# 2024-31356: Considerations for Complying With 21 CFR 211.110; Draft Guidance for Industry; Availability

2024-31356, Considerations for Complying With 21 CFR 211.110; Draft Guidance for Industry; Availability, is a Federal Register rule from an unnamed agency published 2025-01-06, effective Submit comments by April 7, 2025 (as of 2026-06-11).

- Canonical: https://policyrisk.com/federal-register/2024-31356
- As of: 2026-06-11
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2024-31356
- Title: Considerations for Complying With 21 CFR 211.110; Draft Guidance for Industry; Availability
- Type: Rule
- Agencies: unknown
- Citation: unknown
- Published: 2025-01-06
- Effective: Submit comments by April 7, 2025
- Comments close: not stated
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-11

## Summary

The FDA just dropped a draft guide to help drug makers keep their products safe and consistent, especially when using cool new manufacturing tech. If you’re in the pharma biz, this is your chance to weigh in before April 7, 2025. Following these tips could save time and money by avoiding costly mistakes down the road!

## Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Considerations for Complying With 21 CFR 211.110." This guidance, when finalized, will describe considerations for complying with the requirements for ensuring batch uniformity and drug product integrity. In addition, this guidance discusses related quality considerations for drug products that are manufactured using advanced manufacturing. FDA is committed to supporting and enabling pharmaceutical innovation and modernization as part of the Agency's mission to protect and promote the public health. FDA encourages industry representatives and manufactures who are interested in using innovative control strategies to contact the Agency.

## Effects PRIA read

- Draft FDA Guidance Released: benefit, low. The FDA published a draft guidance called "Considerations for Complying with 21 CFR 211.110" that applies to the manufacture of human drug products (including biologics) and animal drug products. The FDA is accepting comments on the draft guidance through April 7, 2025. This guidance is draft (not…
- Process Models Alone Not Allowed: cost, medium. The FDA says control strategies that rely solely on current process models are insufficient to meet 21 CFR 211.110. Manufacturers must pair process models with in-process material testing or process monitoring as part of their commercial manufacturing control strategies.
- Advanced Manufacturing Encouraged: benefit, medium. The guidance discusses advanced manufacturing methods (for example, 3D printing and continuous manufacturing) and states these approaches generally lend themselves to better process understanding and are suitable for using process models as part of control strategies. FDA says it supports advanced…
- Who Is Covered — Key Exclusions: benefit, low. The draft guidance applies to the manufacture of human drug products (including biological products) and animal drug products but does not apply to the manufacture of active ingredients. Positron emission tomography (PET) drug products are subject to 21 CFR part 212 and are not covered by this guid…

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## Sources
- [2024-31356 on federalregister.gov](https://www.federalregister.gov/documents/2025/01/06/2024-31356/considerations-for-complying-with-21-cfr-211110-draft-guidance-for-industry-availability)
- [2024-31356 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-01-06/pdf/2024-31356.pdf)

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- [Next: 2024-31358, Immigration Bond Notifications](https://policyrisk.com/federal-register/2024-31358)
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Source: PRIA, https://policyrisk.com/federal-register/2024-31356 (as of 2026-06-11).