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Biologics CMC Series (5): ICH Q12 Lifecycle Management—Using Established Conditions and PACMPs to Manage Post-Approval Changes
Biologics processes continue to evolve after approval. This guide explains how ICH Q12 uses Established Conditions, PACMPs, PLCM documents, and the PQS to make post-approval CMC changes more predictable and risk-based.
Jason Lu
Sep 616 min read
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