Skip to main content

Table 3 Summary of the Essential CGMP Requirements that Apply to Combination Products with Various Constituent Parts

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