On November 27, 2013, the Public Law 113-54, referred to also as Drug Supply Chain Security Act (DSCSA) was made law. This document established new federal requirements for traceability and ensures consistency throughout the US drug supply chain, with penalties for breach of legislation. Currently the DSCSA requires pharmaceutical companies to share the transactional history of prescription drugs at batch level; however in 2017 this will extend to serialization information at the packaging level. In 2023 manufacturers will have to share full traceability information about the entire supply chain – evoking the need for advanced data collection and full connectivity to prove accurate transparency.
Time to get connected
Given this move towards improved data management, what pharmaceutical manufacturers require is better connectivity solutions in place with their product inspection systems, enabling them to efficiently collect and analyse information from their production lines. Automated consolidation of data from multiple product inspection systems into a central location began in the US in recent years and has spread worldwide. Prior to that, data at pharmaceutical manufacturing facilities had to be collected manually, with personnel walking from one machine to another and physically gathering data using paper based systems. The potential for error was therefore significant.
Today, a broad range of sophisticated connectivity solutions are available enabling product inspection systems, such as metal detectors, checkweighers, x-ray and vision inspection technologies, to be integrated as part of a data collection solution. These new data management solutions are designed to facilitate the connection of multiple inspection systems into a centralised data collection hub. This allows information about a range of product inspection issues to be stored and accessed from a single remote location, significantly reducing the level of interaction required by line operatives with machinery on the factory floor, and decreasing the risk of human error.
Such technologies remotely collect data such as pack counts, rejected pack counts, lot or batch numbers, production dates, seal integrity information, and audit trails for machine adjustments. This enables manufacturers to monitor their lines for product quality issues, such as foreign body contamination, product over- or under-fill, or even packaging and labelling anomalies. Not only can this enable them to demonstrate due diligence to authorities, in the event of a product recall, it can also allow them to proactively highlight any issues in advance before they become a problem allowing planned action to be taken, thereby minimising the risk of defected product reaching the consumer.
Innovative data collection solutions can go much further than this however. Technologies, such as Mettler-Toledo’s ProdX software, are able to record and display not just product quality information from one type of system but all product inspection systems in a consistent manner. This type of software is capable of executing an array of additional functions such as monitoring and documenting machine performance. Linked to the manufacturer’s Enterprise Resource Planning (ERP) systems, these software solutions can allow data to be accessed, analysed and acted upon in real-time, enabling the identification of errors and problems before sub-standard products leave the factory.
An edge in efficiency
It is clear therefore that this ability to automatically and remotely collect data from multiple connected inspection systems does not just give the pharmaceutical manufacturer a greater degree of traceability: it can also have a profound impact on manufacturing efficiency and on the quality of pharmaceutical product being produced. Looking to the future, this technology may further enable manufacturers to efficiently manage traceability of their products through the data provided.
Connecting systems and collecting and storing data in this way minimises the risk of human error that was inherent in manual data input and analysis. Should there be a need for a product recall, product inspection data can be quickly accessed and examined, facilitating a much faster response when there may be a need for public reassurance.
There are numerous examples that illustrate how connecting data from specific types of machines can improve a manufacturer’s efficiency and performance. For example, connectivity technology, such as ProdX, can already allow manufacturers to adjust the settings of all of their product inspection equipment remotely during a product changeover, helping to minimise downtime and optimise line productivity. Equipment settings can be stored for future use, further reducing set-up times.
Connectivity can achieve more than this though: it can optimise production line efficiency. A multinational company that produces pharmaceutical goods and utilises a metal detector, will save time and resources because the machines will transfer data from geographically remote facilities to a local computer which automatically inputs new information into an accounting package. Connectivity between production line checkweighers can enable feedback of information about fill levels to the filling machine to alter portion sizes when necessary, thereby reducing costly product giveaways and product under- or over-fill in the future.
As powerful as these solutions have become, we can still do more. In the pharmaceutical industry, vision inspection technology is used to track and trace serial numbers using strategically placed print devices and cameras on the production line and within product inspection systems.
A connected future
With regulations governing pharmaceutical traceability growing ever stricter all the time, pharmaceutical manufacturers must continue to be vigilant in maintaining the highest possible production standards and ensure the integrity of their products. The connectivity that data management technology can give them today can enable pharamaceutical manufacturers to trace their products through the supply chain, as well as monitor line performance.
Connectivity solutions are evolving all the time, however, enabling pharmaceutical manufacturers to collect even more information and perform ever more operations remotely at the touch of a button. By embracing the most cutting-edge, they can go a long way towards not just safeguarding product quality, but also optimising the performance and efficiency of their production lines. In doing so, they can uphold the consumer welfare and stay ahead of pharmaceutical safety legislation, while also reducing operating costs, ultimately protecting their bottom line and their business.
(The Author is Marketing Communications Manager for the Product Inspection Division of Mettler-Toledo, based in the UK)