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# Drug Guide on Q12 Technical and Regulatory Considerations
- URL: https://www.fdaweb.com/drug-guide-on-q12-technical-and-regulatory-considerations/
- Published: 2021-05-12T12:00:00.000Z
- Updated: 2026-09-14T16:58:30.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149309

*Federal Register* notice: FDA has made available a final guidance entitled *Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management*. The document provides a framework to facilitate the management of post-approval chemistry, manufacturing, and controls changes for new and marketed pharmaceutical drug substances and drug products, including chemical and biotechnological/ biological products. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-05-12/pdf/2021-09963.pdf?ref=fdaweb.com).