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 planningStrategies focused only on the packaging qualification and do...
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