Why Is Inspection Preparation Essential?

Pharmacovigilance (PV) inspections are a core element of regulatory oversight. Deficiencies identified during inspections can result in CAPAs, regulatory warning letters, or even cessation of marketing authorisation. To avoid such consequences, a structured and proactive preparation is essential - ensuring your PV system withstands authority inspections.

Today, PV inspections are not only more frequent and complex, but also increasingly international. Authorities no longer inspect only global headquarters - local entities are equally under scrutiny.

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When the pharmacovigilance system of a Marketing Authorisation Holder (MAH) is inspected within the EU - for example by authorities such as BfArM, PEI, SUKL, or AIFA - the inspection often covers the entire EU-compliant global PV system, not just local processes. The focus lies on overall system compliance, including global procedures, interfaces, and oversight structures.

In contrast, non-EU authorities such as the SFDA or EDA typically inspect the local pharmacovigilance systems of EU-based companies operating in their territory. These inspections assess compliance with local requirements and the integration of local PV activities into the global system. In such cases, the local representative or affiliate must demonstrate that processes like local literature screening, case handling, and local PSMF/PSSF maintenance are not only compliant with national regulations, but also properly aligned with the company’s global PV system.

In countries with specific local regulatory or language requirements, local teams often need expert support - both in ensuring the quality and completeness of documentation and in navigating the inspection process itself.

One of the most demanding aspects of PV inspections is document handling. Authorities frequently issue extensive document requests. These typically cover key documents such as the PSMF or PSSF, PV agreements, training records, SOPs, deviation reports, audit documentation, and various process-related records.

To ensure completeness, traceability, and consistency under tight timelines, a structured and proactive approach is essential. With the right preparation and clear coordination, your team can approach the inspection with confidence - and stay in control throughout the whole inspection.

In line with EU GVP Module III, I support you with a clear methodology and forward planning that aligns with regulatory expectations - from preparation and document coordination to confident inspection performance.

Inspection Preparation & Support

Key Phases of a PV Inspection

1. Notification & Planning
   The inspection is announced; internal roles and responsibilities are defined.

2. Document Request & Submission
   Authorities request key documents for review (e.g., PSMF, SOPs, agreements). Timely and accurate submission is essential.

3. Inspection Execution
   Includes interviews, system walkthroughs, and document assessments.

4. Inspection Report & CAPA Management
   The authority provides a report with findings. CAPAs must be developed, implemented, and tracked.

Navigating PV Inspections Successfully