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PV Audit by Quality: Friends or Foes?

Posted on March 9th, 2017 by in Pharmacovigilance


One of the major ways to measure the health of a Pharmacovigilance (PV) organization is to organize regular audits by experienced Quality Assurance (QA) auditors. During such audits, how open should PV be with the auditors about compliance weaknesses not yet identified by the QA auditors? Should the QA audit plan focus on mimicking real life inspections during their audits or allow some flexibility? Let us consider a few key points here.

What are the benefits of a mock inspection?

A mock inspection is the best opportunity to verify the logistics and the practices in place and ascertain how well the PV function (and other functions contributing to PV activities) will behave during a real, unannounced, Health Authority inspection. Like a good stage drama, unity of action, time and place are critical to make this exercise the most informative; only a few formalized time-off periods during the mock inspection will be allowed in order to mimic the real life pressure of an actual inspection, while allowing for on the spot debriefing opportunities to course-correct the exercise as needed. The main benefit from running a PV audit like a mock inspection is to ensure the organization is operationally ready: rooms and technical settings, documents generation, the ability to provide the right experts for the interviews, and the ability for the interviewees to provide the correct information in a concise way without drifting into out of scope topics.

However, mock inspections may not help the QA auditors find all potential areas of non compliance. Mock inspections lack the openness and dialogue that should allow interviewees to volunteer broader compliance risks for the greater good of the company.

What are the benefits of a PV Audit?

A PV audit will take place in a very different setting. Previous regular interactions with the QA group should allow for more open discussions, with a level of stress lower than the mock inspection environment. In this context, it is possible for PV to share more operational and strategic perspectives on how the company could reach a higher compliance status. QA will provide expert guidance to remediate to and prevent compliance deviations. The audit report can even be used as a vehicle to raise senior leadership awareness on opportunities to become a more compliant entity. So, in this beautiful world, should PV be totally open to the auditors to get their advice and support? Well, this is not that easy.

What are the best options?

Both audits and mock inspections are essential exercises. QA should be clear on the on the nature of the exercise taking place, as they measure different parameters and behaviors.

Should PV be willing to be vulnerable and be judged by its peers in its efforts to improve its processes, and if so, how much?  Sometimes PV functions want to hold their cards to their chest regarding potential compliance issues which are being remediated. In many organizations with dysfunctional cultures, judgments abound and no one wants to become exposed to others’ criticism. In other companies where no one wants to hear about problems, exposing potential compliance risks may lead to a negative perception of the PV performance, with might in turn influence how individuals’ performance is viewed. These behaviors and culture will never lead any organization closer to its desired compliance level.  Hiding potential risks is the always the worst possible option. Openness is always a much better alternative.

Sharing risks and areas of concerns with the auditors will reinforce a true partnership with a knowledgeable and empathetic QA group, which should be helping more than judging. It will create a constructive atmosphere focused on process improvement, and will bring the best minds around the table to find solutions to current or potential compliance deviations. Recognizing QA as a friendly partner is key for PV to reach its compliance objectives and make the very best of the PV mock inspections and audit exercises. It will help the whole organization to elevate its compliance culture and its understanding of pharmacovigilance needs. In conclusion, friends, not foes.

JP Clement

Elsevier recommends:

As part of planning pharmacovigilance, every pharmaceutical company must have a solid strategy to screen scientific literature and conference proceedings for adverse events involving their products. Missing an adverse event could lead to serious responses from regulatory authorities.  Do you have a thorough strategy to remain compliant and mitigate risk?   Download our free whitepaper:  Minimize your risk in pharmacovigilance.


All opinions shared in this post are the author’s own.

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