Regulatory GVP Compliance Auditing

PharmaConsult will carry out an Audit of the Pharmacovigilance Management system and provide observations on the compliance with Good Vigilance Practice Regulations to prepare organisations for a Regulatory Authority Inspection.

Good Pharmacovigilance Practice compliance Audits comprise of:

  • Collecting and managing data on the safety of medicines
  • Looking at the data to detect ’signals’ (any new or changing safety issue)
  • Evaluating the data and making decisions with regard to safety issues
  • Acting to protect public health (including regulatory action)
  • Communicating with stakeholders
  • Audit, both of the outcomes of action taken and of the key processes involved.