ICH Q12 Post Approval Change Management Protocol: Advantages for Consumers, Regulators and Industry
By Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Vijayalakshmi Iyer -
Published 16 May 2017
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.
Categories: Features, Europe, US, FDA, ICH, Biologics and biotechnology, Drugs, Quality
Tags: ICH Q12, Post Approval Change Management Protocol, Quality by Design, QbD