I.B.6. Responsibilities for the quality system within an organisation

A sufficient number of competent and appropriately qualified and trained personnel shall be available for the performance of pharmacovigilance activities [IR Art 10(1), Art 14(1)]. Their responsibility should include adherence to the principles defined in I.B.5..

For the purpose of a systematic approach towards quality in accordance with the quality cycle (see I.B.3.), managerial staff (i.e. staff with management responsibilities) in any organisation should be responsible for:

• ensuring that the organisation documents the quality system as described in I.B.11.;
• ensuring that the documents describing the quality system are subject to document control in relation to their creation, revision, approval and implementation;
• ensuring that adequate resources are available and that training is provided (see I.B.7.);
• ensuring that suitable and sufficient premises, facilities and equipment are available (see I.B.8.);
• ensuring adequate compliance management (see I.B.9.);
• ensuring adequate record management (see I.B.10.);
• reviewing the pharmacovigilance system including its quality system at regular intervals in riskbased manner to verify its effectiveness (see I.B.12.) and introducing corrective and preventive measures where necessary;
• ensuring that mechanisms exist for timely and effective communication, including escalation processes of safety concerns relating to medicinal products within an organisation;
• identifying and investigating concerns arising within an organisation regarding suspected nonadherence to the requirements of the quality and pharmacovigilance systems and taking corrective, preventive and escalation action as necessary;
• ensuring that audits are performed (see I.B.12.).

In relation to the management responsibilities described above, upper management within an organisation should provide leadership through:

• motivating all staff members, based on shared values, trust and freedom to speak and act with responsibility and through recognition of staff members’ contributions within the organisation; and
• assigning roles, responsibilities and authorities to staff members according to their competencies and communicating and implementing these throughout the organisation.

For competent authorities, all persons involved in the procedures and processes of the quality system established for the performance of pharmacovigilance activities shall be responsible for the good functioning of that quality system and shall ensure a systematic approach towards quality and towards the implementation and maintenance of the quality system [IR Art 8(5)].