In our last blog, we discussed the need for transparency and visibility throughout the labeling process. Reducing the risk of product recalls and non-compliance being the goal. Most would agree that given a clear mandate plus an appropriate level of investment, this can be achieved. Not always easy, but certainly possible. Introducing the required cultural and organisational changes can be a different subject altogether! But what if part of your labeling processes are outsourced either because you’d prefer not to have the overhead or, like much of the life sciences industry, your supply chain spans many CMOs (Contract Manufacturing Organisations)? Now let’s add some new legislation into the mix just for fun.
If you’re a pharma manufacturer, meeting the DSCSA (Drug Supply Chain Security Act) and FMD (Falsified Medicines Directive) requirements for product and package level serialisation is probably going to be at the forefront of your mind right now. If your business is medical devices, then it’s likely to be maintaining integrity of UDIs throughout the supply chain and the task of getting your labeling content ‘fit for purpose’ ahead of upload to either the GUDID or EUDAMED (or possibly both) that will be grabbing mindshare. Before we go any further, let’s look at current supply chain trends across the life sciences industry. According to a survey carried out by NICE Insight in 2016, 69% of pharma and biotech companies expected to increase their use of CMOs going forward – business drivers being to increase agility whilst reducing costs. Gaining rapid entry into emerging markets, portfolio transformation and new partnerships and alliances are contributing factors to this increasing trend. The flip side of this being the risk of non-compliance from introducing multiple potential points of failure.
So how do you maintain the integrity and accuracy of your labeling content when your global supply chain may include tens, if not hundreds of affiliates sitting between you and your end customer? How do you also validate that what your partners print on the label aligns with content submitted as part of the regulatory approvals process, including that which is required to satisfy local HA’s?
This is where adopting a cloud based labeling and artwork management solution helps to remove the barriers and disconnects that can often occur across highly fragmented supply chains. Implementation can be quick and easy and new partners can be onboarded with minimal integration effort. Suddenly, the headaches of trying to exchange and align both static and variable labeling content across 3rd party systems and processes is removed as everyone and everything is connected. Content is all held in one place – safely and securely. Every partner can become a user of the solution and with appropriate permissions, users can review, edit or approve content. Better than this, corporate oversight becomes a given ensuring management by truth and not perception.
How about the challenge of ensuring alignment of serialisation and UDI content across highly distributed supply chains? How do you also ensure integrity of variable data at print run time with the inevitable disruptions caused by manufacturing downtime and labels that need to be re-printed for quality purposes? Well, here again having ‘variable’ (i.e. print run time) as well as ‘static’ content captured in one single place makes it easy to recover from such situations without risking duplication or inconsistencies.