PV-System – PSMF (Pharmacovigilance System Master File) & Written Procedures

The “Guideline on good pharmacovigilance practices” (GVP) challenges every MAH’s PV system and requires the implementation of several novelties. One of the most extensive tasks is the compilation of the Pharmacovigilance System Master File (PSMF) as a tool for the QPPV’s oversight of the PV system. Critical PV processes have to be outlined in the PSMF and described in detail in the respective SOPs.

The PSMF requires detailed descriptions of PV processes addressing also the interactions between different departments within your company. The annexes of the PSMF contain comprehensive data demonstrating the current state of the PV system, including:

  • An overview of all marketing authorisations covered by the PSMF together with information on presence on the market (also outside EU) and specific safety monitoring requirements
  • Results of the current performance assessment (e.g. timeliness of ICSR reporting and PSUR submission, safety variations and adherence to RMP requirements)
  • An audit schedule and critical findings from previous PV audits
  • A detailed overview on the company’s written procedures

Our Concept

We offer the preparation of the PSMF and the related Summary of Pharmacovigilance System according to GVP – Module II “Pharmacovigilance system master file”. You may choose between a basic version and a full version, where the annexes are compiled in collaboration with you containing company-specific data.
After identifying your company-specific procedures regarding PV, we can help to update your existing PV SOPs and close gaps with regard to critical procedures according to GVP – Module I “Pharmacovigilance systems and their quality systems”.

Please don’t hesitate to contact us for an individual offer.