Quality Control Inspection Checklist – PSMF

Confirm that the PSMF is up-to-date and accurately reflects the current pharmacovigilance system.

Verify that all relevant SOPs (Standard Operating Procedures) are included and accessible.

Check for the presence of training records for staff involved in pharmacovigilance activities.

Ensure that all relevant regulatory requirements are incorporated into the PSMF.

Review the data collection processes to ensure compliance with established protocols.

Verify that data is accurately captured and documented in the pharmacovigilance database.

Check for the implementation of data validation procedures.

Ensure that adverse event reports are processed and documented in a timely manner.

Verify that there are clear procedures for reporting adverse events to regulatory authorities.

Check for adherence to timelines for reporting serious adverse events.

Confirm that follow-up procedures are in place for obtaining additional information on reported cases.

Ensure that communication channels are established for internal and external reporting.

Review the risk management plan to ensure it is comprehensive and aligned with current practices.

Confirm that risk assessment processes are documented and regularly updated.

Verify that risk minimization strategies have been effectively implemented.

Ensure that the effectiveness of risk management activities is monitored and evaluated.

Review the results of recent internal and external audits related to pharmacovigilance.

Confirm that corrective and preventive actions (CAPAs) have been implemented for identified issues.

Check for adherence to regulatory inspection findings and recommendations.

Ensure that regular self-inspections are conducted to assess compliance.

Verify that all relevant staff members have received adequate training on pharmacovigilance practices.

Check for documentation of ongoing training and competency assessments.

Ensure that training materials are up to date and reflect current guidelines and regulations.

Confirm that new employees receive appropriate onboarding in pharmacovigilance processes.

Review mechanisms for collecting feedback on pharmacovigilance processes.

Ensure that there is a process for regularly reviewing and updating the PSMF.

Confirm that lessons learned from previous incidents are documented and utilized for improvement.

Check for the establishment of a culture that encourages reporting and transparency in safety issues.

This checklist serves as a guide to ensure compliance with GVP Module 2 and the effective management of pharmacovigilance activities.

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