The Pharmacovigilance Quality System. What is it?

Transcription

1 The Pharmacovigilance Quality System What is it? by Andy Blackman 12 November 2018

2 Are you starting to plan your first Marketing Authorisation Application? If yes, now is the time to start developing your pharmacovigilance quality management system! Introduction This is the final of three commentaries published concerning pharmacovigilance (PV). As discussed in the first of these commentaries, the PV system is a system used by an organisation to fulfil its legal obligations and responsibilities in relation to PV. The PV quality system (QS) is an integral part of the PV system and consists of the organisational structure, responsibilities, procedures, processes and resources. TranScrip s PV team are experienced in setting up PV systems and their QS, as well as providing Qualified Person for Pharmacovigilance (QPPV) services. The PV Quality System An effective PV QS includes: controlled documents describing the quality system adequate resources and structures training suitable premises, facilities and equipment adequate compliance management adequate record management regular risk-based review of the PV system and QS to verify effectiveness corrective and preventive actions (CAPA) where necessary processes for identifying and investigating concerns regarding suspected nonadherence regular risk-based audits As described in the second commentary, the marketing authorisation holder (MAH) or applicant needs to ensure that the QPPV has sufficient authority to influence the performance of the PV system and its QS. If an MAH or applicant has contracted PV tasks, it retains responsibility for ensuring that an effective quality system is applied in relation to those tasks. The ultimate responsibility for the fulfilment of all PV tasks and the quality and integrity of the PV system always remains with the MAH. Page 2 of 5

3 Description of the PV QS The PV QS must be documented in a systematic and orderly manner in the form of written policies and procedures, such as quality plans, quality manuals and quality records. The quality plan documents the setting of quality objectives and should set out the processes to achieve them. The quality manual should document the scope of the QS, its processes and the interaction between the two. A quality record is any document stating results achieved or providing evidence of PV-related activities performed. Training Training plans and records of maintaining and developing the competences of personnel need to be documented. The training plans should be based on training needs assessment, and subject to ongoing monitoring. All staff across the organisation should receive training on what to do if they become aware of a safety concern. Adequate training must be considered for staff members who do not have specific PV tasks and responsibilities, but whose activities may impact the PV system or the conduct of PV, for example, staff involved in clinical trials, technical product complaints, medical information, sales and marketing, regulatory affairs and legal affairs. Equipment The facilities, equipment and computerised systems which are critical for the conduct of PV and should be subject to appropriate checks, qualification and/or validation activities to prove their suitability for the intended purpose. Such qualification activities must be documented. Compliance Management To manage compliance, procedures and processes should be in place to ensure the: continuous monitoring of PV data to identify options for risk minimisation and prevention scientific evaluation of all information on the risks of products, particularly adverse reactions submission of timely, accurate and verifiable data on adverse reactions to the authorities quality, integrity and completeness of the information submitted effective communication with authorities, including communication on new or changed risks, the pharmacovigilance system master file (PSMF), risk management systems, risk minimisations measures, periodic safety update reports, CAPA and post-authorisation safety studies update of product information in the light of scientific knowledge Page 3 of 5

4 appropriate communication of safety information to healthcare professionals and patients Record Management A record management system needs to be in place to support the management of the quality of PV data, including their completeness, accuracy and integrity; timely access to all records; effective internal and external communication; and the retention of documents relating to the PV systems and the conduct of PV for individual medicinal products, in accordance with the applicable retention periods. Performance and Effectiveness of the PV System Processes need to be in place to monitor the performance and effectiveness of the PV system and its QS. These should include: review of the systems by those responsible for their management audit planning audits of PV processes and service providers compliance monitoring inspections evaluating the effectiveness of risk minimisation measures CAPA should be implemented when deemed necessary Performance indicators can be used to continuously monitor the performance of PV activities in relation to the quality requirements and are useful for early identification of issues which impact quality and compliance. Conclusion The design and set-up of a PV QS is a time-consuming task and requires careful planning to ensure full integration with the PV system. Resource requirements need to be assessed and numerous documents need to be written including standard operating procedures and the PSMF. It is recommended that the planning and development of a PV system and its QS should commence before planned submission of the marketing authorisation application. Page 4 of 5

5 How can TranScrip help? TranScrip s PV operational experts have hands on experience in developing PV systems and their QS. We provide expertise and resourcing to over 200 pharmaceutical companies. We also provide QPPVs, PV physicians, and medical writing resource and expertise. For further information Contact Andy Blackman andy.blackman@transcrippartners.com References GVP Module I Pharmacovigilance systems and their quality systems (2 July 2012) Page 5 of 5