FDA Draft Guidance 'Considerations for Complying with 21 CFR 211.110'
- Date
- January 20, 2025
- Category
US Regulations
- Description
On the 4th of January 2025 FDA issued draft guidance titled “Considerations for Complying with 21 CFR 211.110”. Comments should be sent to FDA by 4 July 2025.
21 CFR 211.110 is the part of the US GMPs that gives requirements for ‘Sampling and testing of in-process materials and drug products’. This new draft guidance discusses related quality considerations for drug products that are manufactured using advanced manufacturing. This guidance also describes considerations for the use of advanced manufacturing (e.g., 3D printing, continuous manufacturing) and the use of process models as a part of commercial manufacturing control strategies.
The draft guidance has two main sections:
III. General considerations for in-process sampling and testing and
IV. Additional considerations for advanced manufacturing and process models
In the section on ‘Additional considerations for advanced manufacturing’ the draft states that “Manufacturers should have robust understanding of the process, including system dynamics. This will help manufacturers ensure that the sampling frequency is sufficiently representative to draw a statistically valid conclusion about the quality of the in-process materials and the drug product.”
With regard to the use of process models alone to meet the requirements of 211.110, the draft states that, in the view of the FDA, current process models cannot ensure the continued validity of all of the model’s underlying assumptions at all times, particularly during certain unplanned disturbances. Therefore, control strategies that rely solely on current process models would be insufficient to satisfy the requirements of § 211.110.
The draft guidance can be found at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-complying-21-cfr-211110.