Are you up to speed with the cGMP requirements for combination products?

In January of this year, the FDA issued its final guidance governing current Good Manufacturing Practice requirements for combination products. The draft guidance was first issued in January of 2015, and the final version includes changes made by FDA that address areas of confusion noted by manufacturers; especially those regarding the “streamlined approach” to compliance under 21 CFR 4.4(b). The streamlined approach provides that combination product manufacturers may meet the requirements of both the drug cGMPs and device QS regulations by designing and implementing an operating system that demonstrates compliance with either of the following: all of the drug cGMPs specified in 21 CFR 210 and 211 plus specific sections of the device Quality System regulations specified in 21 CFR 820, OR, all of the device QS requirements and specific sections of the drug cGMPs. Interestingly, the selection of which streamlined approach a manufacturer chooses to follow is independent of the primary mode of action of the combination product. This gives companies some leeway in selecting regulations that fit their existing procedures. As a result, a device manufacturer venturing into the combination products space will likely choose to comply with all of 21 CFR 820, since they already have those systems in place, and adopt the necessary parts of 21 CFR 210, 211. Drug manufacturers looking at combination products will likely take the opposite path, and choose the cGMP drug based streamlined approach. For more information on this important regulatory subject view the attached presentation.

The entire guidance can also be downloaded from the FDA website: