FDA: Guidance to Ensure Batch Conformity and Drug Product Integrity
The FDA has published Considerations for Complying with 21 CFR 211.110 for comment.
To ensure batch uniformity and drug product integrity, the current good manufacturing practice (CGMP) regulations require, among other things, that manufacturing processes are designed and controlled to ensure that in-process materials consistently and reliably meet predetermined quality requirements.
This guidance explains the requirements for drug product manufacturing in 21 CFR § 211.110. 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 FDA supports the use of advanced manufacturing as a foundation for improving the overall quality and availability of drug products for patients.
Comments can be submitted by 7 April 2025.
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