USA – FDA releases compliance program for CDER, CDRH-led combination product inspections

In a newly issued compliance program, the US Food and Drug Administration (FDA) explains its approach to inspections of Center for Drug Evaluation and Research (CDER)- and Center for Devices and Radiological Health (CDRH)-led combination products.
 
The 46-page document lays out FDA’s intended implementation of the compliance program; inspectional operations and reporting considerations; sampling and analytical testing expectations; regulatory and administrative strategy; and an explanation of center responsibilities.
 
FDA says the compliance program focuses mainly on single-entity and co-packaged combination products that feature drug and device or biological product and device constituent parts.
 
Combination product manufacturers may demonstrate compliance with current good manufacture practice (CGMP) requirements through one of two ways: compliance with all applicable CGMPs or by following a streamlined approach in which drug CGMPs or device quality system regulation and specific “called-out provisions” are followed.
 
“Because most combination product manufacturers use a streamlined approach, this compliance program focuses on inspections of compliance with the base CGMPs plus the called-out provisions specified in 21 CFR Part 4,” FDA writes. FDA also explains that combination products should generally follow the practices of the lead center and base compliance program in addition to “commodity-specific” compliance programs, which are referenced in the document…