Posted 16 May 2017
By Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Vijayalakshmi Iyer
This article discusses the latest draft of ICH Q12 and significance of harmonizing regulatory requirements across regional borders. It emphasizes how Post-Approval Change Management Protocol (PACMP) can be used as a tool to improve strategic change management and ensure supply chain reliability.
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Categories: Biologics and biotechnology, Drugs, Quality, Features, US, Europe, FDA, ICH
Tags: ICH Q12, Post Approval Change Management Protocol, Quality by Design, QbD