Guidelines for Pharmacovigilance Quality Control Checks

1) Purpose

The purpose of this SOP is to establish procedures for conducting quality control checks in pharmacovigilance to ensure data accuracy, completeness, and compliance with regulatory requirements.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in quality control checks, including quality assurance officers, pharmacovigilance specialists, and pharmacovigilance managers.

3) Responsibilities

The Quality Control Team is responsible for conducting systematic checks on pharmacovigilance activities, including case processing, data entry, coding, and reporting. The Pharmacovigilance (PV) Manager oversees the process to ensure adherence to standards and regulatory guidelines.

4) Procedure

4.1 Case Processing Quality Checks

1. Review a sample of processed cases to verify accuracy and completeness of data entry.
2. Assess compliance with internal procedures and regulatory requirements.
3. Document findings and discrepancies identified during the review.

4.2 Data Entry Verification

1. Verify data entered into the pharmacovigilance database against source documents.
2. Ensure consistency and accuracy of data entry across all fields.
3. Address any discrepancies or errors identified during verification.

4.3 Coding Accuracy Checks

1. Review coded adverse events using standard coding dictionaries (e.g., MedDRA).
2. Verify the accuracy and consistency of coding assignments.
3. Ensure coding complies with regulatory requirements and internal guidelines.

4.4 Report Review and Compliance

1. Review pharmacovigilance reports, including periodic safety update reports and expedited reports.
2. Ensure reports are comprehensive, accurate, and submitted within regulatory timelines.
3. Verify compliance with reporting requirements specified in pharmacovigilance agreements.

4.5 Documentation and Record Keeping

1. Maintain detailed records of all quality control checks conducted.
2. Document findings, corrective actions, and follow-up activities.
3. Ensure all documentation is securely stored and easily accessible for audits and inspections.

4.6 Quality Control Audits

1. Conduct periodic audits of pharmacovigilance processes and activities.
2. Assess compliance with SOPs, regulatory requirements, and industry best practices.
3. Report audit findings and recommendations for improvement to senior management.

4.7 Training and Communication

1. Provide training to pharmacovigilance staff on quality control procedures and standards.
2. Communicate updates to quality control processes and guidelines to ensure consistency in practices.
3. Facilitate knowledge sharing and continuous improvement in quality control practices.

5) Abbreviations, if any

PV – Pharmacovigilance, MedDRA – Medical Dictionary for Regulatory Activities

6) Documents, if any

Quality control checklists, audit reports, corrective action plans.

7) Reference, if any

ICH E2E Pharmacovigilance Planning, EU Good Pharmacovigilance Practices (GVP) Module IV.

8) SOP Version

Version 1.0