With serialisation deadlines on the horizon, Reinhold van Ackeren, Mettler-Toledo PCE outlines how contract packagers can best prepare.
Track and Trace
Q: How important is it for contract packaging companies to take notice of the international standards for pharmaceutical track and trace?
A: Contract packaging companies should take positive action with regard to serialisation and track and trace compliance. Not to do so could lead to contract and revenue losses. Far reaching requirements for the marking and verification of products are coming into law to protect goods against piracy and counterfeiting. Contract packaging companies are far from exempt when it comes to compliance. Manufacturers across a variety of industries are realising the benefits of successful tracking and tracing of products from a quality assurance perspective.
Q: What are the regulations specifically?
A: The main regulations are The European Union’s Falsified Medicines Directive (FMD) EU-2011/62 and the US Drug Quality and Security Act (DQSA). Both outline requirements for direct product marking and immediate verification of printed data, as well as the ability to store and submit that data to a central database in order to verify that products are genuine. Other global markets issuing similar regulatory requirements include China, Korea, and Saudi Arabia.
Q: What are the deadlines?
A: For the FMD, the deadline for compliance is 9 February 2019, whereas the DQSA will come into effect in November of 2017. Manufacturers will be required to label products with a unique serial number in both human and machine readable formats. 2D DataMatrix barcodes will include a serial number, expiration date and lot number – and at least in Europe anti-tampering devices will also be required to verify whether the packaging has been interfered with before reaching the end user.
Q: How can contract packagers prepare for serialisation?
A: Contract packagers wanting to continue working within the pharmaceutical industry ideally would have started to work towards compliance already. For those that have not started the process, it is important they work closely with customers to ensure the correct processes can be implemented. Serialisation is the basic requirement but it is important to know whether aggregation is also required. We know that many clients ask their suppliers also to secure product aggregation – even though this isn't required by law they see the advantages for their supply chain management. Once the requirements have been established, it is then advisable to find a partner who has proven systems and good experience of implementing serialisation solutions.
Q: Contract packagers often work in multiple industries. Is there a solution that enables them to run serialisation on single lines?
A: Software, such as PCE Line Manager (PLM) Direct, is now available that provides a perfect introduction to serialisation for contract packagers and manufacturers that do not require aggregation and who do not use multiple production lines in parallel. It has been created to network individual stations easily and directly with manufacturers’ IT systems for serialisation purposes. The software supports all of our serialisation stations, with or without tamper-evident modules and checkweighers. OEM kits also allow the software to be used when extending existing production lines. All systems print folding boxes with text or 2D codes and verify every label with an integrated smart camera. The software connects the systems to customers’ existing MES, ERP and cloud solutions.
Q: How do you work with customers to provide serialisation solutions?
A: We work with the producers to determine which coding scenarios are relevant for them. Experts from Mettler-Toledo visit the production facility to set up and commission the station. This service is included in the software package as standard, giving manufacturers a ready-to-use serialisation solution.
Q: Is the software scalable? What happens if a contract packager expands its pharmaceutical business?
A: The software package is extremely flexible and scalable. Should requirements change, companies can upgrade the software. Companies can tailor the software package to fit in with their own unique requirements.
Q: In your opinion, when should contract packaging companies be looking into serialisation solutions?
A: If they are looking to do business in the pharmaceutical sector – or to continue to do so – then it is paramount to look into serialisation at the earliest possible time. Being prepared ahead of deadline will enable contract packagers to avoid relabelling or repackaging old stock in 2017, 2019 and beyond. We have been developing serialisation systems for international customers for years. Tried-and-tested hardware and software solutions are already available – and have evolved to be particularly easy to use.
Q: Do you have any advice for contract packagers looking to implement serialisation?
A: It is important to understand customer requirements and work with an expert provider who will make the effort to entirely understand your requirements.