Guidelines for Pharmacovigilance Compliance Monitoring Plan
1) Purpose
The purpose of this SOP is to outline procedures for monitoring pharmacovigilance activities to ensure compliance with regulatory requirements and internal standards.
2) Scope
This SOP applies to pharmacovigilance personnel responsible for conducting compliance monitoring activities within the organization.
3) Responsibilities
The Pharmacovigilance (PV) Manager is responsible for overseeing compliance monitoring activities. PV staff involved in monitoring are responsible for adhering to this SOP.
4) Procedure
4.1 Development of Compliance Monitoring Plan
- Define the scope and objectives of the compliance monitoring plan, considering regulatory requirements and organizational priorities.
- Identify key pharmacovigilance activities and processes to be monitored, including case processing, reporting timelines, and quality assurance checks.
4.2 Monitoring Activities
- Establish monitoring procedures and frequency for each pharmacovigilance activity identified in the plan.
- Conduct regular reviews and audits to assess compliance with standard operating procedures (SOPs), regulatory guidelines, and internal policies.
4.3 Data Collection and Analysis
- Collect data on pharmacovigilance activities through audits, reviews, and inspections.
- Analyze collected data to identify trends, issues, and areas for improvement in pharmacovigilance compliance.
4.4 Reporting and Communication
- Prepare compliance monitoring reports summarizing findings, including observations, deviations, and corrective actions taken.
- Communicate monitoring results to relevant stakeholders, including PV team members, management, and regulatory authorities as required.
4.5 Corrective and Preventive Actions (CAPA)
- Develop CAPA plans to address identified non-compliance issues and improve pharmacovigilance processes.
- Implement corrective actions in a timely manner and monitor their effectiveness in preventing recurrence of non-compliance.
4.6 Documentation and Record Keeping
- Maintain comprehensive records of compliance monitoring activities, including monitoring plans, audit reports, CAPA plans, and communication logs.
- Ensure that all documentation is stored securely and is readily accessible for inspection and review.
4.7 Training and Awareness
- Provide training to PV staff on the importance of compliance monitoring and the procedures outlined in this SOP.
- Offer continuous education and updates on pharmacovigilance regulations, guidelines, and best practices.
4.8 Continuous Improvement
- Regularly review and update the compliance monitoring plan based on feedback, audit findings, and regulatory changes.
- Implement improvements to enhance the effectiveness and efficiency of pharmacovigilance compliance monitoring activities.
5) Abbreviations, if any
PV – Pharmacovigilance, SOP – Standard Operating Procedure, CAPA – Corrective and Preventive Actions
6) Documents, if any
Compliance monitoring plan, audit reports, CAPA plans, training materials.
7) Reference, if any
ICH Guideline for Good Clinical Practice, FDA Guidance for Industry – Pharmacovigilance Responsibilities of Marketing Authorization Holders (MAHs), EU Guidelines on Good Pharmacovigilance Practices (GVP).
8) SOP Version
Version 1.0
