I.B.2. Quality, quality objectives, quality requirements and quality system

For the purpose of GVP, which provides guidance on structures and processes of a pharmacovigilance system, the quality of a pharmacovigilance system can be defined as all the characteristics of the system which are considered to produce, according to estimated likelihoods, outcomes relevant to the objectives of pharmacovigilance.

In general terms, quality is a matter of degree and can be measured. Measuring if the required degree of quality has been achieved necessitates pre-defined quality requirements. Quality requirements are those characteristics of a system that are likely to produce the desired outcome, or quality objectives. The overall quality objectives for pharmacovigilance systems are provided under I.B.4..

Specific quality objectives and quality requirements for the specific structures and processes of the pharmacovigilance systems are provided in each Module of GVP as appropriate.

The quality system is part of the pharmacovigilance system and consists of its own structures and processes. It shall cover organisational structure, responsibilities, procedures, processes and resources of the pharmacovigilance system as well as appropriate resource management, compliance management and record management [IR Art 8(2)].