Five frequent inspection findings and the role of the QPPV

One of the complications with system oversight is that not all activities are under the control of the QPPV. If there is an update to product safety information, the QPPV’s job is fairly straightforward since this is directly under their control. 

However, a change within the summary of product characteristics (SmPC) is more complicated since this is managed by regulatory and medical affairs. The QPPV must therefore monitor whether regulatory affairs has submitted a variation. If that variation has been approved by the authority, the QPPV must then review whether the manufacturer has received the updated text in time to ensure the new package insert gets into the package in a reasonable timeframe. Ultimately, this information has to reach patients, physicians, and pharmacists, which is the responsibility of the QPPV. This is a common inspection finding, but maintaining that broader level of oversight is very difficult for the QPPV given the different stakeholders involved. 

A similar issue arises when gathering reports and side effects. Again, this is relatively straightforward with signal detection, but if the company decides to run a new patient support program in a separate system or a new social media channel, that information may not be readily available to the QPPV.  This dynamic environment raises questions about system oversight.

A frequent issue we see is with the completeness and consistency of company databases. For example, when companies bring in new product portfolios or divest of products, questions can arise over data completeness and consistency. 

Regulatory authorities expect companies to fulfil quality standards with their databases and ensure information is accessible and retrievable after the migration of new product data.² This expectation has tightened as inspectors have gained a better understanding of systems and databases, enabling them to review, investigate, and challenge how safety databases have been set up. 

While this is not specifically a QPPV finding, the QPPV is the pharmacovigilance system and process owner, so inspectors are challenging them to show how they are maintaining the system to ensure it is fit for purpose. Where companies have automated reporting systems, inspectors are looking to see that the system is doing what is expected and that there is proper oversight to ensure no submissions are overlooked. 

A third finding we see is failure to have full oversight of PV processes on a global level. It is up to the QPPV to make sure the key PV processes are properly performed, measured, and controlled. The QPPV should conduct regular exchange and communication with all stakeholders, and adopt rigorous risk management of the products and ensure oversight of the system.  

Note that risk management for products may include educational material or other instruments to support safe use. The QPPV should also have oversight of implementation metrics, and monitor effectiveness of these studies. It’s important to keep in mind that tools that work in one health care system may not be suitable in others. And as these materials are implemented in complex local settings with national authorities, it can be especially challenging to maintain oversight for the complete system – requiring additional attention from the QPPV.

The PSMF is very closely linked to the QPPV role and is core to the overall PV processes.³ A common finding we see is that the PSMF is outdated. New products may not have been added to the system, while old products have yet to be removed. Keeping this information up to date is a challenge for almost every company. 

While companies often do use technical solutions to manage and maintain the PSMF, there is still a need for oversight to ensure information is kept up to date, including information from non-PV functions. This requires constant management, ongoing communication, and a clear structure or standard operating procedures throughout the company.