An inspection tests what was done, not only what was written.
A pharmacovigilance system can have complete procedures and still struggle during an inspection. Inspectors begin with the documents, but they do not stop there. They select a case, a report or a decision and follow the records behind it: where the information came from, how it was assessed, when it was submitted and who reviewed it at each step.
This article sets out the areas an inspector is likely to examine, and the questions behind each one. It uses the structure of EU Good Pharmacovigilance Practices (GVP) as its reference, including Module III on pharmacovigilance inspections. Requirements and inspection practice differ between authorities, so confirm the details with the authority that regulates your products.
1. The system as described, and the system as it runs
Inspectors usually start with how the pharmacovigilance system is described: the pharmacovigilance system master file (PSMF), the person responsible for pharmacovigilance, and the roles and responsibilities around them.
The question behind this area is simple: does the description match reality? Names, deputies, locations, systems and delegated activities should be current in the master file, and the people named should be able to explain what they do.
2. Case handling and reporting timelines
Individual Case Safety Reports (ICSRs) are the area where inspectors can most easily test a process with evidence. A typical approach is to select a sample of cases and trace each from first receipt to submission.
For each case, be ready to show:
- when and from whom the information was first received, and when the reporting clock started
- how the case was entered, coded and assessed, including seriousness, causality and expectedness
- who performed medical review, and when
- how follow-up information was requested and recorded
- when the case was submitted, to whom, and how duplicates were handled
A late submission is a finding on its own. A late submission with no record of why it was late is a larger one.
3. Literature screening and signal detection records
Inspectors look for evidence that a search took place, not only that a procedure for searching exists.
For literature screening, this means the search strategy, the databases used, the frequency of screening, and a record of what was reviewed and what was decided. For signal detection, it means the methods used, the dates of each review, and the rationale behind each outcome.
A review that finds no signal still needs a record. Without one, the absence of signals cannot be distinguished from the absence of looking.
4. Periodic reports and risk management
Inspectors check that periodic benefit-risk evaluation reports (PBRER/PSUR) were submitted on time, that the data lock points are consistent with the reporting schedule, and that conclusions are supported by the data presented.
For risk management, the question is whether commitments made in the Risk Management Plan (RMP) are carried out. Where risk minimization measures (RMMs) apply, inspectors look for evidence that they were implemented and for how their effectiveness is monitored.
5. The quality system, CAPA and document control
A quality system is judged by how it behaves when something goes wrong. Inspectors read deviation records, audit reports and corrective and preventive actions (CAPA) together, looking for a clear line from finding to action.
A CAPA record should show:
- the root cause, not only the symptom
- a named owner and a due date
- the action taken
- a check that the action worked
Document control follows the same logic. Procedures should be current, approved and available to the people who use them, and superseded versions should be retained and identifiable.
6. Training and oversight of delegated activities
Training records are examined against the work performed. An inspector may select a person who processed a case and ask whether that person was trained on the relevant procedure before doing so.
Where activities are delegated to a service provider, the Marketing Authorization Holder remains responsible for them. Inspectors therefore look for a written agreement, a defined scope, and evidence of oversight: reports received, meetings held, issues escalated and resolved. An agreement alone does not show oversight.
How findings are described
In the EU, inspection findings are classified by their potential impact on the pharmacovigilance system and on the protection of public health, from minor to critical (GVP Module III). In practice, the classification depends heavily on whether a gap is isolated or systemic, and on whether the organization had already identified it.
That second point is within the organization's control. A gap that was found internally, recorded and followed through CAPA reads very differently from one that the inspector discovers first.
A practical test
Choose one ICSR submitted in the last quarter and trace it from first receipt to submission, using only the records. Then choose one CAPA and trace it from the finding to the effectiveness check.
If either trace needs someone to explain what the records do not show, that is the gap an inspector will find as well.
How Intelligate can help
Intelligate provides audit and inspection consultancy for MAHs and CROs: preparation ahead of an audit or inspection, gap analysis against the applicable standards, and support in defining and following CAPA. Our pharmacovigilance team also handles ICSR management, literature screening and signal detection, and supports the preparation and review of periodic reports and risk management documents.
To discuss your next inspection, contact us at info@intelligate-eg.com or through the contact page.