Supply Security in Pharma Excipients – Ensure production continuity and regulatory compliance by reducing the risk of disruption in the supply chain of critical excipients

Challenge

• Dependence on a small number of suppliers and global shocks (pandemics, logistics, geopolitical tensions, climate changes) increase the risk of disruption in the supply chain of critical excipients.
• Excipients affect the quality, stability, and safety of the finished product and any change could critically affect the product quality attributes. Regulatory authorities (FDA, EMA) require shortage mitigation plans and strict controls for supplier changes.

Solution

• Elaborate dual-sourcing plans through the qualification of at least two independent suppliers for each critical excipient.
• Perform analytical verifications, comparability studies, and process impact assessments.
• Integrate Risk Management, Procurement, Quality, and Change Control.
• Maintain strategic inventories and comparability dossiers to accelerate technical and regulatory substitutions.

Proof

• Activating a dual-sourcing plan speeding up the qualification of alternate suppliers through due diligence, site audits inspections and analytical comparability are practical skills supporting the dual source strategy.
• Recent shortages (PEG 80, microcrystalline cellulose, sodium starch glycolate) have caused significant production disruptions for solid dosage forms and injectables (vaccines, biologics), confirming the real impact and the need for countermeasures.

Take-away message

• Procurement and Quality must operate as an integrated function.
• Dual sourcing, strategic inventories and comparability dossiers are essential measures to ensure production continuity, regulatory compliance and reduced operational exposure mitigating supply chain disruption.

Resources

Contact Pharmatrans SANAQ AG [email protected]  for further information.