January 11, 2017
Authored and Edited by Scott A. Allen; Bryan C. Diner
On January 11, 2017, the FDA released nonbinding Final Guidance on Current Good Manufacturing Practice (CGMP) Requirements for Combination Products. The FDA intends the Guidance to define “combination products” and describe its January 2013 final rule on CGMP requirements (21 C.F.R. Part 4), which outlined for the first time the application of CGMP requirements to combination products. The Guidance includes an explanation of how manufacturers can implement CGMP requirements using a “streamlined approach” to quality management systems for some combination products instead of maintaining separate quality systems specific to each underlying part of the combination.
The Guidance first defines a “combination product” as “a product composed of two or more different types of medical products,” which “are referred to as ‘constituent parts’ of the combination product.” Importantly, the Guidance reiterates that constituent parts retain their separate regulatory status even after they are combined together and that CGMP requirements that apply to each constituent part apply to the combination. For most single-entity combination products and co-packaged combination products, however, the Guidance sets forth and clarifies two different options for demonstrating compliance with CGMP requirements.
Under the first option, manufacturers must separately demonstrate compliance with all CGMP regulations applicable to each constituent part of the combination. In the second “streamlined” option, most manufacturers of single-entity and co-packaged combination products may demonstrate compliance with either the drug CGMP requirements under 21 C.F.R. Parts 210 and 211 or the device Quality System Regulation under 21 C.F.R. Part 820, along with compliance with certain specific provisions from the other set of requirements. The final rule identifies the specific additional provisions that must be implemented as part of the streamlined option, including requirements unique to combination products with biologic or cellular and tissue parts. As illustration, the Guidance walks through hypothetical scenarios for streamlined implementation of CGMP requirements for three different combination products: pre-filled syringes, drug-eluting stents, and drug-coated mesh.
For some other combination products, such as cross-labeled combination products, the streamlined approach outlined in the Guidance may not be applicable. For instance, each constituent part of a cross-labeled combination product remains subject to all CGMP requirements for each separate constituent part, unless those parts are manufactured at the same facility. The Guidance states that the FDA does not intend to object to a streamlined approach for cross-labeled combination products manufactured in the same facility because the process would be akin to the process for co-packaged combination products.
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