Customer Requirement
A multinational pharmaceutical corporation (MNC) engaged in the manufacturing of therapeutics, food supplements, nutrition products, and treatments for nervous and respiratory systems, approached DDReg to conduct a comprehensive audit of its pharmacovigilance (PV) system. The audit was focused on evaluating the PV system being maintained at the company’s headquarters. The client also sought expert consultation to support preparations for upcoming PV inspections. The audit aimed to collect and assess objective evidence to determine how effectively the audit criteria for pharmacovigilance activities, outlined in the Safety Data Exchange Agreement (SDEA) between the company and its clients were being met.
Problem Statement
Although the client had an operational PV system, concerns were raised about its compliance with regulatory requirements and internal procedures. They needed an independent evaluation to identify any gaps that could lead to findings during regulatory inspections. The client wanted to ensure that the PV activities were fully aligned with the obligations defined in their SDEA.
Key Objective
To conduct a systematic, independent audit to identify major and minor non-compliances in the PV system and provide practical recommendations to ensure the company was inspection-ready and aligned with global pharmacovigilance expectations.
DDReg Solutions & Processes Adopted
DDReg deployed a seasoned pharmacovigilance auditor to perform a two-day comprehensive assessment. The audit followed a structured approach to evaluate processes, documentation, data integrity, SOP adherence, and safety follow-up procedures. The findings were categorized as follows:
- Major Observation:
- Deviation not raised for the late submitted case.
- Minor Observations:
- Regulatory Intelligence (RI) was not covered in any SOP of the auditee firm.
- Insufficient gap between SOP approval and its effective date, leaving inadequate time for staff training.
- Data integrity issues such as missing signatures, missing dates, and usage of uncontrolled forms.
- Missing annexure in the PSUR
- Adverse event follow-up was not conducted as per internal SOP guidelines.
In addition to identifying these issues, DDReg’s expert provided actionable and pragmatic recommendations to enhance the robustness of the PV system:
- SOP versions should be reviewed and updated at least every 3 years.
- The duration between audit completion and issuance of the audit report should not exceed 30 days.
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Business Impact
The audit report was well received by the client. All minor observations were successfully addressed prior to the scheduled PV inspection. For observations requiring longer-term solutions, a detailed corrective and preventive action (CAPA) plan was developed and accepted. As a result, the client’s inspection proceeded smoothly, with minimal findings. The proactive approach and in-depth recommendations provided by DDReg helped the client align their PV system with regulatory expectations, ensuring inspection readiness and demonstrating compliance.
Key Learning
Proactive pharmacovigilance system evaluations can reveal critical gaps that might otherwise result in regulatory findings. Timely PV audits, expert guidance, and structured follow-up actions are essential to maintaining an inspection-ready PV system and ensuring patient safety.
Read more case studies from DDReg Experts here: Addressing Regulatory Query with Expert PK Reanalysis & Justification