Serialisation and the wider system landscape

3C Integrity have been busy recently speaking at various events and conferences include The TrackTS and FlyPharma conferences. Ian spoke and attended both of these events. During his time at both events he delivered expert serialisation advice and uncovered the current state of serialisation readiness in the pharma sector. We’ve put together a short series of blog posts on our experience at the events.

Ian recently spoke at, and attended, The TrackTS conference, this conference is the latest in a long series of conferences and seminars aimed at the issue of serialisation. Whilst to a great extent familiar ground was covered with presenters delivering case studies from both big and small pharma, solution providers describing the virtues of their particular approaches and others describing the twists and turns of the regulatory landscape, I felt that there were some new themes beginning to emerge.

The wider system landscape

The first of these was the recognition that – as we have termed it – “the wider system landscape” is critical. A pharma company’s ability to meet the current and emerging regulations is critically dependent upon the capabilities in the wider supply chain. This includes any CMOs in play, and any supply and distribution partners handling the product on behalf of the MAH prior to the point of change in title. Implementations to date have focussed to a great extent on the in-house manufacturing capability and only now are companies beginning to turn their attention to their supply chain partners.

A case in point was the excellent presentation by a tier one pharma. The presenter reported that:

• • 27 internal manufacturing lines had been made ready for serialisation
• • 40 further internal manufacturing lines were still to be made ready (a challenge in itself)
• • No CMOs in the supply chain had been connected
• • 1 ‘serialisation savvy’ CMO is on a pilot project but 10 months in they are still not connected.

Based on these figures the presenter went on to say that:

• • 15 organisations need to be connected per year to be ready for the EU-FMD requirements
• • 10 CMOs per year is the limit to the integration process, they found it unscalable beyond that
• • 500 internal man days are being devoted to the project

The company in question had surveyed their CMOs and categorised them red, amber, or green according to the likelihood that they will be ready and integrated on time:

• • 30% of their current CMOs are in the red category
• • 16% in amber
• • almost 50% of their CMOs are considered to be at real risk of not being ready on time, putting the effected products at risk.

Strategies being considered to mitigate this risk were to abandon the products in question – perhaps low margin/low volume products that could not justify the investment of the alternative strategies of bringing the manufacture back in house, or tech transferring to safer pairs of hands.

The message arising from this for manufacturers if clear – look to your wider system landscape sooner rather than later, assess the risk and be ready to take some tough decisions in order to secure your supply.

Get ready for serialisation to stay in the supply chain

The message for CMOs is also clear – in order to stay in the game you must achieve a state of readiness for serialisation and simplify your connection to your clients serialisation systems or you risk being cut out of the supply chain all together.

The second theme was that people are beginning to discuss the outlook for the later adopters – these are companies who for whatever reason choose to ignore the evidence presented in the many case studies about the scale and complexity of serialisation implementation, and are still “on-hold” waiting to start their own programmes. Whilst many may be banking on the requirements being postponed in the face of a poor state of readiness in the industry, commentators close to the EU seem adamant that this will not be the case.

Whilst a lot of the discussion was around finding ways of engaging the senior stakeholders in order to simply get the programmes underway, it is clear that the programmes of the late adopters will have to find ways to accelerate their progress, perhaps as Thomas Brückner (Vice Chairman and member of the Executive Board- securPharm e.V. and Head of Pharmaceutical Affairs, GMN, Medical Devices – German Pharmaceutical Industry Association (BPI) e.V.) suggested they will have to do “strange and new things – and break some rules” in order to be ready on time.

3C Integrity can help

At 3C Integrity we regularly run innovative, vendor-independent training events that offer a unique and invaluable chance to ensure your programme is on the right course. Our next one-day serialisation training event is taking place on the 12th November in Milan, we also provide in-house training events and consultancy for clients across the world contact events@excellishealth.eu for more information.

Download this short series of blog posts as a free white paper resource from our website. We have a wide range of additional pharma serialisation advice to download from serial number management to 10 things pharma manufacturers need to consider to be ready for the EU-FMD.