FDA Warning Letter: Quality Unit Data Integrity for Sterile Products

Quality Unit (QU) data integrity issues are frequently cited in FDA Warning Letters, reflecting concerns that a company's quality system fails to adequately ensure the accuracy and integrity of data, which is crucial for the safety, effectiveness, and quality of drugs.

Required Data Integrity Remediation

The FDA typically requires the following actions to address data integrity deficiencies:

1. Hire a Third-Party Consultant:

Engage an independent third-party consultant to conduct a comprehensive investigation into data record inaccuracies and reporting issues across all laboratories, manufacturing operations, and other relevant systems.

2. Verify Data Integrity Deficiencies:

Verify the extent of data integrity problems, and identify issues such as omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies.

3. Perform Risk Assessment:

Evaluate the effect of data integrity, and conduct a current risk assessment to understand the potential effects of the observed failures on drug quality.

4. Implement Interim Measures:

Describe interim actions taken or planned to protect patients and ensure drug quality. This may include notifying customers, recalling products, and conducting additional testing.

5. Develop a Detailed Corrective and Preventive Action Plan:

Create a comprehensive plan outlining long-term measures. This plan should include remediation efforts and enhancements to procedures, processes, methods, controls, systems, management oversight, and human resources (e.g., training, staffing improvements) to ensure the data integrity.

Key Concern: Chief Integrity Officer

One critical point of concern is whether the company will appoint a Chief Integrity Officer. This officer should be fully empowered to receive anonymous complaints from employees regarding data integrity concerns, and ensure that any potential breaches are promptly investigated and addressed.

Data Governance Requirements

Data integrity is not a mere formality; it is a regulatory requirement. The FDA emphasizes the importance of robust data governance:

• Data governance system should be an integral part of pharmaceutical quality system.

• Data governance ensures the records and data are managed formally in the regulated company. It includes the personnel, process and technology required by consistent, accurate and effective data processing.

For detailed guidance on establishing and maintaining cGMP-compliant data integrity practices, refer to the FDA’s guidance document, Data Integrity and Compliance with Drug CGMP.

 https://www.fda.gov/media/119267/download