Safety monitoring of medicinal products
Documented conformity of your pharmacovigilance system
Recognized proof of compliance with legal obligations
Lower costs due to the joint approach of BAH and DQS
Eeduction of multiple audits by partners
What does the pharmacovigilance certificate stand for?
Many companies are overwhelmed by the task of carrying out regular audits of their own pharmacovigilance systems as well as those of their partners. Often, they do not have sufficiently qualified auditors who are independent of the pharmacovigilance department. Therefore, in many cases, audits have to be performed by service providers.
As a partner of the BAH, we carry out these pharmacovigilance audits in your company as a neutral third party. In this way, we make it easier for you to fulfill the legal obligation to regularly audit your pharmacovigilance system.
Is there an obligation to conduct system audits of the pharmacovigilance system?
Do I have to go through the complete assessment process?
Who is the German Association of Pharmaceutical Manufacturers? (BAH)?
With this, Germany adheres to the overall EU pharmacovigilance system, subject to the European Medicines Agency (EMA), which coordinates pharmacovigilance in the EU and operates services and processes in line with EU legislation. The Agency works closely with a number of international partners, in particular:
- United States Food and Drug Administration (FDA): sharing information on drug safety issues and on anticipated regulatory action, public information and communication prior to decision-making and publication.
- World Health Organisation (WHO): communication of any measures taken regarding centrally authorised medicines that may have a bearing on public health protection in countries outside the EU.
How does a pharmacovigilance certification with DQS work?
In the first step, your pharmacovigilance system master file (PSMF) is comprehensively reviewed and assessed in order to assess whether the actual system audit can be performed. This audit is performed on-site based on random sampling and is led by two auditors (one pharmacovigilance expert and one system auditor). It usually lasts one day. If the requirements of the BAH catalog are met, you receive a certificate valid for three years as proof of compliance.
In the first and second year after the audit, DQS reviews an annual interim report prepared by the company. In the Annual Report, the company lists the innovations in the pharmacovigilance system and how any findings from the audit have been resolved.
Additional audits may be necessary in subsequent years of the audit if there are major company changes (e.g., a major acquisition or sale of the company, a change in the QPPV or step plan officer, or the pharmacovigilance database). If there are no major company changes or changes to the pharmacovigilance system, a full system audit is not performed again to renew the certificate until after the third year.