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