I.B.12. Monitoring of the performance and effectiveness of the pharmacovigilance system and its quality system

Processes to monitor the performance and effectiveness of a pharmacovigilance system and its quality system should include:

• reviews of the systems by those responsible for management;
• audits;
• compliance monitoring;
• inspections;
• evaluating the effectiveness of actions taken with medicinal products for the purpose of minimising risks and supporting their safe and effective use in patients.

The organisation may use performance indicators to continuously monitor the good performance of pharmacovigilance activities [IR Art 9(1)] in relation to the quality requirements. The quality requirements for each pharmacovigilance process are provided in each Module of GVP as appropriate.

The requirements for the quality system itself are laid out in this Module and its effectiveness should be monitored by managerial staff, who should review the documentation of the quality system (see I.B.11.) at regular intervals, with the frequency and the extent of the reviews to be determined in a risk-based manner. Pre-defined programmes for the review of the system should therefore be in place. Reviews of the quality system should include the review of standard operating procedures and work instructions, deviations from the established quality system, audit and inspections reports as well as the use of the indicators referred to above.

Risk-based audits of the quality system shall be performed at regular intervals to ensure that it complies with the requirements for the quality system, the human resource management, the compliance management, the record management and the data retention and to ensure its effectiveness [IR Art 13(1), Art 17(1)]. Audits of the quality system should include audit of the pharmacovigilance system which is the subject of the quality system. The methods and processes for the audits are described in Module IV. In relation to the pharmacovigilance system of a marketing authorisation holder, a report shall be drawn up on the results for each quality audit and any follow-up audits be sent to the management responsible for the matters audited [IR Art 13(2)]. The report should include the results of audits of organisations or persons the marketing authorisation holder has delegated tasks to, as these are part of the marketing authorisation holder‘s pharmacovigilance system. For competent authorities, the audit report shall be sent to the management responsible for the matters audited [IR Art 17(2)].

As a consequence of the monitoring of the performance and effectiveness of a pharmacovigilance system and its quality system (including the use of audits), corrective and preventive measures should be implemented when deemed necessary. In particular as a consequence of audits, corrective action(s), including a follow-up audit of deficiencies, shall be taken where necessary [IR Art 13(2), Art 17(2)]. Additionally, the competent authorities should have in place arrangements for monitoring the compliance of marketing authorisations holders with legally required pharmacovigilance tasks and responsibilities. They shall further ensure compliance with the legal requirements by means of conducting inspections of marketing authorisation holders [DIR Art 111(1)] (see Module III). Guidance on compliance monitoring for each pharmacovigilance process is provided in each Module of GVP as appropriate.

Requirements and methods for evaluating the effectiveness of actions taken upon medicinal products for the purpose of minimising risks and supporting the safe and effective use of medicines in patients are described in Module XVI.