This week, I’m at the 2014 PDA Universe of Prefilled Syringes and Injection Devices and 2014 PDA Drug Delivery Combination Products Workshop. Only two talks have “QbD” in their titles. The good news is that QbD jargons and practices are beginning to show up in other sessions.
Earlier at IFPAC 2014, McDermott and Chatterjee shared FDA’s QbD case study on Drug Eluting Stents.
Having worked on Drug Eluting Stents in the past, this caught my attention.
Then my question was:
Will FDA promote QbD in Medical Devices or Combination Products?
as the agency has done so for Pharmaceuticals and Biopharmaceuticals.
Dr. Chatterjee’s answer was along the line of let’s wait and see.
I admit this is difficult to answer for the following reasons:
- Drugs and Devices are governed by separate FDA departments. CDER (Center for Drug Evaluation and Research) and CBER (Center for Biologics Evaluation and Research) govern Drugs whereas CDRH (Center for Device and Radiological Health) governs Devices. For combination products, both are involved.
- Devices industry already has a development framework called the Design Controls. Since 1997, CDRH has enforced the Device manufacturers to follow a Quality Systems to:
- Establish a design plan which is based on intended use and design inputs (similar to QTPP and CQA)
- Translate the design into manufacturing specifications (similar to CQA and CPP)
- Periodically review design throughout the development process (similar to risk assessment and risk management)
- Confirm that the design outputs conform to the design inputs through: (similar to validation)
- Design verification (“did we design the device right?”)
- Design validation (“did we design the right device?”)
- Document the entire process using a design history file (DHF)
As such, the decision to go “QbD” or not for Devices is uncertain due to political and historical backgrounds.
Here’s my prediction: QbD will influence the Devices industry but FDA will have to reconcile the differences between QbD and Design Controls. Perhaps both frameworks will merge under one title in the future as combination products become more common.
In fact, FDA’s move toward Office of Pharmaceutical Quality (OPQ) may be a positive signal toward such a trend of consolidation.
OPQ will include:
- Office of Operations
- Office of Policy
- Office of New Drug Products
- Office of Lifecycle Drug Products
- Office of Process and Facilities
- Office of Surveillance
- Office of Testing & Research
- Office of Biotechnology Products
After the conference, I will share more details on the QbD trends taking place in the devices industry. So please come back to follow up.
Are you using QbD for Medical Devices, Pre-filled Syringes, Combination Products? If so, share your case studies or insights with us!