The pharmacovigilance system audit – is the regular, ordered, independent and documented process of collecting the information and impartial assessment of the facts, which represents the functioning of the pharmacovigilance system [1]. The main goal of conducting the pharmacovigilance system audit is the confirmation of compliance, implementation and functioning efficacy of the pharmacovigilance system through the analysis and estimation of the objective facts, including the pharmacovigilance quality system. [1].
The audit is planned on the strategic (long-run), tactic and operating level.
The PV audit strategy should comprise the organization of process management, risk-management and means of the internal control of all the pharmacovigilance system components, including the following:
- a) all the processes and tasks of the pharmacovigilance system;
b) the quality system;
c) interaction and nexus with other departments (if necessary);
d) PV events held by the affiliated subsidiaries or delegated to the other organization (i.e. to the regional centers, providing the information, to the branch offices of the market authorization holder; to such third parties as outsourcing firms and other market authorization holders) [1].
The strategic audit programme is based on the proper risk assessment and ought to be geared to the estimation of next aspects:
- a) the quality system of the pharmacovigilance system;
- b) critical process steps in the PV system;
- c) the key control systems, which are based on the pharmacovigilance actions;
- d) the areas of high risk after implementation of the control procedure and risk-minimization measures[1].
Operating-level planning and fieldwork. The organization should introduce the procedures, enacted as the documents in written form, taking into account the planning and conducting several audits. The execution period of all the measures, necessary for the conducting the particular audit, should be fixed in the related procedures, connected to the audit conduction. The organization has to provide audit conduction in accordance with these procedures as described herein. The particular audits of the pharmacovigilance system have to be conducted in accordance with the approved audit programme, based on risks[1].
The auditors’ conclusions are formalized in the audit report and are presented to the directorship in time. The audit process should include the mechanisms of audit conclusions disposal to the auditee, receiving the feedback and presentation of the engagement communication to the directorship and to the other concerned parties, including the persons responsible for the pharmacovigilance system, in accordance with the legal requirements of the state-members and international agreements and acts, composing the entitlement of the Union, and recommendations about the pharmacovigilance system audit. The audit results should be presented in accordance with the relative risk level and be classified with the purpose of pointing out their significance towards the risks, influencing the pharmacovigilance system, its processes and the process components. The classification system should be defined in the description of the pharmacovigilance quality system and should take into account these threshold values, which should be used in the further reporting: — we define as critical the essential non-compliance of one or some processes or running procedures of the pharmacovigilance system, which negatively affect the whole pharmacovigilance system and (or) rights, safety and well-being of patients, and (or) represents the potential threat for the public health and (or) grave violation of the legal requirements of the state-members and international agreements and acts, representing the Union law;
— we define as significant the essential non-compliance of one or many processes or running procedures of the pharmacovigilance system, or the critical weakness of no matter which part of the one or many processes or running procedures, which negatively take a toll on the whole process and (or) potentially may affect the rights, safety and well-being of the patients, and (or) may represents the potential danger for the public health and (or) is the grave violation of state-members and international agreements and acts legal requirements, which together are representing the Union law, which, however, is not recognized as crucial.
We define as unessential the non-compliance of any component of the one or many processes or running procedures of the PV system, which according to expectations will not negatively affect the whole pharmacovigilance system or the process, and (or) the rights, safety and well-being of the patients. [1].
It’s highly crucial to immediately inform the auditee directorship and top-management regarding the issues, which have to be solved urgently[1].
Литература:
1. Правила надлежащей практики фармаконадзора [Электронный ресурс] : http://pharmacopoeia.ru/obrashhenie-lekarstv-v-evrazes-demo/pravila-nadlezhashhej-praktiki-farmakonadzora-evrazijskogo-ekonomicheskogo-soyuza/audit-sistemy-farmakonadzora/