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.
We perform e.g. the following GMP-compliant audits:
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:
We can manage the audits related to medicinal products and medical devices for you. Contact us – we’ll provide answers to your questions quickly!