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Standard Operating Procedure for Drug-Device Combination Products Oversight

Purpose

The purpose of this SOP is to establish standardized oversight procedures for clinical trials involving drug-device combination products. It ensures that both drug and device components are managed, documented, and monitored in compliance with global regulatory requirements, maintaining subject safety and data integrity.

Scope

This SOP applies to sponsors, investigators, CROs, vendors, and site staff engaged in the conduct of drug-device combination clinical trials. It covers accountability, labeling, storage, calibration, quality oversight, safety monitoring, adverse event reporting, and regulatory submissions.

Responsibilities

• Sponsor: Ensures oversight of drug-device combination products, including regulatory compliance and quality management.
• Investigator/Site Staff: Maintain accountability and logs for both drug and device components.
• CRO: Monitors site compliance and supports sponsor oversight.
• QA: Audits documentation and verifies compliance with GCP.
• Vendors: Provide calibration, labeling, and certification support.

Accountability

The Sponsor’s Quality Lead is accountable for ensuring drug-device combination product compliance. Investigators are accountable for site-level management of products. QA is accountable for verification and audit readiness.

Procedure

1. Product Receipt and Accountability
1.1 Record receipt of drug-device products in the Combination Product Accountability Log (Annexure-1).
1.2 Verify labeling, packaging, and integrity upon receipt.
1.3 Store products according to defined environmental conditions.

2. Labeling and Identification
2.1 Ensure labeling includes “For Clinical Trial Use Only” and UDI identifiers.
2.2 Document labeling in the Labeling Log (Annexure-2).

3. Storage and Handling
3.1 Store per drug storage guidelines (e.g., temperature, humidity) and device requirements (e.g., calibration status).
3.2 Restrict access to authorized personnel only.

4. Calibration and Maintenance
4.1 Ensure device components undergo calibration per manufacturer requirements.
4.2 Record activities in Calibration and Maintenance Log (Annexure-3).

5. Risk Management
5.1 Conduct risk assessment for drug-device interactions and trial-specific risks.
5.2 Document in Risk Assessment Log (Annexure-4).

6. Safety Monitoring and AE Reporting
6.1 Monitor both drug and device components for adverse events or malfunctions.
6.2 Report adverse events, device deficiencies, and malfunctions to sponsor, EC/IRB, and regulators as applicable.

7. Regulatory Submissions
7.1 Submit required documentation for combination products to FDA, EMA, CDSCO, or other authorities.
7.2 Maintain submission records in Regulatory Submission Log (Annexure-5).

8. Archiving
8.1 Archive all accountability, labeling, and safety records in TMF/ISF.
8.2 Retain as per regional archiving regulations.

Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• CRO: Contract Research Organization
• TMF: Trial Master File
• ISF: Investigator Site File
• AE: Adverse Event
• UDI: Unique Device Identification
• FDA: Food and Drug Administration
• EMA: European Medicines Agency
• CDSCO: Central Drugs Standard Control Organization
• WHO: World Health Organization

Documents

1. Combination Product Accountability Log (Annexure-1)
2. Labeling Log (Annexure-2)
3. Calibration and Maintenance Log (Annexure-3)
4. Risk Assessment Log (Annexure-4)
5. Regulatory Submission Log (Annexure-5)

References

• FDA – Combination Products Guidance
• EMA – Clinical Trials with Combination Products
• CDSCO – Combination Product Regulations
• ICH GCP – Combination Products Oversight
• WHO – Global Oversight of Combination Trials

Version: 1.0

Approval Section

Annexures

Annexure-1: Combination Product Accountability Log

Annexure-2: Labeling Log

Annexure-3: Calibration and Maintenance Log

Annexure-4: Risk Assessment Log

Annexure-5: Regulatory Submission Log

Revision History

For more SOPs visit: Pharma SOP