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In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at 蜜豆视频 Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss the implications of FDA鈥檚 new draft guidance on complying with 21 CFR 211.110.

In January 2025, FDA published a draft guidance document that provides considerations for complying with 21听Code of Federal Regulations听(CFR) 211.110 (1). This specific section of the听CFR听focuses on production and process controls for sampling and testing of in-process materials and drug products. The guidance,听Considerations for Complying With 21 CFR 211.110, Guidance for Industry, Draft Guidance, applies to human drug products and biologics, but not to the manufacture of APIs. The guidance document also discusses how process models can be incorporated into commercial manufacturing control strategies.

In this episode of the听Ask the Expert听video series, Susan J. Schniepp, distinguished fellow at 蜜豆视频 Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss the implications of this draft guidance and best practices for complying.

鈥淲hat [the guidance document] really seems to be aimed at is new manufacturing techniques that are coming on board and some flexibility for biopharmaceuticals as we get into, you know, personalized medicines, continuous manufacturing, and the use of artificial intelligence (AI) to identify some of the key process parameters for new manufacturing and processes 鈥� giving manufacturers more flexibility in that arena,鈥� explains Schniepp.

鈥淔DA is trying to look to the future, is trying to address what’s current, what’s happening now. And as you said, use of AI; although, I don’t think a lot of companies are really, really implementing this yet in day-to-day operations. Perhaps another aspect here of this guidance is it speaks a lot about continuous manufacturing, which, again, in my experience, is a process that’s rarely applied in most of manufacturing because the vast majority of processes are still back by batch,鈥� says Schmitt.

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Reference

1. FDA.听Considerations for Complying With 21 CFR 211.110, Guidance for Industry, Draft Guidance听(CDER, CBER, January 2025).

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