Checklists for Compliance with Pharmacovigilance Regulations

Introduction
Compliance with pharmacovigilance (PV) regulations is a cornerstone of ensuring drug safety and maintaining trust with regulatory authorities. This expanded checklist provides detailed, actionable steps to set up and manage a robust PV system, ensuring adherence to global standards while protecting patients.

Checklist for PV System Setup

1. Create a Comprehensive Pharmacovigilance System Master File (PSMF)
   • Include a detailed description of your pharmacovigilance processes, safety data systems, and team roles.
   • Ensure accessibility for regulatory inspections.
2. Appoint and Train a Qualified Person Responsible for Pharmacovigilance (QPPV)
   • Verify that your QPPV fulfills legal qualifications and maintains knowledge of regulations.
3. Develop Standard Operating Procedures (SOPs)
   • Document detailed workflows for AE reporting, signal detection, risk management, and regulatory reporting.
4. Implement Robust Safety Databases
   • Use validated safety systems compliant with international standards like ICH and ISO for ICSR management.

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Checklist for Case Processing

1. Establish clear processes for collecting, validating, and assessing Individual Case Safety Reports (ICSRs).
2. Ensure adherence to expedited and periodic reporting timelines (e.g., 15 days for serious AEs).
3. Validate the completeness of safety data to avoid regulatory discrepancies.

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Checklist for Risk Management

1. Prepare and Maintain Risk Management Plans (RMPs)
   • Update RMPs regularly to reflect new safety data.
2. Monitor Benefit-Risk Profiles
   • Conduct periodic evaluations to ensure the benefits outweigh potential risks.
3. Implement Risk Minimization Strategies
   • Deploy tailored measures for specific products, such as additional labeling or targeted education.

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Checklist for Regulatory Reporting

1. Submit Periodic Safety Update Reports (PSURs) or PBRERs within required intervals.
2. Comply with country-specific requirements for expedited reporting of serious AEs.
3. Maintain documentation and timelines for all regulatory submissions.

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Checklist for Inspections and Audits

1. Conduct regular internal audits to ensure compliance with Good Pharmacovigilance Practices (GVP).
2. Keep records inspection-ready, ensuring accurate data is easily retrievable.
3. Act on identified gaps through Corrective and Preventive Actions (CAPAs).

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Conclusion

By systematically following this checklist, organizations can stay compliant, reduce risks, and safeguard patient safety while satisfying local and global pharmacovigilance regulations requirements.

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