Quality Control Checklist – Pharmacovigilance System Master File (PSMF)

Verify the document version is current and includes the date of the last update.

Check that the PSMF is appropriately signed and approved by authorized personnel.

Ensure the contact information for the Responsible Person is accurate and up-to-date.

Confirm that the PSMF includes a clear description of the pharmacovigilance system in place.

Evaluate the adequacy of the organizational structure related to pharmacovigilance.

Review the roles and responsibilities of personnel involved in pharmacovigilance activities.

Assess the methods used for data collection, processing, and storage.

Ensure compliance with data protection regulations and confidentiality agreements.

Verify the existence of a data management plan that outlines data handling procedures.

Check the procedures for the collection and reporting of adverse drug reactions (ADRs).

Ensure that timelines for reporting serious ADRs are clearly defined and adhered to.

Confirm that there is a system in place for follow-up on reported ADRs.

Review the risk management plans (RMPs) in place for marketed products.

Verify that the PSMF outlines methods for signal detection and evaluation.

Check for documentation of risk communication strategies to stakeholders.

Ensure that training records for personnel involved in pharmacovigilance are maintained and up to date.

Confirm that training programs include current regulations and company policies.

Review compliance with internal standard operating procedures (SOPs) related to pharmacovigilance.

Verify that there is a quality assurance process in place for pharmacovigilance activities.

Check for audit trails and documentation of audits conducted on the pharmacovigilance system.

Ensure that corrective and preventive actions (CAPA) are documented and followed up.

Confirm that the PSMF adheres to local and international regulatory requirements.

Check for documentation of communications with regulatory authorities.

Review the process for updates to the PSMF in response to regulatory changes.

Ensure that there is a process for regular review and update of the PSMF.

Check for feedback mechanisms to identify areas for improvement within the pharmacovigilance system.

Verify that lessons learned from adverse events are integrated into the pharmacovigilance processes.

Confirm that all relevant documentation is maintained in an organized manner.

Check for retention policies regarding pharmacovigilance records.

Ensure that records are readily accessible for audits and inspections.

This checklist serves as a guide to ensure the quality and compliance of the Pharmacovigilance System Master File (PSMF).