Are your supply chain weaknesses putting patients at risk of not receiving safe, reliable medicines? This could be a difficult self-reflection for weak supply chains, devastated by the pandemic. The “race to the bottom” for cost and the cumulative effect of “lean-out” global supply chains have had an unintended consequence for the safe, reliable supply of product.  Many companies focus on their “site” compliance programs rather than risk across the supply chain. Third-party management has become a recognized risk, but what about fourth- and fifth-party management? Obviously, they’re all critical parts of the supply chain in a complex global economy.

While the industry has strained to keep its supply chain functional over the past several years, the major regulatory agencies were implementing very pointed and innovative strategies to understand the root causes of drug shortages. They were investing not only in solutions but their own capabilities. For these reasons, the industry should now respond and leverage the roadmaps that have been put in place. The regulatory thinking is in place, the documents and guidances are in flight, and industry leaders now need to integrate these into their multi-year strategies.

A sampling of documents that have been either published or drafted for public comment are listed below:

• “Risk Management Plans to Mitigate the Potential for Drug Shortages: Guidance for Industry” (May 2022) (here)
• ICH Q9(R1), Quality Risk Management (endorsed January 2023) (here)
• FDA Report “Drug Shortages: Root Causes and Potential Solutions” (updated 2020) (here)
• EMA “European Medicines Agencies Network Strategy to 2025: Protecting Health at a Time of Rapid Change” (updated 2020) (here)

Additionally, the FDA’s ability to assess risk in certain products’ supply chains was signed into law via the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (here). The time has come to accept that risk management as applied to a product’s supply chain is no longer just “nice to have.”

The FDA has brilliantly written that not only is “compliance” not enough, but incentives are needed to promote “Pharmaceutical Quality System Excellence.” This was previously described in Lachman blog posts (here and here). This journey shows no sign of stopping, and action should be taken during this time of setting objectives and developing multi-year plans with logical application of Quality Risk Management (QRM). Lachman has helped to integrate these activities into Data Governance programs so as to not create separate, disjointed initiatives. A key advantage of leveraging data governance is the systematic application of technologies, such as artificial intelligence, to secure data, simplify monitoring, and provide early detection of potential supply-chain shortages.

The door is open. Are you ready to enter?

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Patrick Day, M.S. is a Principal Consultant in the Compliance Practice at Lachman Consultants and an established pharmaceutical executive and practitioner with proven leadership in proactive risk identification, deployment of strategies to enhance compliance controls, and implementation of detection systems to eliminate blind spots. He is skilled in policy deployment as well as in leading the rollout of computer validation for vaccines, aseptic antibiotic, and cytotoxic operations. Mr. Day is well versed in FDA and MHRA regulations. He has trained FDA field inspectors for facility inspection techniques and has delivered talks on deployment of risk strategies and modern signal detection. His expertise includes in-house execution as well as outsourcing and governance of FM and laboratory services across US/UK and Asia-Pacific.