NEWS: Packaging for Combination Products

Industry has asked FDA to clarify terms in its draft guidance on current good manufacturing practice for combination products. Respondents have questioned the terms “joining together” and “marketed,” because the agency seems to be suggesting packaging but does not state so.

In the guidance, FDA defines a combination product as one composed of “any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.” These components could be “physically, chemically, or otherwise combined or mixed and produced as a single entity;” separate products “packaged together in a single package or as a unit;” or packaged separately but intended to be used together.

(New York City) questions the agency’s use of the phrase “during and after joining together” in a letter to FDA on December 3. “At a manufacturing site,” writes Maria Guazzaroni, director/team leader, regulatory monitoring, for Pfizer’s global quality operations, this phrase “could be the point at which constituent parts are received and approved for manufacturing, or when the constituent parts are loaded into hoppers on an assembly or packaging line.” Eli Lilly’s vice president of quality, Frank Deane, also questions this phrase in his letter dated December 1.

Deane also asks the agency to explain the term “marketed” in the phrase “combination products with constituent parts that are separately marketed together but intended to be used together.” For instance, writes Deane, “one possible scenario is that the two constituents of the combination product may have to be stored at different temperatures and distributed separately. So the constituent parts are not marketed separately. They may be supplied in separate packages but they will be marketed together. We suggest the word ‘marketed’ be changed to ‘packaged’ as stated in 21 CFR 3.2 (e)(3) and (4) for the definitions of combination products.”

Clarifications are needed for packaging professionals because they need to know at what point in their operations they need to follow GMPs for pharmaceuticals or medical devices, products or both, for instance.

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