Guidelines for Pharmacovigilance Compliance Monitoring

1) Purpose

The purpose of this SOP is to outline procedures for monitoring and ensuring compliance with pharmacovigilance regulations and guidelines.

2) Scope

This SOP applies to all pharmacovigilance personnel responsible for compliance monitoring, including pharmacovigilance managers, compliance officers, and quality assurance personnel.

3) Responsibilities

The Compliance Monitoring Team is responsible for conducting regular assessments and audits to verify adherence to pharmacovigilance regulations and internal procedures. The Pharmacovigilance (PV) Manager oversees the compliance monitoring process to maintain regulatory compliance and quality standards.

4) Procedure

4.1 Compliance Assessment Planning

1. Develop a compliance assessment plan based on regulatory requirements and company policies.
2. Define objectives, scope, and methodologies for compliance assessments.
3. Allocate resources and establish timelines for assessment activities.

4.2 Documentation and Record Review

1. Review pharmacovigilance documentation, including SOPs, training records, and case files, for compliance with regulatory requirements.
2. Verify documentation completeness, accuracy, and adherence to established standards.
3. Document findings and observations from documentation reviews.

4.3 On-Site Audits and Inspections

1. Conduct on-site audits and inspections to assess operational compliance with pharmacovigilance procedures.
2. Evaluate adherence to pharmacovigilance practices, including case processing, signal detection, and reporting.
3. Generate audit reports and communicate findings to relevant stakeholders.

4.4 Performance Metrics and Key Performance Indicators (KPIs)

1. Develop and monitor performance metrics and KPIs related to pharmacovigilance compliance.
2. Track compliance trends and identify areas for improvement based on performance data.
3. Report on compliance metrics to management and stakeholders.

4.5 Corrective and Preventive Actions (CAPAs)

1. Implement CAPAs based on findings from compliance assessments, audits, and performance metrics.
2. Monitor the effectiveness of CAPAs in addressing compliance issues and preventing recurrence.
3. Document and communicate CAPA outcomes to ensure closure of compliance gaps.

4.6 Training and Development

1. Provide training to pharmacovigilance staff on compliance requirements, procedures, and best practices.
2. Support continuous professional development and competency building in pharmacovigilance compliance.
3. Ensure awareness and understanding of regulatory updates and changes among team members.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, CAPA – Corrective and Preventive Action, KPI – Key Performance Indicator

6) Documents, if any

Compliance assessment reports, audit findings, CAPA logs, performance metrics reports.

7) Reference, if any

ICH E2E Pharmacovigilance Planning, EU Good Pharmacovigilance Practices (GVP) Module II – Pharmacovigilance System Master File.

8) SOP Version

Version 1.0