Audits
Pharmacovigilance audits
Part of quality management and inspection preparation
The regular auditing of the company’s own pharmacovigilance systems – incl. subsidiaries – as well as the contracted partners – including distributors and pharmacovigilance service providers – required by the German Medicines Act (AMG) and Module IV “Audit” of the Good Pharmacovigilance Practices Guideline, among others, is a growing challenge for many MAHs.
subsidiaries – as well as the contracted partners – including distributors and pharmacovigilance service providers – represents a growing challenge for many MAHs.
This is where we apply our many years of pharmacovigilance expertise and have developed a specific audit program that focuses on both the regulatory requirements and the needs of the medium-sized pharmaceutical industry.
Our qualified auditors carry out pharmacovigilance-specific audits throughout Europe as a component of your company’s own quality management, in preparation for an official inspection, as an internal training measure or as a consulting measure on the occasion of regulatory changes.
This involves a systematic review and evaluation of the pharmacovigilance system of your company and/or your contracted partner companies, in particular with regard to the functionality of the pharmacovigilance system and compliance with regulatory requirements.
The analysis focus of our on-site pharmacovigilance audits include
- Existing documentation (SOPs, organizational charts, workflows, etc.)
- Documentation and handling of notifications (ICSRs, SUSARs, etc.) and reports (PSURs, annual reports, etc.)
- Database systems
- Internal and external interfaces
- Employee interviews
In addition to a detailed audit report, you will receive specific analyses of opportunities for improvement and optimization potential as well as an action plan for remedying findings, if required, which will be drawn up in close consultation with you.
