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:
- Global pharmacovigilance systems/processes
- Company affiliates such as country office, local operating company and marketing company
- 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.