One Plus One is Greater Than Two for Migrating Pharmaceutical Processes

Migrating Pharmaceutical Processes

Some decisions are incredibly easy to make, like which restaurant to go to, or which movie to watch. Others, which attract greater – for want of a better word – risk, can take a little longer, such as which car to buy.

If you scale this up to a new house purchase the risks become commensurately larger.

Now imagine this decision is based on you making the best possible use of your company’s money for a new asset purchase or a revised operational approach. Here the challenge requires an incredible amount of investigation and due diligence.

In all of the personal instances, there is one common factor – peace of mind. A restaurant or movie may have five stars, a car might be Car of the Year and the new house is in a popular up-and-coming area.

The question is, how do you attach this type of perception and, of course, peace of mind, to an industrial environment?

A couple of years ago, my company Alfasigma made a decision to evolve its operations, to give us the capabilities to address upcoming legislation and more stringent pharmaceutical industry demands. The questions were, where do we start and who do we get to help us? This is where peace of mind and capabilities come into play.

We knew we needed a package that covered every facet of our operations – from HVAC, through batch control and onto serialisation across our supply chain – and delivered the data we needed for dissemination both internally and externally.

This all-in-one technical solution is something in demand all across the industry but, surprisingly, is not offered by too many companies.

To compound the complexity of the decision-making process we also identified the need for a supplier that already had a significant pedigree in this market and understood international demands.

And, just to make them work really hard, we needed a modular and scalable solution – we weren’t going to jump in with both feet, we wanted to see a pilot project that could be scaled up and migrated across our existing infrastructure. We needed an organisation that would hold our hand and lead us towards an optimum solution.

Each stage of this planning process saw more and more suppliers falling by the wayside as we culled the list of potential suitors down to a select few.

I am pleased to say that we eventually opted for one that said the right things, had the right solutions, knew precisely what we wanted and knew the pharmaceutical industry inside out. More importantly, they give us the all-important peace of mind.

So, where are we now? This process started two years ago and we have made huge strides. From the very first step of knowing the best time to start the evolution, we have since developed a pilot project based in a new development at one of our plants, which is running in parallel with an existing line, so we can compare results.

In terms of deliverables we are expecting efficiency gains, far greater data integrity, more stringent adherence to industry and legislative requirements, better process control and, of course, better quality levels.

We can now show our customers and the industry in general that we are in line with GMP guidelines and that we can offer traceability and serialisation for all production parameters.

There aren’t many suppliers that could offer what we needed, even fewer had the necessary industry experience and only one gave us the peace of mind we were looking for all along. This is a complicated process and, sure, it has its risks, but find the right supplier and life becomes immeasurably easier.

Eugenio Starita
Posted May 11, 2018 By Eugenio Starita, Alanno Plant Director, Corporate Pharma CMO & Technical Development , Alfasigma S.p.A.
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