FAQ Pharmacovigilance-Inspections (GVP, Good Pharmacovigilance Practices)

Swissmedic has been conducting GVP inspections in Switzerland since the start of 2013. Before then, pharmacovigilance (PV) systems were reviewed in the course of GCP (Good Clinical Practice) inspections.

The main objective is to verify whether the PV systems of pharmaceutical companies (or contract research organisations/research institutes) conform to legal requirements and GVP recommendations for both authorised medicinal products and clinical trials.

Inspections are usually routine in nature, but can also be triggered by the inadequate quality of Individual Case Safety Reports or relevant findings from earlier inspections, for example.

Last updated on: 02.09.2015

GVP inspections are usually carried out by 1-2 inspectors from the CT (Clinical Trials) department, unit GCP/GVP (Good Clinical Practice/Good Vigilance Practice) inspectorate, in cooperation with 1-2 experts from the Safety of Medicines department. The inspection process is divided into three phases:

Preparation: Notification of the inspection 4-6 weeks in advance, request for documents, drafting of the provisional agenda, which is then finalised in consultation with the institution to be inspected.

Implementation: The inspection lasts 1-2 days: Opening – presentations, interviews, document review – conclusion, with an explanation of the key findings (without classification).

Inspection report: The inspection report is sent after about four weeks, after which the inspected institution prepares its CAPA (Corrective And Preventive Actions) plan.

Inspections are conducted in German, French or English.

Last updated on: 22.06.2020

The inspection team looks at the following systems, processes and documents in particular:

• Organisation and responsibilities of the medical/pharmacovigilance department
• Management of the quality system
• Interfaces with other departments
• Pharmacovigilance database and reporting systems (including reporting time limits)
• Individual Case Safety Reports from spontaneous reports and clinical trials
• Signal detection and risk management incl. risk-minimising measures
• Training documents for Health Care Professionals and patients
• Operating procedures
• Contracts with investigators, research institutes and other business partners
• Personal folders and training documents for the company's employees.

Last updated on: 02.09.2015

In accordance with EMA (European Medicines Agency) standards, findings are classified as critical, major or minor depending on the seriousness in each case. The findings are referenced on the basis of laws and recognised guidelines and directives. The report also includes comments, which usually contain notes for the inspected institution.

Last updated on: 02.09.2015

The findings primarily concern inspected institution's organisation, quality system, Individual Case Safety Reports and risk management:

• No clear description of functions and responsibilities
• Curricula vitae and job descriptions missing, not personalised or updated
• Training courses not taken or not documented
• Unclear or contradictory process descriptions, out-of-date operating procedures
• Individual Case Safety Reports of inadequate quality, late reporting to Swissmedic
• Medical assessment in ICSRs (Individual Case Safety Reports) missing or inadequate (information on awareness – causality – need for risk-minimising measures)
• Follow-up information on ICSRs not collected or collection delayed
• Information on signals and safety-related measures in other countries not proactively forwarded to Swissmedic
• Risk-minimising measures promised in the RMP (Risk Management Plan) not implemented in Switzerland.

Last updated on: 02.09.2015

The overall assessment is all around positive. GVP inspections have established themselves as an important tool for improving quality, a conclusion that is also supported by the inspected institutions themselves. They also improve communication and mutual understanding when differing viewpoints and procedures arise. They make a material contribution to the identification of existing shortcomings and provide the inspected companies/institutions with arguments to persuade decision makers of the need to implement the necessary changes.

Swissmedic will continue the successful course it has adopted by conducting approx. 8–10 GVP inspections a year in future.

Last updated on: 22.06.2020