PHARMACEUTICAL SAFETY SURVEILLANCE
Is your organization required by law to operate a pharmacovigilance system and have it routinely audited? If so, DQS is the perfect partner to perform your system audits.
DQS is a partner of the German Medicines Manufacturers’ Association (BAH), the industry body that has defined the audit requirements for these systems. However, DQS also considers applicable regulations and your organization’s situation in its audit.
The audit requirements for pharmacovigilance systems were developed by the German Medicines Manufacturers’ Association (BAH) with experts from BAH member companies. They consider relevant regulations as well as the situation at small and medium-sized enterprises. System audits primarily aim to review the effectiveness of your pharmacovigilance system and detect weaknesses and opportunities for optimization. Being a BAH partner and an impartial third party, we can conduct system audits at your organization and help you meet your legal obligation to have your pharmacovigilance system periodically audited.
First, we thoroughly check and appraise your pharmacovigilance system master file (PSMF) to determine whether a system audit can be performed. The audit is performed onsite under the supervision of two auditors based on random samples. If you meet all the BAH criteria, you receive a three-year certificate documenting your compliance. In the next two years, you prepare status reports documenting things such as changes to your pharmacovigilance system. We review these reports as well. After three years, we conduct another complete system audit.