Pharmacovigilance Audits

The regular auditing of a company's own pharmacovigilance systems – including subsidiaries – as well as of the commissioned partners – including distributors and pharmacovigilance service providers – required, among others, in the German Medicinal Products Act (AMG) and in Module IV “Audit” of the Good Pharmacovigilance Practices Guideline, represents a growing challenge for many MAHs.

This is precisely where we come in with our many years of pharmacovigilance expertise, and we have developed a specific audit programme that keeps the regulatory requirements as well as the needs of the medium-sized pharmaceutical industry equally in view.

As a building block of your company's own quality management, in preparation for a regulatory inspection, as an internal training measure or as a consulting measure on the occasion of regulatory changes, our qualified auditors conduct pharmacovigilance-specific audits Europe-wide. In doing so, a systematic examination and evaluation of the pharmacovigilance system of your company and/or your commissioned partner companies takes place, in particular with regard to the functionality of the pharmacovigilance system and the fulfilment of the regulatory requirements.

The analysis focuses of our on-site pharmacovigilance audits include, among others:

• existing documentation (SOPs, organisation charts, workflows, etc.)
• documentation of and handling of reports (ICSRs, SUSARs, etc.) and reports (PSURs, annual reports, etc.)
• database systems
• internal and external interfaces
• staff interviews

As results, in addition to a detailed audit report you receive, among other things, specific analyses of improvement possibilities and optimisation potential as well as, if required, an action plan to remediate findings, which is drawn up in close coordination with you.