Industry experts are stressing that the payoff for combination products in understanding and bridging the drug/biologic/device terminology differences is a smoother development process, a simpler, more effective control system, and better communications with CMC reviewers and GMP inspectors.
The challenge is to tighten the linkages between risk management and the control strategy for combination products. To do so, the experts are cautioning, the people involved – who may have previously thought in either the drug quality-by-design (QbD) or device design control vernaculars alone – have to become “bilingual.”
The different terminologies at play for drugs and devices need to be understood and interpreted. Also needed is an understanding of common terms like “criticality,” “functionality,” “specifications,” “validation” and “risk” in the separate contexts in which they were developed for drugs and devices, and how they can be meaningfully translated in the combination product context.
Janssen’s Mead Sheds Light on Melding Drug/Device Requirements
Janssen Combination Product Global Regulatory Affairs Senior Director Doug Mead is among those who have been shedding light recently on what these drug/device regulatory melding challenges look like, how they can be addressed, and what the rewards are for doing so.