Good Vigilance Practice Audits

  • Full pharmacovigilance system audit
  • Audits of specific PV activities to check effectiveness of the process and compliance with GVP modules
  • Product-related audits focused on product-related PV issues, including product-specific activities and documentation
  • Audits of vendors, partners and third-party service providers to ensure smooth conduct of business within your company and third party
  • Due-diligence audits, vendor qualification audits and gap analysis to identify and assess consequences and likelihood of the regulatory risks
  • Pre-authorisation audits conducted with the intent of examining the existing or proposed PV system as has been described by the applicant in support of the MA application
  • Pre-inspection audits to make sure your system is fully compliant with the latest regulatory requirements
  • Corrective and Preventive Actions (CAPA)
    • Assisting in development and monitoring of CAPA
    • Effectiveness check of CAPA