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Defined under US FDA 21 CFR 3.2 (e)(2), a co-packaged combination product consists of “two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products”. (1) These device products can range from delivery devices, to bandages, to antimicrobial swabs. Understanding the regulations around such a wide range of devices can be challenging; drug companies often look to the device manufacturer/provider for guidance when filing.
In the past, often referencing a specific device registration such as a 510(k) was sufficient. Today things are different; expectations have expanded well beyond just the Design History File for a device alone. Consideration must be made for the device and drug to work as a “system.” Evaluation for functionality, compatibility and human factors must demonstrate that the device and drug work together with a successful outcome. Testing must be designed to account for the preparation and administration of a drug using all intended components and materials. This, of course, would include any primary containment system components such as vials and stoppers, and/or syringes. Testing should consider actual drug product, or drug product and diluent if a reconstitution step is required; and it should be conducted per industry standards (ISO, USP, ASTM, etc.) whenever possible. However, standards may not exist for every device/drug combination. In such a case, testing must be designed to evaluate all the critical parameters of the drug preparation and delivery process, and if possible, should be based upon, or reference, an industry standard.
Devices, now more than ever, play a critical role in many drug applications. A co-packaged combination product must be evaluated as a system, not just as individual components, and it will require testing that demonstrates successful drug delivery. As a global device developer and manufacturer, as well as contract analytical services provider, West offers the unique experience and expertise necessary for designing and executing studies to support co-packaged combination products. Contact the West Technical Customer Support team or visit the Reconstitution Systems section of our website to learn more.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.