Pharmacovigilance inspections -veterinary
Published:
Changes
The purpose of a pharmacovigilance inspection is to ensure that PhV procedures are implemented in accordance with current regulations and that the PhV system operates in compliance with the authorities' requirements for the relevant product(s).
Types of inspections
Most inspections are routine inspections. The companies are selected according to a risk-based approach. Potential candidates include all marketing authorization holders for veterinary medicinal products as well as companies in Norway performing PhV activities on their behalf.
Inspections are conducted as national inspections or on behalf of the European Medicines Agency (EMA) in cases where NOMA is the Supervisory Authority.
Announcement
Inspections will be notified to the QPPV/local responsible person via phone approximately 4 weeks in advance, followed by a written announcement via email. The notification includes the time and place of the inspection, a preliminary agenda, and a list of documents to be submitted prior to the inspection. Documentation requested ahead of an inspection includes e.g. the Pharmacovigilance System Master File (PSMF), PhV procedures and work instructions, as well as an overview of adverse reaction reports for a specified time period. A detailed agenda will be sent approximately one week before the inspection.
Conduct
A national inspection usually takes 2-3 days, while an EMA inspection lasts approximately 5 days. The inspection starts with an opening meeting where both parties are introduced, followed by interviews and document reviews.
Typical areas covered include: handling of adverse reaction reports, signal detection and handling of variations. The inspection is finalized with a closing meeting, where the inspectors' observations are presented.
Report
Within 30 days after the last day of inspection, a report will be issued classifying the observations as deviations or recommendations. All deviations include a reference to relevant legislation and are graded as either critical, major, or other deviations. The inspected parties respond to the report by submitting a corrective and preventive action plan. For each deviation in the report, corrective and preventive measures and deadlines for implementation must be specified. Once the measures are implemented, documentation confirming their execution must be submitted. When all deviations are resolved, the inspection is closed.