About Combination Products

Companies who market a combination product in the US face specific challenges to get and keep their products regulatory compliant. Although no new requirements are added, the scope for conforming with the requirements is changed considerable.

FDA introduced current good manufacturing practice (cGMP) requirements for combination products. A combination product is a combination of two or three different types of the following regulated products: a biological product, a drug, a medical device. FDA recognizes four types of combination products: single entity, co-packaged, cross-labelled, (investigational) cross-labelled.

Manufacturers Challenges

There are two ways to conform with the regulations: Ensure conformity of the combination product by applying all cGMP regulations applicable to each of the parts, OR by only applying the cGMP regulations of one of the parts.

However manufacturers must ensure the following: If parts - drug, biologic, device, HCT/Ps - are combined in a combination product, each individual part keeps its own cGMP requirements for conformance! If any conflict or ambiguity appears, you follow the most specifically applicable regulation.

What unfamiliar compliance requirements will traditional pharma companies face?

And what unfamiliar compliance requirements will traditional device manufacturers face?

Some points to address

  • To whom these requirements apply?
  • How to classify your drug or device to set the right tone for your development and application?
  • What cGMP and QS requirements must be addressed?
  • How to approach gaps in your current quality system
  • How to implement and maintain a successful and compliant QMS for combination products?
  • How to know what to correct or remediate?
  • How to prevent corrections have more widespread implications than initially thought?
  • How to prevent new gaps may occur or existing gaps may no longer be addressed?
  • How to know how detailed the device part needs to be in a drug PMOA combination product submission?