Pharmaceutical counterfeiting is putting millions of lives at risk each year, and governments around the world are taking action to address this growing problem. For many, the principal weapon in that fight is track and trace regulations centered on product serialization – assigning and affixing a unique number to products and tracking them throughout the supply chain. Compliance with these regulations will require companies to invest in new technology, make major process changes, and potentially restructure their supply chains. To ensure that such long-term, complex projects move forward as serialization requirements are being phased in over the next 10 years or so, pharma companies and their supply chain partners must begin making changes now. Serialization regulations will push change all along the supply chain. Manufacturers will have to change the way they package, mark, and label their products, including redesigning packaging to accommodate new barcodes, serial numbers, and anti-tampering features.
EU and US regulators are ushering in a new era of pharmaceutical manufacturing and distribution compliance. It’s expected to shake up safety and shift out counterfeit drugs from the supply chain. Regulators want to enforce the use of advanced traceability technologies to tighten up and standardize the distribution of pharmaceutical medicines so that the authenticity, identity and whereabouts of a particular drug product can be determined. According to the consulting firm Accenture, some two-dozen countries have implemented serialization regulations or are in the process of doing so. They encompass a diverse range of nations, from economically developed markets like Canada, Germany, South Korea, and the United States to less-developed countries such as India, Nigeria, Saudi Arabia, and Turkey.
Pharmaceutical track and trace systems provide the traceability of medicines across the supply chain, preventing reimbursement fraud and facilitating recall processes, another advantage is the availability of the obtained data store when evaluating health technologies. Many countries are looking for ways to adopt a medicine tracking system into their existing medicine delivery systems at a certain level. Traceability within the pharmaceutical supply means the ability to trace back a product right through the supply chain and being able to see when, and how a specific product was made and distributed through the supply chain. The new method being proposed is a so-called ‘track and trace’ system, using 2D barcodes on unit and shipper level and RFID on pallet level. The key reasons for deploying track & trace solutions are to enhance supply chain visibility, ensure compliance and reduce the frequency of theft and counterfeit products.
It may prove difficult for pharmaceutical manufacturers to comply with serialization regulations given the aggressive timetables in many countries. That’s likely to lead to supply chain bottlenecks, at least initially. Establishing collaborations with expert supply chain partners to find efficiencies and develop compliance capabilities now will be key to minimizing the time to deploy and ongoing costs as regulations roll out in the future
Traceability Solutions can supply both hardware and software solutions once we have analysed and understood the customer’s needs, thereby implementing the best level of serialisation needed. Our solutions can track and trace products from when they are marked or coded and verified through the supply and distribution chain up to the retail store and include marking, coding, scanning and a security solution for brand protection which offers full supply chain visibility. Our systems are suited for the pharmaceutical industry as they are robust, reliable, tried and tested and in addition, we offer a full turnkey solution – not just part of it!
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