is clear and we have identified four key elements to help meet this commitment: prevention, which includes ensuring regulatory compliance, robust quality management processes, operational excellence, supply chain security, infrastructure investments, and business continuity planning; technology, to enhance product quality and purity and the robustness of the manufacturing process; inventory management, to ensure we have the right quantities of the product housed in diverse locations; and diversification of manufacturing capacity and implementation of second-sourcing within Amgen’s network.
3. Contribute and collaborate with authorities
Working with regulatory bodies is central to approaching the drug shortages challenge successfully. The formation of the FDA’s Drug Shortages Task Force, to meet the requirements of the Safety and Innovation Act (FDASIA), is a great example of how pooling new ideas can encourage high quality, and facilitate the expansion of manufacturing capacity. Amgen has contributed to the Task Force by sharing its own best practices, including the way we measure and monitor production time and the importance of applying the same high standards of quality management systems to contract manufacturing partners.
We also believe that information about all companies’ manufacturing quality should be made available and shared with purchasers, prescribers and consumers, to make informed choices that will help ensure a continuous and reliable supply of quality medicines to patients. The FDA can also help by assisting with faster and more streamlined product and technology approvals, facilitating greater transparency of compliance status of manufacturing sites with the public, reducing certain regulatory oversights and extending the interval between routine GMP inspections.
4. Collaborate with industry to share key insights
The benefit of inter-industry collaboration can be observed from the successes of groups such as the not-for-profit Rx-360 consortium (of which I am an officer), which actively shares information on thedevelopment of processes related to the integrity of the healthcare supply chain and the quality of materials within it.
The value of collaboration is perhaps most evident when issues arise – such as when Amgen identified lamellae (thin particles of delaminated glass) in non-distributed batches of one of our products. Through a robust investigation into these lamellae we were able to narrow down the causes, develop better techniques for characterizing (glass) quality, and enhance our evaluation of glass manufacturers. We shared these learnings with regulators and other companies to improve the quality of glass used to store products across the industry.
It is imperative for drug makers to solve the drug shortage problem – patients are counting on us. To make a tangible difference, all companies must make the necessary investments in quality manufacturing and work together to better serve patients right from the start.
