GMPs for Combination Drug-Device Products – Understanding Compliance Requirements for Each Component

EAS published an article in MedTech Intelligence on the importance of component GMP requirements for drug-device combination products.

“The rapid development of combination products—biologics, pharmaceuticals and their devices—provides great opportunity for technological advancement, opening new doors for patient health and improved compliance with administration requirements. The complexity of these systems often requires the device to be developed alongside the drug that it will contain. Whether wearables, injectables or transdermal delivery systems, concerns of maintaining a firm grip on quality and stability throughout the design, manufacturing and product lifecycle process means understanding the GMP requirements of each component. Both are critical to product and compliance success.

Combination drug/device products as defined by FDA’s 21 CFR part 3 must comply with 21 CFR part 4 subpart A, current Good Manufacturing Practice (GMP) requirements for combination products (see January 2017 Final Guidance, Current Good Manufacturing Practice Requirements for Combination Products). Whether approved by CDRH, CDER or CBER, (generally only one approval is required based on the product’s most “significant” attribute or mode of action), device design controls (21 CFR part 820.30) must confirm there are no negative interactions between constituent parts and assure the combination product is safe and effective, performing as expected. Additionally, pharmaceutical quality must also address product design and development procedures, so it is critical that both sets of requirements are coordinated in the design and development stage. A reminder that cGMPs are minimum standards by which products shall be manufactured.

Oftentimes during development of combination products each product side understands their own regulatory requirements better than that of their combination component.”