Thorough supply chain management and end-to-end quality assurance are of utmost value to pharma compliance and patient safety. A significant part of maintaining quality involves ensuring standards are upheld along the global supply chain, regarding active pharmaceutical ingredients (APIs) and beyond.
This vigilance is something the global food industry has been diligent in cultivating and, thanks to contamination issues and other incidents, professionals in that industry have learned the hard way. Most major food retailers have digitalized their supply chain quality management and monitoring, in order to minimize the risk of standards slipping.
However, most pharmaceutical companies have not undergone such an update in their organizations. The vast majority handle vetting, logging, updating, and reporting through a combination of spreadsheets and emails, an outdated approach that is time-consuming, costly, and prone to risk.
Outsourcing-Pharma connected with Gaëlle Jaron, co-founder of Rephine Catena, to learn more about possible lessons the pharma industry can learn by diving into the digital transformation of the food industry supply chain.
OSP: Please share the ‘elevator presentation’ description of Rephine—who you are, key capabilities, industries served, and what sets you apart from similar companies.
GJ: Rephine is a firm of deeply experienced GMP auditors that proactively help pharmaceutical companies around the world with their supply-chain quality assurance. I lead the digital services business of Rephine, including Rephine Catena, its new end-to-end digital solution for global supplier quality management.
OSP: Could you please share some of the key challenges and problems you believe the global pharma supply chain faces?
GJ: The recent pandemic has forced the weaknesses of current supply chains into the spotlight. Combined with resumed M&A activity (particularly painful for CMOs), it is almost impossible for teams to manage and ensure all aspects of supplier quality are perfectly under control.
OSP: What is the limiting factor?
GJ: Today, the vast majority of drug manufacturers perform global supplier vetting, logging, updating, and reporting manually, using spreadsheets. This outdated approach is fraught with risk, while its labor intensity can result in annual costs approaching €100,000 for smaller companies and over half a million for larger entities, to monitor and manage all suppliers.
Given the criticality of end-to-end quality assurance to pharma compliance, marketing authorization, and patient safety, it is puzzling that entire industry supply chains are not subjected to more rigorous, systemized scrutiny.
OSP: How have pharma industry professionals worked to try and change some of these issues for the better?
GJ: To date, the vast majority have continued with manual processes: they have not sought to transform their vetting digitally. This is surprising given that so much is invested in products and in sales, yet without quality assurance and compliance right along the supply chain, products cannot be authorized or sold – certainly not in highly regulated/developed markets.
OSP: You mention a lot of the vetting, logging, updating, and reporting pharma orgs do are manual and/or spreadsheet-based. Could you share some of the issues associated with that approach?
GJ: It is hugely labor-intensive and therefore costly, and it is highly risky too because there is potential for issues to slip through the net. This is partly due to the fragmented nature of current processes and ‘systems’, and also because of the reliance on audit cycles which give a snapshot of quality and compliance at a single point of time every two to three years.
Monitoring and reporting are not applied for all suppliers, nor is it done continuously, so there is a risk that if something changes or slips in between it won’t be picked up until much later. Ultimately, authorization and therefore revenue is at risk if compliance isn’t constant.
OSP: You also mention that the food industry might be a good example to follow regarding supply chain operation. Could you please share some of what that industry does right?
GJ: The food industry has taken action to mitigate risk, build trust and improve its reputation in the wake of publicly known safety issues. Rather than wait for regulation, leading food retailers have taken steps to increase their own visibility, knowledge, and control of quality along the supply chain.
OSP: How much of the food industry approach can be copied—what similarities in food and pharma exist to make duplicating that template possible, so to speak?
GJ: Although the regulatory environment and the products being manufactured are different, the premise is the same – the need to uphold and be able to vouch for the highest levels of quality, consistency, and public safety through fastidious, continuous, and consistent monitoring of the entire supply chain, end to end. There are many strong examples of progress in the food industry today that show pharma what’s possible.
OS: What does a successful digital supply chain management strategy look like?
GJ: It starts with complete knowledge of the supply chain, beyond direct suppliers. Accurate risk assessment increasingly requires a clear line of sight across lower-tier suppliers too. As well as consistent, continuous monitoring and flagging of any issues, standardized data capture, and unified forms of communication across locations create opportunities for pharma brands to share and encourage best practices; and to target support, to bring any “struggling” suppliers up to standard.
OSP: How would you recommend a pharma supply chain outdated system begin to change for the better?
GJ: As an industry coming to the digital supply chain quality monitoring and management process as a greenfield activity, pharma has the potential to move straight to best practice - learning from the experiences of sectors like the food industry.
Perhaps the most striking takeaway from all of these food industry transformations is the extent to which smarter supply chain quality management can be a competitive advantage.
Taking action needn’t be onerous, as long as the start and endpoints are clear. Establishing a multi-disciplinary task force will help. Ideally, this will include representatives from quality, procurement, and IT, a supply chain representative (if such a team exists), and someone from regulatory.
Simply buying an electronic quality management system (QMS) is not the answer: this will barely scratch the surface of the required capabilities suggested by the food industry scenarios. Transformation requires a detailed understanding of the corporate picture, globally. Also, any new capability must be able to connect to and exchange data and intelligence with existing systems, to avoid creating new silos and manual processes.
Demands for greater supply chain transparency and evidence-based quality claims are already strong; within two to three years such expectations will be greater still - and in many cases, mandatory. Therefore, delaying transformation is not an option.