history, reviewing several years of past data (often up to five years) to ensure alignment with expected standards. It is important to select a manufacturing partner who can support the regulatory and quality requirements of your entire lifecycle. Your QMS should include pre-qualification performance checks and shipment checklists that reconcile CoAs to end-use requirements, tightening sampling or testing for infrequent or campaign-based production. When qualifying a second API source, it’s critical to do so well before a supply chain disruption occurs. FDA approval of prior approval supplements for changes to a manufacturing process have lengthened and it’s not uncommon to see this take 1114 months. The importance of on-site inspections Regulators have largely returned to stringent inperson audits to verify that site conditions match paper records and reported practices. The EMA has indicated that remote assessments should not replace on-site inspections except in crises and are not advised for consecutive inspections4. On-site frequency should be risk-based. New or higher-risk API sources, particularly from offshore sites or for complex chemistries, generally warrant an initial on-site audit, with scope and cadence set by your internal policy and the supplier’s risk profile. Requalify and reassess suppliers regularly: Reassessment cadence is best set by risk tier, usage and quality history. For many portfolios, that translates to a roughly two-to-four year on-site cycle, with intervening desktop reviews and performance monitoring. Where you cannot revisit a site on schedule, credible third-party or regulator audits can help maintain oversight provided your QMS reviews the reports and tracks any follow-ups. Digital supply chain monitoring with AI and predictive analytics As deliveries have become less reliable, companies have adopted more sophisticated inventory and safety-stock planning, typically building 12-18-month rolling forecasts and reviewing recent supply interruptions, including raw-material constraints. Large pharma companies are investing in digital supply chain monitoring and AI for inventory management, planning safety stocks and logistics. Using sales trends, external indicators and historical variability, predictive models help prevent shortages months in advance and minimise unnecessary costs. Adoption is broadening as the business case strengthens, though effectiveness depends on data quality, crossfunctional use and governance (i.e. who acts on the alerts). Ensuring API resilience As we navigate an uncertain environment, ensuring security in API supply involves more than implementing a series of practical steps; it requires a strategic business shift from focusing on short-term cost efficiency to emphasising risk mitigation and long-term planning. Resilient API supply chains depend on companies anticipating potential points of failure, maintaining safety stocks and adequately qualifying suppliers to maintain consistent quality and ensure supply continuity in the future. Supply chain resilience must be treated as a design choice, not an emergency response. References 1. U.S. International Trade Commission. Harmonized Tariff Schedule of the United States Revision 2 (2026), Chapter 30, Pharmaceutical products. Accessed February 3, 2026. https://hts.usitc.gov/ reststop/file?release=currentRelease&filename =Chapter%2030 2. U.S. International Trade Commission. Harmonized Tariff Schedule of the United States Revision 2 (2026), Chapter 29, Organic chemicals. Accessed February 3, 2026. https://hts.usitc.gov/reststop/ file?release=currentRelease&filename= Chapter%2029 3. European Commission. EU-US trade deal explained. July 29, 2025. Accessed January 13, 2026. https://ec.europa.eu/commission/ presscorner/api/files/document/print/en/ qanda_25_1930/QANDA_25_1930_EN.pdf 4. European Medicines Agency. Guidance related to GMP/GDP and PMF distant assessments. June 13, 2024. Accessed January 8, 2026. https:// www.ema.europa.eu/en/documents/scientificguideline/guidance-related-gmp-gdp-pmfdistant-assessments_en.pdf 38 SELWYN LUSTMAN Senior Vice-President of Sourcing & Procurement LGM Pharma LGM PHARMA TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2026
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