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# Time to Update FDA SUPAC Guidances
- URL: https://www.fdaweb.com/time-to-update-fda-supac-guidances/
- Published: 2026-03-03T12:00:00.000Z
- Updated: 2026-09-14T13:34:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160748

FDA is seeking public input on whether to revise a longstanding series of manufacturing guidance documents that govern how drugmakers manage postapproval changes to their products. Comments are being sought on updating the agency’s Scale-Up and Postapproval Changes (SUPAC) guidances, which outline a risk-based framework for evaluating chemistry, manufacturing and controls (CMC) changes to approved drug applications.

The SUPAC guidances, finalized between 1995 and 1997 — with a Manufacturing Equipment Addendum updated in 2014 — cover specific dosage forms, including immediate-release solid oral products (SUPAC-IR), modified-release products (SUPAC-MR), and nonsterile semisolid dosage forms (SUPAC-SS). They describe recommended testing and documentation when companies make changes to components, manufacturing processes, equipment, scale, or production sites.

FDA notes the guidances were developed after workshops and agency-sponsored research in the 1990s to establish a risk-based approach to postapproval CMC changes. While the agency says the core principles of the SUPAC program remain relevant, it acknowledged that advances in pharmaceutical science and quality risk management tools may warrant updates. In particular, FDA noted potential overlap or tension between SUPAC recommendations and more recent international standards such as ICH Q9(R1) on quality risk management and ICH Q12 on postapproval lifecycle management.

“Since \[the guidances were finalized\], the use and evolution of risk assessment tools in pharmaceutical development has enhanced the ability to identify, categorize, and control risks associated with a CMC change,” the agency writes in a *Federal Register* [notice](https://www.federalregister.gov/documents/2026/03/03/2026-04196/recommendations-on-scale-up-and-postapproval-changes-guidances-for-industry-request-for-comments?ref=fdaweb.com). FDA says it is considering revisions to ensure the documents reflect current scientific and technical expectations and align with modern pharmaceutical quality systems.

The notice poses a series of detailed questions to industry and other stakeholders. Among them: which sections of the SUPAC guidances remain helpful; whether any portions are outdated or should be removed; whether manufacturers can readily determine the appropriate reporting category for a given change; and whether the agency should reorganize or consolidate the documents to improve clarity.

FDA is also asking whether additional topics should be added and how the SUPAC framework can better align with contemporary tools such as postapproval change management protocols and the concept of “established conditions” described in ICH Q12.

The agency is requesting feedback by 6/1 before beginning work on any potential updates.