Audits & the Inspections

Due to legal requirements (see, amongst others, Article 13 of Implementing Regulation (EU) No. 520/2012), marketing authorization holders of medicinal products must conduct risk-based audits of their quality systems.

The planning, execution and follow-up of such audits are extremely time-consuming. In addition, these audits must be carried out by personnel who, on the one hand, has the appropriate qualifications but, on the other hand, has no direct involvement in or responsibility for the issues or processes to be audited.

Therefore, the commissioning of an external auditor is a resource-saving opportunity for many companies. Phavigus supports you in this area with the following services:

• Planning, preparation, execution and follow-up of internal audits of pharmacovigilance systems or selected pharmacovigilance processes and the associated quality management systems

• Auditing of pharmacovigilance systems and associated quality management systems of license partners, marketing & sales partners, service partners and other relevant third parties

• Preparation for and attendance of upcoming pharmacovigilance inspections by authorities or pharmacovigilance audits by third parties