Many Pharmacovigilance and Quality personnel have approached me in the last few years, requesting a Pharmacovigilance Audit Checklist. I also used to be happy to share the version I had prepared in 2012 for my first audit assignment in the European Union. Some of the requestors reverted, stating that the checklist served the purpose, and some of them even admitted that they followed the same sequence; they did not deviate from this checklist.

The Million Dollar question – Audit checklists are helpful or not?

For those who are not aware, the checklist originated in the Aviation industry. Four checklists were developed for takeoff, flight, before landing, and after landing. All pilots were taught how to use the checklist as part of their regular flight training. It may be acceptable for checklists to be used in such cases, where it is a matter of life and death.

However, one needs to be cautious about using the checklist during a Pharmacovigilance; perhaps it may be your last audit assignment! Whenever we have a ready-made tool, we may invariably rely on the same and prefer not to deviate from the same.  This is a normal human tendency. However, one should not forget that the auditor’s primary role is to identify gaps in the system. Relying entirely on a checklist may result in superficial findings only, which may impact your credibility as an auditor.  The reverse may also be true. At times, the auditees may assess their compliance against an audit checklist, which may give a false perception or a feel-good factor that everything is under control.

How not to use the Pharmacovigilance Audit Checklist

For a new Pharmacovigilance auditor or someone who has recently transitioned into this role, one can expect some hesitancy when not escorted by a Subject Matter Expert. These are the most likely situations where one may rely entirely on the Pharmacovigilance Audit Checklist. The auditor may get carried away so much that they may follow the same sequence and not deviate from the bullet points. The greatest challenge is when they miss out on going deep into certain gap areas. Such a situation may be critical, as they may miss out on the crucial gap areas.

Best way to use a Pharmacovigilance Audit Checklist

An audit checklist should be used only as a guidance document. One may refer to the same before initiating the audit or during the close of every audit day.  Another relevant strategy may be to have a brief list consisting of the bullet points of the significant areas, depending on the scope of the audit.

To conclude, having a Pharmacovigilance Audit Checklist during an audit may act as a double-edged sword. The best strategy may be to refer to it only if required.