Quality system in pharmacovigilance
PSK Pharma aligns all R&D, production and business processes in accordance with high national and international quality standards. In particular, good practices play an important role in the pharmacovigilance department.
Like all Good Practices, the Good Pharmacovigilance Practice (GVP) has a quality system. The quality system is an integral part of the pharmacovigilance system – is the basis of GVP.
GVP contains definitions of pharmacovigilance system and pharmacovigilance quality system. Thus, when implementing a pharmacovigilance system, a company has to implement two systems. However, here comes the question, what is initial: the pharmacovigilance system or the quality system of the pharmacovigilance system? The process is created first, and then it is filled with assurances, i.e. the quality system.
For GVP, quality is defined as follows - all system characteristics that, according to the probability estimation, lead to outcomes that are consistent with the objectives of the pharmacovigilance system.
It is necessary to create control points in order to ensure proper functioning of the system. For this purpose, there are operational indicators in the system, they are assessed by the qualified person for pharmacovigilance on a quarterly basis as part of the preparation of the master file of the pharmacovigilance system, which allows to properly plan and conduct audits of the pharmacovigilance system of the marketing authorization holder, as well as inspections from the regulatory authority. But there are also target performance indicators for each element of the pharmacovigilance system, so-called process performance indicators, to determine whether the process is working properly. Since it is only possible to learn about the quality of decisions about the process in the future, there must be a proper analysis for this.
In order for a given strategy to work, a control system must be in place and audits must be carried out. As in any other quality system, GVP has a PDCA (“Plan-Do-Check-Act”) cycle.
So what does the pharmacovigilance quality system cover?
1. Organizational structure, which presents the hierarchical relationship of management and supervisory staff, indicating the location of the qualified person for pharmacovigilance.
2. The staff who must have qualifications and experience appropriate to the functions to be performed, such staff must be available in sufficient numbers, and regular training is required.
3. A qualified person for pharmacovigilance with appropriate qualifications, practical and theoretical experience.
4. Resources (equipment, facilities, etc.).
5. Processes: pharmacovigilance is a set of processes where there are critical processes that need to be monitored. These are defined in the GVP.
6. Documents (Pharmacovigilance Policy, Pharmacovigilance Documentation Management Policy, Pharmacovigilance Quality Manual, Pharmacovigilance.
Quality Plan, Procedures (SOPs), Pharmacovigilance Quality Reports, Pharmacovigilance Master File).
One way to build a pharmacovigilance quality system is to integrate it with the manufacturer's quality system. This method is appropriate because, firstly, the quality system is an integral part of the pharmacovigilance system and is based on the same principles and standards, and secondly, according to the GVP “all specialists who perform work on the organization of the quality system are responsible for ensuring that the pharmacovigilance system operates in accordance with the requirements for the quality system. It is necessary to ensure a systematic approach to the implementation and maintenance of the quality system at an appropriate level”.
Both the pharmacovigilance and the manufacturer's quality system have common and specific processes (in pharmacovigilance they are called critical processes, in the manufacturer's quality system they are defined in Good Manufacturing Practice). For example, the order of operation of the tablet press and the order of preparation of the periodic safety report are different processes of the two systems, but the order of staff training and approaches to staff training will be common and the same for both the quality system of the pharmacovigilance system and the manufacturer's quality system. For this purpose, integration of the two systems would be convenient.
In addition to staff training, common elements of the pharmacovigilance and manufacturer's quality system will also include: resource management, outsourcing, document and records management, process control and monitoring system, deviation management, non-conformities, CAPA, change control, management review, audits and inspections.
Regular review of the performance of the quality system by the management reviewing the quality system documentation is essential. The frequency and intensity of this review will be determined by pre-planning, reasonable risk, and the system review programs that are developed.
Thus, the holders of the registration certificates are responsible for carrying out the pharmacovigilance tasks and responsibilities defined by the GVP, in order to ensure that the obligations are met and to take the required pharmacovigilance measures for registered medicinal products, if necessary. To this aim, the marketing authorization holders should ensure the functioning of the pharmacovigilance system in the territories of the Member States, including the implementation of an appropriate and effective quality system for the pharmacovigilance system.