Considerations for Complying With 21 CFR 211.110; Draft Guidance for Industry; Availability
Published Date: 1/6/2025
Rule
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!
Analyzed Economic Effects
4 provisions identified: 3 benefits, 1 costs, 0 mixed.
Process Models Alone Not Allowed
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
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 manufacturing and encourages manufacturers to discuss innovative control strategies with the Agency.
Draft FDA Guidance Released
The FDA published a draft guidance called "Considerations for Complying with 21 CFR 211.110" that applies to the manufacture of human drug products (including biologics) and animal drug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 The FDA is accepting comments on the draft guidance through April 7, 2025.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 binding) and explains how to ensure batch uniformity and drug product integrity under 21 CFR 211.110.
Who Is Covered — Key Exclusions
The draft guidance applies to the manufacture of human drug products (including biological products) and animal drug products but does not apply to the manufacture of active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 guidance.
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