Guidelines for Pharmacovigilance Compliance
1) Purpose
The purpose of this SOP is to outline the policies and procedures for ensuring compliance with pharmacovigilance regulations and guidelines to ensure patient safety and regulatory adherence.
2) Scope
This SOP applies to all employees involved in pharmacovigilance activities, including the collection, evaluation, and reporting of adverse events and other safety information.
3) Responsibilities
The Pharmacovigilance (PV) team, Quality Assurance (QA) department, and all relevant staff are responsible for adhering to this compliance policy. The PV team is responsible for monitoring compliance and reporting any deviations.
4) Procedure
4.1 Policy Adherence
- All employees must familiarize themselves with current pharmacovigilance regulations and guidelines relevant to their roles.
- Regular training sessions must be conducted to ensure continuous compliance with pharmacovigilance standards.
- Compliance with pharmacovigilance policies must be documented and reviewed periodically.
4.2 Monitoring and Auditing
- Conduct regular internal audits to assess compliance with pharmacovigilance procedures.
- Document findings and corrective actions from audits in a timely manner.
- Implement necessary changes based on audit results to improve compliance.
4.3 Reporting and Documentation
- Ensure all adverse events are reported in accordance with regulatory requirements.
- Maintain accurate and up-to-date records of all pharmacovigilance activities.
- Submit periodic compliance reports to regulatory authorities as required.
4.4 Continuous Improvement
- Regularly review and update pharmacovigilance policies and procedures to reflect new regulations and best practices.
- Encourage feedback from staff to identify areas for improvement in pharmacovigilance practices.
- Implement changes promptly to enhance compliance and patient safety.
5) Abbreviations, if any
Pv – Pharmacovigilance
6) Documents, if any
Pharmacovigilance training records, audit reports, compliance reports.
7) Reference, if any
Relevant regulatory guidelines such as ICH E2E Pharmacovigilance Planning, FDA guidelines, EMA guidelines.
8) SOP Version
Version 1.0
