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FDA Publishes Manual on Review of Type III DMFs for Packaging Materials

Apr 6, 2010

The U.S. Food and Drug Administration (FDA) published a Manual of Policies and Procedures (MAPP) on March 22, 2010 that standardizes policy within the Office of Pharmaceutical Science (OPS) for review of chemistry, manufacturing, and controls (CMC) information on certain packaging materials in Type III drug master files (DMFs). The document (No. 5015.5), titled, "CMC Reviews of Type III DMFs for Packaging Materials," specifically addresses when a written review of a Type III DMF should be prepared and how the FDA reviewer should determine whether the information in the DMF and the application it supports satisfies the requirements for assessing the safety of certain packaging systems. This information can also be helpful to submitters in including appropriate information in their DMFs.

More information on DMFs can be found in the PackagingLaw.com article, "Beyond Food Packaging: Customer Assurance for Drugs, Medical Devices, Cosmetics, Tobacco, and Toys."