From: Stability considerations for drug-device combination products-21 CFR part 4 update
Product Type | Part 4 requirements |
---|---|
Combination Product includes a drug constituent part | The CGMP requirements identified under 4.3(a) will apply to the combination product, which follows 21 CFR 210–211 |
Combination Product includes a device constituent part | The CGMP requirements identified under 4.3(b) will apply to the combination product, which follows 21 CFR 820 |
Manufacture of a constituent part of a co-packaged or single entity Combination Product occurs at a separate facility | The CGMP system of the constituent part manufactured at that facility must comply with all CGMP requirements applicable to that constituent part |
Combination Product contains multiple constituents | CGMP system must comply with the specifics of applicable provisions of all constituent parts, or based on the Primary Mode of Action (PMOA), a streamlined approach can be utilized |
If there are conflicts among the CFR requirements | The regulations most specifically applicable to the constituent will supersede the more general ones |