How to prepare for an ANSM pharmacovigilance inspection?
An ANSM pharmacovigilance inspection is not a “surprise audit” for teams that anticipate it properly. ANSM plans its inspections based on risk mapping, previous inspection history and safety reports related to medicinal products. It may announce an inspection in advance or conduct an unannounced inspection. In this context, preparing several months ahead can genuinely influence the outcome, as it enables companies to identify and resolve findings before they appear in the ANSM inspection report.
Feedback from Aurélia Bidant, co-founder of Alhena Consult and PV auditor, confirms this point: a pharmaceutical company that had anticipated a likely inspection several months in advance, with an on-site audit, follow-up of an action plan and a backroom in place on inspection day, benefited from a structured and documented preparation process. This enabled the company to approach the inspection with a controlled system and to limit the risk of major findings. It is therefore useful to look at how an inspection is triggered, what inspectors review and how to prepare in the months leading up to the inspection.
How is a PV inspection triggered?
A pharmacovigilance inspection may be triggered according to two main approaches. The first is part of the authorities’ routine surveillance programme. Routine inspections are organised using a risk-based approach, with an observed frequency of approximately every three years for pharmaceutical companies acting as exploitants.
The second approach is the targeted inspection. This may be triggered when a specific factor justifies a quicker or more in-depth review: a report, suspected non-compliance, a product subject to enhanced monitoring, a new therapeutic class, a significant change in the PV organisation, or a particular risk associated with one or more medicinal products. In rare cases, an external report or whistleblowing alert may also prompt ANSM to examine the situation more closely.
In terms of notice period, the most common practice remains the announced inspection. Generally, the company has approximately one month to organise itself, mobilise its teams and gather the relevant reference documents. However, this notice period is not guaranteed. Unannounced inspections also exist, particularly where the context justifies immediate intervention.
What inspectors look at
In pharmacovigilance, inspectors rely on specific reference frameworks. In France, the foundation remains the French Good Pharmacovigilance Practices, supplemented since January 2026 by the ANSM FAQ on the role of the marketing authorisation holder (MAH) and the exploitant. At European level, the GVPs (Good Pharmacovigilance Practices) provide the inspection framework, particularly for audits, case management, signal management and risk minimisation measures. Aurélia Bidant also explains that her audit checklist incorporates these reference documents, in particular the January 2026 FAQ, in order to verify whether the company meets all expected obligations.
ANSM pharmacovigilance inspections generally focus on five major areas:
- The quality management system
Inspectors review the entire quality system applied to pharmacovigilance activities: procedures, deviation management, CAPA, follow-up of findings, traceability of decisions and consistency between written documents and actual observed practices. Audit reports, whether internal or related to subcontractors and partners, as well as the effective closure of corrective measures, are among the points regularly reviewed during inspections.
Further reading: Pharmacovigilance: the new 2025 European requirements applied to quality systems - Pharmacovigilance case management
ANSM verifies compliance with applicable regulatory obligations and the robustness of the organisation in place. Inspectors look in particular at data quality, traceability of exchanges and the company’s ability to reconstruct the full history of a case, from receipt to submission to the authorities: source of information, documentation, date of entry, validations and associated evidence. - Signal management and benefit-risk monitoring
The ANSM FAQ of January 2026 recalls that the exploitant in France must monitor pharmacovigilance data in order to identify new risks, changes in known risks or any modification of the benefit-risk balance. It also specifies that signal detection activities must be carried out at national level, with the pharmacovigilance responsible person (RPV) having visibility over the methodology used, the data analysed and the conclusions reached. - Regulatory safety activities
Inspectors check the availability and local implementation of regulatory documents and tools such as PSURs, risk management plans (RMPs) and risk minimisation measures. Documentation controlled only at headquarters level does not enable a local affiliate to demonstrate compliance during an inspection. - Training, computerised systems and archiving
French Good Pharmacovigilance Practices require initial and ongoing training for all personnel, as well as control over computerised systems, including their validation and maintenance in a validated state. Traceability of activities and archiving are also recurring points of attention. As in inspections conducted under other regulatory frameworks, ANSM pays particular attention to these structuring topics.
How to prepare for a PV inspection in 6 months
Months 1 to 2: conduct a preparatory audit aligned with current regulatory texts
The first step is to conduct a preparatory audit using a checklist built from the applicable reference frameworks: at a minimum, French Good Pharmacovigilance Practices, European GVPs and the FAQ updated in January 2026. The aim is to verify how activities actually operate, identify major and minor findings and follow up on previous inspection or audit outcomes.
This approach illustrates Aurélia Bidant’s support methodology. For example, one pharmaceutical company called on Alhena Consult several months before an anticipated inspection. Aurélia then worked on site to meet the pharmacovigilance teams, assess the practices in place and identify, together with the relevant staff, the areas for improvement and points of vigilance to be strengthened.
Months 3 to 4: implement an action plan and address priority findings
The second phase consists of implementing a structured action plan. Major findings must be addressed as a priority, particularly where they concern the PV quality system, case management, signals, regulatory documents, training or computerised systems. The implementation of corrective measures must be documented, reviewed and then re-verified.
Months 5 to 6: simulate the inspection and prepare key contributors
The final two months should be used to rehearse the inspection under conditions close to reality. This means reviewing sensitive topics, preparing interviewees, testing the availability of documents, checking access rights and organising logistics.
On inspection day: the backroom
On inspection day, the backroom acts as a coordination mechanism. In this dedicated room, responses prepared in advance are monitored and organised in real time. When the inspection has been properly anticipated, the backroom is not used to improvise, but rather to maintain consistency and facilitate the transmission of documents.
In this context, the backroom plays a central coordination role during the inspection. It makes it possible to monitor inspectors’ requests in real time, prepare consistent responses, quickly identify the expected documents and direct teams towards the relevant evidence. When this organisation is based on a preparatory audit and an action plan already implemented, the questions asked on inspection day often overlap with points previously identified, which facilitates structured responses and limits the risk of major findings. In the support provided by Alhena Consult and mentioned above, the laboratory concerned ultimately received no major or critical findings at the end of the inspection.
Conclusion
A PV inspection should not be experienced as an event passively endured. It is an exercise in control, compliance and continuous improvement that must be prepared methodically. ANSM inspectors primarily assess a functioning system: quality organisation, case management, signals, benefit-risk monitoring, training, computerised systems, archiving and supporting evidence. When a Chief Pharmaceutical Officer and their team anticipate the inspection several months in advance, in particular through a preparatory audit tailored to their organisation, they approach the inspection with a system that has already been reviewed, consolidated and better documented.
Sources
ANSM: Inspecting products and practices
ANSM: Good Pharmacovigilance Practices
EMA: GVP Module III – Pharmacovigilance inspections
ANSM: PV inspection planning document, with a frequency of 2 to 3 years depending on risk
ANSM: Inspection follow-up: administrative measures
