Pharmacovigilance certification

Safety monitoring of medicinal products

Is your company required by law to operate a pharmacovigilance system and have it audited regularly? Then DQS is the right address for conducting system audits. DQS is a partner of the German Association of Pharmaceutical Manufacturers (BAH, short for "Bundesverband der Arzneimittel-Hersteller e. V."), which has formulated requirements for auditing such systems. The applicable regulations as well as the company's situation are equally taken into account.

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?

The catalog of requirements for system audits of pharmacovigilance systems was developed by the BAH with experts from BAH member companies. It is based both on the relevant regulations and on the situation in medium-sized companies. The primary objective of the system audits is to take stock of the performance of your pharmacovigilance system and to identify weaknesses and potential for optimization.

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.

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Is there an obligation to conduct system audits of the pharmacovigilance system?

In Germany, there is a legal obligation for companies to regularly audit pharmacovigilance-relevant partners (inside and outside the company). With the 2nd AMG Amendment Act, this requirement was incorporated into the AMG (Section 63b (2) AMG). Details on this obligation can be found in various modules of the Good Pharmacovigilance Practice-Guideline, especially in Module IV "Audit".

Do I have to go through the complete assessment process?

No, you can proceed step by step. For example, it is possible to commission only the comprehensive audit and assessment of the pharmacovigilance system master file (PSMF). This will tell you if there are any deficiencies already apparent in the PSMF. You can then decide whether to have the actual audit performed immediately or at a later date when you have corrected the deficiencies.

Optionally, you can also commission a pre-audit to have the pharmacovigilance system checked in advance on site. However, only the regular system audit leads to the granting of a certificate, if applicable.

Who is the German Association of Pharmaceutical Manufacturers? (BAH)?

The BAH represents the interests of around 470 member companies from the pharmaceutical industry. These include pharmaceutical manufacturers as well as contract research institutes, law firms, publishers, agencies, and market and opinion research institutes in the healthcare sector. The BAH is thus by far the association with the largest number of members in the pharmaceutical industry in the Federal Republic of Germany.

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.

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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.