My Experience With MCAZ’s GVP Inspection—and What You Can Learn From It

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Last month, I participated in my second Good Vigilance Practice (GVP) inspection as a Local Qualified Person for Pharmacovigilance (LQPPV). My first in February this year was on familiar ground by Uganda’s National Drug Authority (NDA). This one was conducted by the Medicines Control Authority of Zimbabwe (MCAZ). And as we prepared for the inspection, we quickly discovered that no one on the team had prior experience with an MCAZ GVP inspection. It was a courageous dive into territory that was both unfamiliar and at the same time seemingly obvious. In this post, I document my experience as a ‘first-timer’—a reference, hopefully,  for future first-timers out there.

Pre-inspection

We received the inspection notice about three weeks before the scheduled date, although even that had to be brought forward by a few days to correspond with the availability of our subject matter experts. Fortunately, it was a remote inspection, so we did not have to deal with travel logistics.

Such short notices highlight the importance of maintaining an inspection-ready pharmacovigilance system. Yet in reality no system is ever 100% ready, and we still made minor updates to some of the documents requested ahead of the inspection.

Documents Requested

The authority requested the following documents for submission prior to the inspection:

• Pharmacovigilance System Master File (PSMF)
• CV, job description, and training records for the LQPPV and any other personnel involved in PV activities
• SOPs related to PV
• Line listing of ICSRs
• Minutes of PV-specific meetings. This was particularly challenging for us, so we prepared a note-to-file explaining how PV-related meetings are conducted. It was a key learning point to begin documenting all calls and proactively scheduling meetings to discuss PV matters specific to each country.

The requested data covered the period from the beginning of last year up to the date the inspection notice was issued.

So, what happened during the actual inspection?

Below are the key areas the authority focused on to understand our PV system:

ICSR Management

We explained in detail how ICSRs are managed – from receipt, processing in Argus (including a demo), to submission to the authority. As the LQPPV, I delegate the activity but continue to provide oversight. We shared the delegation agreement as well as training records for the team member supporting ICSR management.

Safety Database

We addressed questions and provided documented evidence regarding the safety database, including the version number, change control history, validation process, backup arrangements, and data-recovery testing.

Vendor Oversight

For vendors providing PV services to the MAH, the authority requested service agreements and the MAH’s audit history of these vendors. Our local literature-screening vendor was sampled, requiring us to provide the list of journals screened and documentation of the screening process. The authority also placed particular emphasis on the PV agreement with the local distributor and their support in digital monitoring for safety information.

Compliance Monitoring

We presented the key metrics used to evaluate PV system performance, such as ICSR quality and submission timelines. The inspection also gave us an opportunity to include validated signal communication to the authority as part of our compliance monitoring framework.

Post-inspection

We are awaiting the inspection report, which should arrive within 14 working days, after which we will submit our Corrective and Preventive Action (CAPA) plan within the same timeframe. The inspection report and CAPA will then be reviewed by the PV and Clinical Trials Committee of MCAZ, who will eventually give the official outcome.

In conclusion

I welcome inspections because having a fresh perspective review of a system provides valuable opportunities for improvement. This GVP inspection was no exception – we identified several areas for enhancement, some of which we have already begun implementing. Similar to the NDA inspection earlier this year, MCAZ asked several questions to understand how, as the LQPPV, I provide oversight of PV activities. It is an area I continue to learn and grow in.

With more health authorities across Africa rolling out GVP inspections, MAHs should begin establishing robust PV systems now rather than waiting for an inspection notice.

Beyond inspections and compliance, we must not lose sight of why we do what we do in PV. It’s easy to get caught up in performance metrics and forget the bigger picture. All stakeholders should continually ask themselves: Is what I am doing making medicines safer and building trust with patients and the public?

Additional Reading

1. Strengthening Pharmacovigilance Systems: Lessons from a GVP Inspection in Uganda
2. Reflections, operational lessons, and practical insights from a pharmacovigilance inspection: a case example of organizational strategies for medical safety readiness

Written by

Odokonyero Kennedy

Pharmacist, Global Shaper at Kampala Hub and student of Msc. Pharmaceuticals and Health Supplies Management at Makerere University. [email protected]

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