Is your Quality Management System effective in supporting the pharmacovigilance processes and activities? Are you ready for your next inspection?

Veterinary pharmacovigilance systems, a new process to monitor 

With the introduction of the Veterinary Good Vigilance Practice (VGVP), the Quality Management System (QMS) has become the process that the Marketing Authorization Holder must put in place in order to comply with the new guidelines. In order to be effective, the QMS must be constantly monitored and reviewed in order to verify that it is working as expected and to define actions for continuous improvement.  

Audits as a system evaluation tool 

Scheduled audits, or risk assessments, should be performed to define the audit frequency (audit plan) at strategic, tactical and operational levels. These risk assessments are required in order to cover all the pharmacovigilance activities and involved third parties, and the audits of pharmacovigilance systems must verify conformity with the policies, processes and procedures of the QMS. Included in the audit plans are also all of the third parties that carry out pharmacovigilance activities in whole or in part, as well as the third parties that have a commercial relationship with pharmacovigilance responsibility, such as the nominated Local Representative.  

Mock inspections to ensure readiness 

It is a good idea to put in place mock inspections to periodically test your system. This will also enable you to maintain a high level of attention by all involved personnel while evaluating the effectiveness of the entire system. 

Key Performance Indicators as system evaluation tools

A well-defined KPI is simple to understand, easy to measure and interpret, is reproducible and sensitive to problem detection. KPIs help you identify strengths, weaknesses, achievements, growth and impacts on the system. You can start monitoring the timeline for submission and the quality of your reports, and you can also evaluate your quality system performance related to pharmacovigilance activities. And you can use this information to update and improve your processes and guarantee correct management for the safety of your product to ensure animal health. 

CAPA for improvement  

A good Corrective and Preventive Action (CAPA) plan for your audits’ observations and KPI review findings will also allow your Pharmacovigilance System and all third parties to continuously improve performance; monitoring and assessing the effectiveness of the actions planned and the associated changes are fundamental to ensuring the system is kept under control.