💊FDA Draft Guidance on Complying with 21 CFR 211.110 Available
Considerations for Complying With 21 CFR 211.110; Draft Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Considerations for Complying With 21 CFR 211.110." This guidance, when finalized, will describe considerations for complying with the requirements for ensuring batch uniformity and drug product integrity. In addition, this guidance discusses related quality considerations for drug products that are manufactured using advanced manufacturing. FDA is committed to supporting and enabling pharmaceutical innovation and modernization as part of the Agency's mission to protect and promote the public health. FDA encourages industry representatives and manufactures who are interested in using innovative control strategies to contact the Agency.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The draft guidance addresses compliance requirements for batch uniformity and drug product integrity under 21 CFR 211.110, impacting pharmaceutical manufacturers. It encourages adopting advanced manufacturing techniques and establishes risk-based control strategies, directly affecting operational standards and regulatory compliance protocols.