A Process Validation Guide for Cold Chain Logistics
Process validation for cold chain logistics (packaging, storage, and distribution) is a required part of the Common Technical Document (CTD) for any Biologics License Application (BLA) for monoclonal antibodies. Any review of the submitted dossier and subsequent pre-approval inspection onsite will most likely review the following areas:
• Stability testing
• Thermal packaging qualification
• Process validation
• Validation master planning
Strategies focused only on the packaging qualification and do not consider validating the process of drug product transport and the potential impact on the potency, efficacy, or purity of the drug product, as compared to the specification, will be challenged by regulatory agencies around the world. The best practices identified and current expectation from regulatory agencies globally is drug product quality will be confirmed after transport.