Pharmacovigilance legislation established a legal requirement for MAHs to perform audits of their pharmacovigilance systems, including risk-based audits of their quality systems.
According to GVP Module I, an audit is a systematic, disciplined, independent and documented process for obtaining evidence and evaluating the evidence objectively to determine the extent to which the audit criteria are fulfilled, contributing to the improvement of risk management, control and governance processes.
Pharmacovigilance audit activities should verify, by examination and evaluation of objective evidence, the appropriateness and effectiveness of the implementation and operation of a pharmacovigilance system, including its quality system for pharmacovigilance activities.
You can outsource GVP audits to SciencePharma, who has already performed hundreds of audits for both local and foreign Clients.
Our GVP audits services include among others:
What makes us the best? Being a PhV provider for almost 2 decades, we are systematically audited and inspected. This allows us to gain experience, be up to date with all GVP requirements and ensure that we are in constant audit readiness.