportunity to implement Review by Exception. i.e. only in case of incidents, batch records will be reviewed. Otherwise very limited review is done to release batches.

Do you use MES technology to comply with serialization requirements?

At our company we separated MES records and serialization activities, as the technology and the regulations are not stable yet. Technically the throughput, communications and data flows for serialization activities are much higher than the follow-up of a production order in general, this requiring specific hardware to manage the serialization records.

What are specific MES requirements for emerging markets?

Production batches become shorter and shorter all the time, to minimize stock and to maximize personalization of the product up to patient level. This will give extra challenges to very flexible switch between batches of very little units.

Which areas of your production work with MES?

Packaging, formulation, weighing and dispensing.

Which department was in charge in regards to vendor selection and implementation?

The IT and Quality groups performed vendor assessments. The outcome of this assessment drove the selection for the best vendor to work with.

Which MES project are you currently working on?

MES projects in MSD Oss (the Netherlands) and MES Mirabel (France).

Thank you very much for this interview!

Interview partners: Kurt Van der Aa and Josefin Fügener.