Compliance in the pharmaceutical supply chain

compliance-in-the-pharmaceutical-supply-chain

NGP talks to Nycomed’ s Barthold Piening about the challenges of ensuring compliance and operational excellence in the pharmaceutical supply chain.

We hear a lot about the impact of increased regulatory hurdles on the industry. Is this something that is affecting the manufacturing side?

Barthold Piening. This is something which keeps us pretty busy. It’s not just a problem with higher regulatory requirements coming from the FDA. We comply with the FDA guidelines – this is not our major challenge. The challenge is that, where we operate a lot with the focus on the emerging markets, but as well in Europe and the United States, we have to cover all different regulatory requirements in the world, and this gets increasingly complex. It is a little bit annoying that I do not see a trend to harmonization between the FDA and EMEA, and then all the emerging markets are coming up with their specific requirements.

And you have to cover them all. In markets like China and Russia, in my understanding, they have a completely different understanding of regulatory requirements compared to the standard FDA regulations, and this makes our life really complicated in order to satisfy all wishes of the world.

It’ s a challenge, and my conclusion is it gets more and more difficult to have just one standardized system – one size doesn’t fit all. You have to have tailor-made solutions.

What are the specific advantages and challenges of implementing an operational excellence program in the manufacturing supply chain?

BP. We have started our operational excellence program approximately two years ago in the conceptual phase, and we are now in the implementation phase, so we have gathered some first experience of the first project implemented.

The main advantage is that you can involve and motivate more or less all employees. It’ s not only an initiative for special projects at the management level; there is a huge potential for improvement across the whole organization. The key is how to ensure our employees contribute to this process.

We have invested a lot in the training and personal development of shop floor employees, and this was regarded as a major benefit for individual employees. We have now touched roughly 10 percent of our workforce, which is a lot, with education and training programs to get into operational excellence. We are starting now to see the fruits and to harvest from this campaign.

I would say the major barrier is not motivating the shop floor employees, it’ s more to overcome the management level resistance. People are so occupied with how they did it in the past, and readiness to change is sometimes tougher to achieve in the management higher rank rather than on the shop floor level. We have seen fantastic enthusiasm on the shop floor, where people are happy to get additional training, and then to apply what they have learned in real life projects immediately. This is perceived very positively.

In your organisation, you called your program ‘operational excellence’. Does that mean you’ re not using elements of Lean Six Sigma?

BP. We have decided not to use only one Lean methodology. We are a bit flexible. We apply Six Sigma; we apply Lean Six Sigma. We apply continuous improvement and 5-S Quality Management wherever it is feasible.

We don’ t want to apply just one tool. There must be a common understanding, and this we call operational excellence, and we give a variety of different tools to the teams, and whatever is appropriate, they can apply.

Biography

Barthold Piening is Executive Vice President of Operations for Nycomed.