What Device and Combination Product Audits Cover
Medical devices and combination products sit at the intersection of device regulation and pharmaceutical GMP. A combination product, such as a prefilled syringe with a biologic, a drug eluting stent, or an inhaler with a drug, is regulated as a combination under frameworks that assign components to different regulatory pathways. The GMP requirements reflect that complexity.
An audit for these products assesses the device constituent, the drug constituent, and the interface between them. It covers design controls, risk management, manufacturing controls, sterilization, packaging, and the documentation that demonstrates the product meets its specifications and is safe for use.
The Regulatory Context
FDA 21 CFR Part 820 and the QMSR
The FDA regulates device quality through 21 CFR Part 820. The Quality Management System Regulation, or QMSR, will replace Part 820 and align more closely with ISO 13485. Combination products are assigned to a lead center, and the GMP requirements of both the drug and device frameworks may apply.
EU MDR 2017/745 and IVDR 2017/746
The EU Medical Device Regulation and In Vitro Diagnostic Regulation set requirements for device quality, clinical evaluation, and post market surveillance. For combination products, the medicinal product directive and GMP requirements may also apply.
ISO 13485
ISO 13485 is the international standard for medical device quality management systems. It is the basis for many regulatory requirements and is used in audits worldwide.
ICH Q9 and ISO 14971
Risk management for devices is addressed by ISO 14971, which aligns with the principles of ICH Q9. An audit should check that risk management is integrated into design and manufacturing.
Health Canada and MHRA
Health Canada regulates devices under the Medical Devices Regulations. The MHRA regulates devices under the UK MDR. Both have expectations for quality systems and post market surveillance.
What Audits Focus On
Design Controls
Design inputs, outputs, verification, validation, and design transfer. The audit should check that design controls are applied and documented.
Risk Management
Risk analysis, evaluation, control, and residual risk assessment. The audit should check that risk management is ongoing and integrated.
Manufacturing Controls
Process validation, equipment qualification, and production controls. For combination products, both drug and device manufacturing controls may apply.
Sterilization
Sterilization validation, routine monitoring, and sterility assurance. For devices and combination products, sterilization is often critical.
Packaging and Labeling
Packaging integrity, labeling content, and traceability. The audit should check that labeling meets the applicable requirements.
Supplier Controls
Supplier qualification and oversight for components and services. The audit should check that critical suppliers are controlled.
Post Market Surveillance
Complaint handling, adverse event reporting, and CAPA. The audit should check that post market information feeds back into design and manufacturing.
Interface Between Constituents
For combination products, the interface between drug and device is a specific risk area. The audit should check that compatibility, performance, and stability are addressed.
Common Findings
Design Control Gaps
Risk Management That Is Not Ongoing
Sterilization Validation Gaps
Supplier Controls That Are Not Risk Based
Post Market Surveillance Weaknesses
Interface Testing That Is Incomplete
Introducing GxP Cellators for Device and Combination Product Audits
GxP Cellators provides GMP audits for medical devices and combination products across design, manufacturing, sterilization, packaging, and post market surveillance. Our audits cover design controls, risk management, manufacturing controls, sterilization, packaging and labeling, supplier controls, post market surveillance, and the interface between constituents.
We work across FDA, EU MDR and IVDR, ISO 13485, Health Canada, and MHRA frameworks, and we adapt the audit scope to the product type and the regulatory pathway. Our auditors bring regulatory inspection and industry quality experience, and we deliver clear, prioritized reports with practical remediation guidance.
We also provide supplier and vendor audits for device components and services, and mock inspections for sites preparing for regulatory inspection.
Strengthen Device and Combination Product Compliance
Visit https://www.gxpcellators.com/gmp-auditing/ for service details. Email or use https://www.gxpcellators.com/contact/ to discuss your audit.
Frequently Asked Questions About Device and Combination Product Audits
What is a combination product?
A combination product combines a drug, device, or biologic. Examples include prefilled syringes, drug eluting stents, and inhalers.
Which regulations apply to combination products?
The applicable regulations depend on the jurisdiction and the product. In the US, both drug and device frameworks may apply. In the EU, the MDR and medicinal product requirements may apply.
What is the QMSR?
The Quality Management System Regulation will replace 21 CFR Part 820 and align more closely with ISO 13485.
Do you audit design controls?
Yes. Design inputs, outputs, verification, validation, and transfer are part of the audit scope.
How do you assess sterilization?
We review sterilization validation, routine monitoring, and sterility assurance, including the applicable standards.
Can you audit suppliers of device components?
Yes. Supplier and vendor audits cover device components and services, with risk based oversight.
How do I request a device or combination product audit?
Email or use https://www.gxpcellators.com/contact/. Service details are at https://www.gxpcellators.com/gmp-auditing/.
