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Why Design Controls Matter for Combination Products
Design controls represent one of the most significant regulatory challenges for companies entering the combination product market, especially those with a pharmaceutical or biologics background.
Key Regulatory Frameworks Involved
Pharma companies are well-versed in process validation under GMPs (21 CFR Part 210/211). However, combination products that include a device component require adherence to device regulations under 21 CFR Part 820, which mandates design controls.
What’s Required Under Design Controls?
Design controls involve structured development planning and documentation, including:
- Design and development planning
- User needs and design inputs
- Design outputs and verification
- Design validation (often including human factors/usability testing)
- Design transfer
- Design history files (DHF)
The Importance of Human Factors and Validation Testing
These are not just technicalities—they’re critical quality elements the FDA uses to determine whether a product will perform as intended when used by real patients. One of the most commonly misunderstood areas is design validation, which often requires human factors testing to confirm that the user can safely and effectively operate the device component.
How to Integrate Design Controls into a Pharma QMS
For many drug companies, integrating these design requirements means:
- Creating new SOPs for design and development
- Training teams on device regulations
- Hiring or consulting with medical device experts
Get Help From Combination Product Experts
RCA offers deep expertise in integrating design controls into pharmaceutical systems. Whether you need support with SOP development, training, or validation planning, RCA is here to help. Contact us today to learn more.
