Global Cold Chain Connections

A Process Validation Guide for Cold Chain Logistics

Gary Hutchinson
Contributor: Gary Hutchinson
Posted: 09/15/2015

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:•

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Gary Hutchinson
Contributor: Gary Hutchinson
Posted: 09/15/2015

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