It is important that pharmacovigilance system is in order and up to date so that the safety of the medicine can be guaranteed throughout its life cycle.

Medimo Oy

Auditing

Auditing ensures compliance with good operating practices for medicines or medical devices. A standard operating procedure defines how often and what kind of audits should be conducted.

GVP audit of the pharmacovigilance system

The pharmacovigilance system SOP (standard operating procedure) determines how often and what kind of audits should be performed on the pharmacovigilance system. The pharmacovigilance system shall be audited regularly to ensure patient safety. In addition, the competent authority conducts inspections of marketing authorization holders’ pharmacovigilance systems. Auditing is based on EU regulations, GVP modules and pharmacovigilance agreements.

Pharmacovigilance systems audits of pharmaceutical companies
Pharmacovigilance tasks audits outsourced to service providers

We perform e.g. the following GMP-compliant audits:

Manufacturing plants (including sterile manufacturing)
Active substance plants
Packaging materials manufacturers
Contract laboratories and manufacturers
Distribution and transport in accordance with the pharmaceutical wholesale license required by GDP (Good Distribution Practice).

Audit of good regulatory practices (GRP)

Marketing authorisation activities are not subject to the authorities’ inspections, but since, for example, safety-related variation applications are essentially related to the pharmacovigilance of medicinal products, it is good to also audit marketing authorization activities:

Auditing of critical processes such as information flow, archiving, and quality control
Quality control of the SPC, package leaflet and package material versions, checking the up-to-dateness of national and/or own databases
Auditing of good regulatory practices (GRP)

We can manage the audits related to medicinal products and medical devices for you. Contact us – we’ll provide answers to your questions quickly!