SUPPLY CHAIN MANAGEMENT
patients, the likelihood of temperature excursions increases, while detectability plummets.
When drugs are in transit, visibility diminishes, making it essential for sponsors to have robust processes in place to ensure transit-based excursions are identified and reported. Visibility reduces further still for drugs stored at clinical sites, heightening risk and placing increased pressure on sponsors to effectively mitigate it.
To uphold the stability of these high value study drugs, a holistic, connected and technology-enabled temperature surveillance and management strategy is required: one that is fuelled by accurate and complete data, and bolstered by expertise, to deliver endto-end visibility and control without creating additional workload for any one stakeholder group.
The use of advanced functionality, including lifecycle tracking and automated adjudication can facilitate fast and informed decision making and minimise the likelihood of needing to reschedule patients and conduct costly resupply activity. Furthermore, prioritising complete and accurate data can support sponsors to manage deviations more proactively and effectively, while facilitating audit readiness.
Upholding compliance
Ensuring compliance requires a comprehensive and proactive approach. Rigorously adhering to GMP standards guarantees consistent quality, purity and stability, while following GDP guidelines maintains integrity throughout transport and storage.
As noted, robust cold-chain management is particularly critical for temperature-sensitive supplies, with end-to-end monitoring essential to both prevent and detect excursions and demonstrate compliance with complete, audit-ready data. Accurate labelling, serialisation and traceability support regulatory compliance and reduce the risk of errors and enhance patient safety.
Equally important are robust documentation and regulatory reporting practices. Maintaining complete records of manufacturing, packaging, storage and distribution activities demonstrates compliance and supports more efficient inspections.
Import and export considerations can add further complexity, particularly for IMPs classed as controlled or high-potency compounds, where customs, licensing and local regulatory requirements can vary significantly between regions.
With 52 % of supply chain delays caused by customs and regulatory clearance issues3, understanding the nuances at play is critical to designing compliant and optimised distribution operations. This includes Importer of Record responsibilities, lead times, documentation requirements, airport facilities, broker interactions, product valuation methodology and temperature-controlled shipping needs.
Qualified Person( QP) release is a crucial regulatory step for trials operating in the EU, ensuring each batch complies with GMP, approved specifications and clinical trial protocols. The small, potent and specialised nature of these batches can make QP certification a bottleneck, especially when accounting for blinding, randomisation, and multicountry labelling. Co-ordinating closely with manufacturers, CDMOs and QPs to align production, testing, and release schedules can help to safeguard compliance, trial integrity, and timely supply.
Safeguarding success, supplying with care
The complex nature of IMPs impacts every stage of the clinical trial supply chain. Forecasting necessitates careful
management and early planning to overcome inherently uncertain demand and avoid either waste or stock-out scenarios. For clinical supply packaging, progressive production strategies, including JTL and JTM, can support leaner, more patient-centric supply chains.
Managing end-to-end temperature for IMPs is another key consideration. A best practice approach demands a holistic, connected and technologyenabled surveillance and management strategy that serves to protect patient safety and supply integrity by reducing the likelihood of temperature excursions occurring, increasing the detectability of temperature excursions when they do occur and providing end-to-end visibility via centralised access to complete, audit-ready temperature data.
Equally, rigorous compliance management, including GMP and GDP, is essential for creating robust clinical supply chains, as is access to appropriate expertise and capability required to navigate global import / export complexity and QP release. By integrating these best practices, sponsors are better equipped to uphold patient safety, maintain regulatory compliance and strengthen the reliability of clinical trial data. ●
Gillian Wilson
PROJECT SERVICES LIAISON
References: 1: Pharmaceutical Chemicals Market Booms with Rising API Demand, Pharma Advancement. 2: H. M. Patel, M. R. Patel, S. J. Patel & M. R. Patel, Pharmaceuticals: Past and Present, J. Adv. Pharm. Technol. Res., 2011, 2( 3), 137 – 141. 3: Supply Chain in the Pharma Industry – Statistics, Gitnux.
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ALMAC CLINICAL SERVICES gillian. wilson @ almac. com www. almac. com
60 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981