June 11, 2021

The management of post-approval changes has always been challenging for pharmaceutical companies with respect to time, cost and resources. The International Council for Harmonisation (ICH) Q12 guideline establishes a framework for managing post-approval changes more productively and efficiently, thereby helping patients, industry and regulators.

ICH Q12 specifically addresses the commercial phase of the product lifecycle. Along with ICH Q8 – Q11, these guidelines provide a globally harmonized framework that increases science- and risk-based approaches for accessing changes and allows greater flexibility in managing post-approval changes.

More broadly, the application and use of ICH Q12 tools promote manufacturing innovation and continual improvement and allows regulatory authorities to better understand companies’ pharmaceutical quality systems (PQS) for management of post-approval CMC changes. The application and use of ICH Q12 tools enable risk-based categorization of changes, advanced determination of reporting categories and the data required for filing purposes.

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