Guidelines for Pharmacovigilance Compliance Reporting

1) Purpose

The purpose of this SOP is to establish procedures for reporting pharmacovigilance compliance activities to ensure adherence to regulatory requirements and internal policies.

2) Scope

This SOP applies to the Pharmacovigilance (PV) department and personnel responsible for monitoring and reporting pharmacovigilance compliance metrics.

3) Responsibilities

The Pharmacovigilance (PV) Manager is responsible for overseeing compliance reporting activities. PV Compliance Officers and designated personnel are responsible for executing tasks outlined in this SOP.

4) Procedure

4.1 Compliance Metrics Monitoring

1. Define key performance indicators (KPIs) and metrics for pharmacovigilance compliance monitoring based on regulatory requirements and internal quality standards.
2. Regularly collect and analyze compliance data, including adherence to pharmacovigilance procedures, timely reporting obligations, and regulatory submission timelines.

4.2 Compliance Reporting

1. Generate periodic pharmacovigilance compliance reports summarizing key metrics, trends, and performance against established KPIs.
2. Review compliance reports with PV Management to assess performance, identify areas of improvement, and determine corrective actions as needed.

4.3 Non-Compliance Management

1. Investigate instances of non-compliance identified through monitoring activities, internal audits, or regulatory inspections.
2. Document non-compliance issues, root cause analysis, and corrective actions taken to address identified deficiencies.

4.4 Regulatory Reporting Obligations

1. Ensure timely and accurate reporting of pharmacovigilance compliance status to regulatory authorities as required by applicable regulations and guidelines.
2. Prepare and submit compliance reports, notifications, or responses to regulatory inquiries related to pharmacovigilance activities.

4.5 Training and Communication

1. Provide training to PV staff on pharmacovigilance compliance requirements, SOPs, and regulatory expectations.
2. Facilitate communication of compliance updates, regulatory changes, and best practices to ensure awareness and understanding among PV personnel.

4.6 Documentation and Record Keeping

1. Maintain accurate records of pharmacovigilance compliance activities, including compliance reports, audit findings, corrective actions, and training records.
2. Ensure documentation is readily accessible for internal audits, regulatory inspections, and management reviews.

4.7 Continuous Improvement

1. Periodically review and update pharmacovigilance compliance reporting procedures based on feedback, regulatory changes, and performance evaluation.
2. Implement enhancements to compliance monitoring strategies and reporting mechanisms to strengthen pharmacovigilance quality and compliance.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, KPI – Key Performance Indicator

6) Documents, if any

Compliance reports, audit findings, corrective action 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) Module I – Pharmacovigilance Systems and their Quality Systems.

8) SOP Version

Version 1.0