Guidelines for Pharmacovigilance Quality Management

1) Purpose

The purpose of this SOP is to outline the procedures for establishing, maintaining, and continuously improving the Pharmacovigilance Quality Management System (QMS) to ensure compliance with regulatory requirements and quality standards.

2) Scope

This SOP applies to all personnel involved in the pharmacovigilance activities and the management of the QMS within the pharmacovigilance department.

3) Responsibilities

The Quality Assurance (QA) department is responsible for overseeing the QMS. All pharmacovigilance staff are responsible for adhering to the quality standards and procedures defined in the QMS.

4) Procedure

4.1 Establishing the QMS

1. Define the quality objectives and scope of the QMS.
2. Develop and document quality policies, procedures, and processes.
3. Assign roles and responsibilities for maintaining the QMS.

4.2 Implementing the QMS

1. Train all relevant staff on the QMS procedures and their responsibilities.
2. Ensure that all pharmacovigilance activities are conducted in accordance with the QMS.
3. Monitor the implementation of the QMS to ensure compliance and effectiveness.

4.3 Maintaining the QMS

1. Conduct regular internal audits to assess the performance of the QMS.
2. Document audit findings and implement corrective actions where necessary.
3. Review and update QMS documentation periodically to reflect changes in regulations, guidelines, or company procedures.

4.4 Continuous Improvement

1. Encourage staff to provide feedback on the QMS and suggest improvements.
2. Analyze quality metrics and performance data to identify areas for improvement.
3. Implement changes to the QMS based on audit results, feedback, and performance data.

4.5 Documentation and Record Keeping

1. Maintain accurate and up-to-date records of all QMS activities, including audits, training, and corrective actions.
2. Ensure that all QMS documentation is securely stored and easily accessible.
3. Retain QMS records in accordance with the company’s document retention policy.

5) Abbreviations, if any

QMS – Quality Management System
QA – Quality Assurance

6) Documents, if any

Quality policies, procedures, audit reports, training records, corrective action logs.

7) Reference, if any

ICH E6 (R2) Good Clinical Practice, EU Good Pharmacovigilance Practices (GVP) Module I.

8) SOP Version

Version 1.0