Drugs

Guide on Drug Batch Uniformity and Integrity

FDA has released a draft guidance entitled “Considerations for Complying With 21 CFR 211.110” that describes how to comply with batch uniformity and drug product integrity requirements. In addition, it discusses related quality considerations for drug products that are manufactured using advanced manufacturing, and how manufacturers can incorporate process models into commercial manufacturing control strategies.

FDA notes that all manufacturers should “apply a scientific- and risk-based approach to controlling processes and ensuring drug product quality. This approach should be based on robust product and process understanding. Manufacturers must maintain the process in a state of control over the life of the process to ensure drug product quality, even as materials, equipment, production environment, personnel, and manufacturing procedures change.”

The document says that having a system that monitors process performance and drug product quality helps ensure that a state of control is maintained, and it ensures that processes and controls are continuously capable of producing a quality drug product and identifies areas for continual improvement. It also covers requirements for written procedures “that describe the in-process controls, and tests, or examinations to be conducted on appropriate samples of in-process materials of each batch.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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