Many life sciences companies are still struggling with pharmacovigilance audits and inspections eight years after EU legislation came into force. Vanessa Fachada Oliveira, pharmacovigilance manager & EU QPPV at Arriello, highlights key areas of focus for marketing authorisation holders to achieve an effective audit of their pharmacovigilance systems.
Inspection
Regulating authorities need to be confident that standards relating to pharmacovigilance (PV) activities are being upheld. It is vital that pharmaceutical organisations can provide evidence of strong standard operating procedures on demand. Yet, although eight years have elapsed since EU legislation on PV came into force, a majority of companies are still struggling to fulfil their obligations, potentially causing marketing authorisation holders (MAHs) to fail inspections, incur fines and see products withdrawn from markets.
One of the reasons for common failings in PV process documentation is that the EU has not set out clear guidelines about how or where companies should go about this. Here are some of the problems this can cause and what can be done to rectify the situation: