Good Pharmacovigilance Practice Audits, Gap Analyses and Inspections
Good Pharmacovigilance Practice guidance in the majority of jurisdictions requires the pharmaceutical industry to have a robust self-inspection/audit programme based on a risk assessment of their pharmacovigilance system. The audit programme is expected to include in-house activities, as well as those of vendors, commercial partners and any other stakeholders that are part of the pharmacovigilance system. Regulatory guidance requires that auditors are independent of the process being audited and qualified to conduct pharmacovigilance audits.
Additionally, the industry is seeing an increased frequency of pharmacovigilance-based inspections from regulatory agencies, with an increasing focus on pharmacovigilance Quality Management Systems.
Mapi has experienced auditors and ex-agency inspectors in their pharmacovigilance team that can support Pharmacovigilance and Quality Assurance functions with their global audit activities and regulatory inspection management. Our auditors have experience in:
- Conducting gap analyses and risk assessments of pharmacovigilance systems against global regulatory requirements;
- Conducting audits of pharmacovigilance systems, including vendors and commercial partners;
- Preparing for anticipated regulatory inspections;
- Hosting regulatory inspections;
- Assisting with pharmacovigilance system improvements following regulatory inspections and/or internal audits.