Pharmacovigilance auditing


Why is good auditing practice so vital?

Pharmacovigilance audits help identify and resolve compliance issues in a cost-effective, planned manner, before the regulatory inspectors impose punitive and costly demands on companies to carry out urgent remedial actions.

Pharmacovigilance audits fall into 3 groups:

  1. Global pharmacovigilance systems/processes
  2. Company affiliates such as country office, local operating company and marketing company
  3. Marketing (licensing) partners

Risk based audits

Regulations have increased in recent years, but by using a risk based strategy to audits, companies can identify problems at different stages of the drug safety process and achieve compliance.

Pharmacovigilance audits include:

  • Auditor reviews quality management system currently used to collect, code and process data for independent case study reports.
  • Examines qualifications of staff performing pharmacovigilance and the roles and responsibilities of the European Qualified Person for pharmacovigilance are also examined.
  • Assess whether database used to store information on adverse events is compliant with current regulations.
  • Safety surveillance systems review and strategies for detecting and mitigating risk and the procedures.
  • Safety literature review and disaster recovery and business continuity plans.
  • Assess processes and procedures for generating and reviewing reports and including adverse events.
  • Review procedures in call centre and other departments for handling safety complaints, adverse events, and urgent safety issues.

Review of third party procedures and contractual agreements.

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