FDA Finalizes Guidance on Pharmaceutical Lifecycle Management

Pharmaceutical Technology Editors

The guidance provides a framework for the management of postapproval chemistry, manufacturing, and controls changes.

FDA announced on May 11, 2021 that it has made the final version of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management available. The guidance provides a framework for managing postapproval chemistry, manufacturing, and controls (CMC) changes and discusses necessary elements for assuring product quality in a regulatory submission changed postapproval. The guidance also promotes manufacturing innovations through a risk-based approach to regulatory oversight and continued product improvement, which may mitigate manufacturing and quality issues. The guidance document’s Annexes provide examples of how tools described in ICH Q12 could be applied.

Source: FDA