Inspection is a method of regulatory control by an authorized organization (usually regulatory) of the pharmacovigilance system of the inspected organization – the holder of registration certificates, the developer of medicines or another organization involved in the fulfillment of all or individual obligations under pharmacovigilance.
Our company provides such a service as examination of readiness for inspection. Based on the results of the examination, the risk assessments carried out, we will develop recommendations for preparing the pharmaceutical organization for the inspection of the pharmacovigilance system, and also help to implement them if necessary.
You can either consult with us or order the service immediately:
We also offer you to get acquainted with the main aspects of the inspection of the pharmacovigilance system:
The processes of planning, performing, documenting, and follow-up of pharmacovigilance system inspections are regulated by the Good Pharmacovigilance Practices (GVP) and local regulations.
In accordance with the requirements of national and international Rules of Good Pharmacovigilance Practices (GVP), scheduled or unscheduled inspections are carried out by an inspection team (at least two inspectors) at the actual place of pharmacovigilance activities (FN) (office of the other, vendor, etc. d.) in order to confirm the availability of personnel, systems, as well as premises, facilities and equipment necessary to fulfill their obligations under the FN, and to identify, assess and register inconsistencies (which may pose a risk to public health) in documents and processes, as well as to inform the inspected party and the commission of the regulatory authority about the results of the inspection.
If there are comments in the inspection report, the pharmaceutical organization prepares and implements a plan of corrective and preventive actions(CAPA). Before the inspection, the authorized regulatory organization planning to conduct it requests from the inspected organization the master file of the Pharmacovigilance System (pharmacovigilance system master file, PSMF). This document is used to prepare an inspection program that evaluates the Pharmacovigilance system (as a whole) and the Pharmacovigilance system quality system — the organizational structure, responsibilities, procedures, processes and resources of the inspected Pharmacovigilance system, including proper management of its resources, documentation and compliance with regulatory standards.
We remind you that our company also provides such a service as creating a Master File..
The results of the inspection can be used to justify regulatory actions against the inspected organization, which is obliged to promptly eliminate each identified nonconformity by developing and implementing CAPA.