The Pharmacovigilance System Master File (PSMF) stands as a crucial document in the realm of Good Pharmacovigilance Practice (GVP). It has been a cornerstone of the guidelines put forth by the European Medicines Agency back in 2012. Regular ad-hoc reviews of the PSMF are a common practice, particularly during audits or due diligence processes. It is essential to stay informed and ensure compliance with these essential regulatory requirements.

 A PSMF is one of the common Audit or Inspection document pre-requests. During inspection essential to share the main body of the PSMF along with the annexes. However, during the due diligence process, the company may choose not to share the annexes. If the data is presented correctly, the PSMF can expose the issues with the pharmacovigilance system. Thus, there is an opportunity for an extensive review of the pharmacovigilance system just by looking at a single document. The auditor or the inspector can then decide on the areas to focus on, and even create an agenda for the audit or inspection.

PSMF-related findings are possible during any kind of pharmacovigilance audit. Don’t be surprised if an auditee reverts that it does not have a PSMF. They may have a PSMF for some other country or region or absolutely none. If available, then the PSMF may have outdated information. This may be attributed to the lack of resources to maintain the PSMF, or infrequent updates. Many companies update a PSMF only if there is a request before an audit or inspection. Companies may provide incorrect information which may be unverified or even irrelevant. At times, you may even come across an incomplete PSMF.

It is essential that the QPPV has real-time access to the PSMF. However, there are situations where the QPPV was involved in the preparation of the initial version of the PSMF but does not continue to have access to the same. This is more common with the companies maintaining electronic versions of the PSMF, or if the QPPV is a contracted one.

The QPPV might not have oversight over the PSMF management process, especially with the source of information to be included as well as the periodic updates to the same.

Main body Vs Annexes

The annexes are expected to be in-line with the main body of the PSMF. If they are not, then this constitutes to be a finding. There is certain information that is mandatory to be included in the main body of the PSMF. If anything is missed, then a finding is guaranteed.

With regards to the annexes, the second annex (Annex B) is most likely to be incomplete. The data may not be inline with the information in the other annexes or even the main body of the PSMF.  The logbook (Annex I) is one of the most underestimated section that companies choose to keep as succinct as possible. It is expected that all the changes in the previous versions are adequately represented in the logbook. However, companies deliberately or unintentionally leave it incomplete.

Preventing a PSMF-related finding

1. Creating a standard operating procedure (SOP) for managing the PSMF updates, defining the frequency of updates, and the sources of information from the defined stakeholders
2. Including accurate information and avoiding unnecessary data
3. Avoid hiding any information
4. Periodic reconciliation of information available in the PSMF

Besides, companies decide to automate the PSMF process so that they can manage this activity with minimum resources. However, it is essential that the system is adequately validated, and the metadata is accurately captured. In the end, a quality check is essential to ensure that the information is adequately represented in the PSMF.