Managing and tracking products as they move through the supply chain is critical to ensuring consumer safety and protecting product branding. Contract manufacturers have taken a larger role in pharmaceutical manufacturing as globalisation allows pharmaceutical companies to sell into more territories than they have in the past.
This does mean, however, that there is also an increase in smaller companies with less expertise — or from less tightly controlled markets — becoming suppliers of raw materials for pharmaceutical manufacture.
Unfortunately, these companies may not offer the same quality assurance that pharma manufacturers are used to seeing, as they often operate according to a different set of standards than the pharmaceutical industry. Sometimes suppliers will have formulations ready to sell … but the quality and grade of the formulation will not appropriate for pharmaceutical manufacturers.
Learning to address these challenges is critical when setting up your supply chain. Here are four ways to ensure your suppliers meet requirements — some of which you probably already do:
- Ensure the complete audit capabilities of the supplier and that any raw goods they source come from reputable suppliers themselves. This can be tricky to do individually, so partnering with a local consultant or supply chain manager in the region/country can provide assurance that they are able to monitor local suppliers effectively.
- Track every product using advanced in-house transport and logistics management. All raw materials need to be stored in the appropriate conditions (temperature, humidity, etc.), which you should monitor in your warehouse. To make tracking the source of any potential issues that may arise easier, avoid mixing batches of raw material together that are sourced from different suppliers.
- Check product formulation using in-house lab testing. This allows you to verify the quality of the products received and work with the supplier to either improve the quality or drop them and go with a supplier who can meet your standards.
- Follow all serialisation and aggregation requirements for the countries you serve. We recommend adding aggregation to all your packaging lines if you haven’t already; it provides a useful overview of your distribution network and will likely be required soon enough. Standardising the process across all your packaging lines helps to cut down on training issues for operators.
Andreas Bechthold, General Manager, Mettler-Toledo
Andreas Bechthold, General Manager for Mettler-Toledo PCE, explains how companies can better manage their supply chain to avoid potential issues: “With an ever-expanding supply chain, companies would do well to monitor the sources of their raw products, either directly or with a partner organisation."
"Systems to manage the complexity of these supply chains is important, especially as companies seek goods and raw materials from a global market. Having checks and balances within your production line serves as a second line of defence, ensuring that formulations are correct. Additionally, it’s necessary to comply with local and global serialisation requirements to protect your brand and, ultimately, keep consumers safe.”
Just as California and Turkey helped to propel serialisation into standard regulations in the US and EU, the traceability of raw materials may become a hot topic for regulators. Staying ahead of regulations may help your business to succeed … and offer you the opportunity to grow a healthy supply chain poised for the future.
Track and trace specialists such as Mettler-Toledo can help you to manage a robust supply chain throughout the pharmaceutical production process. From transport logistics, engineering, chemical production, formulation and serialisation of the end package, solutions are available to help track your complete pharmaceutical manufacturing needs.