Role of International PVQA Allison Jack, PVQA Director, GSK 24 th October 2017, Milan
Agenda What does Regulations say about audits? Expectations of PVQA Organisation of PVQA What qualifications does a PVQA auditor need to have? Types of PVQA audits Risk rating Approach to audit conduct PSMF LP audits Metrics 24 th October 2017 2
What does Regulations say about audits? GVP Module I Pharmacovigilance systems and their quality systems Section I.B.7 Training of personnel for pharmacovigilance Adequate training should also be considered by the organisation for those staff members to whom no specific pharmacovigilance tasks and responsibilities have been assigned but whose activities may have an impact on the pharmacovigilance system or the conduct of pharmacovigilance. Such activities include but are not limited to those related to clinical trials, technical product complaints, medical information, terminologies, sales and marketing, regulatory affairs, legal affairs and audits. Section I.B.11 Documentation of the quality system The quality system shall be documented by: reports of quality audits and follow-up audits, including their dates and results Section 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: audits 3
What does Regulations say about audits? GVP Module I Pharmacovigilance systems and their quality systems Section I.B.12 Monitoring of the performance and effectiveness of the pharmacovigilance system and its quality system 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. 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)]. 4
What does Regulations say about audits? GVP Module II Pharmacovigilance System Master File (PSMF) Section II.B.4.7 PSMF section on quality system Information about quality assurance auditing of the pharmacovigilance system should be included in the PSMF. A description of the approach used to plan audits of the pharmacovigilance system and the reporting mechanism and timelines should be provided, with a current list of the scheduled and completed audits concerning the pharmacovigilance system maintained in the annex referred to II.B.4.8. The PSMF shall also contain a note associated with any audit where significant findings are raised. This means that the presence of findings that fulfil the EU criteria for major or critical findings must be indicated. In case corrective and preventative action plan(s) have not yet been agreed for a particular audit or finding, the PSMF should include the note required and stating that corrective and preventative action plan(s) are to be agreed. 5
What does Regulations say about audits? GVP Module IV Pharmacovigilance audits Section IV.B.1. Pharmacovigilance audit and its objective Pharmacovigilance audit activities should verify, by examination and evaluation of objective evidence, the appropriateness and effectiveness of the implementation and operation of a pharmacovigilance system, including its quality system for pharmacovigilance activities In the context of pharmacovigilance, audit criteria should reflect the requirements for the pharmacovigilance system, including its quality system for pharmacovigilance activities, as found in the legislation and guidance The risk-based approach to pharmacovigilance audits Competence of auditors and quality management of audit activities Independence and objectivity of audit work and auditors Qualifications, skills and experience of auditors and continuing professional development 6
Expectations of PVQA To give reassurance to QPPV Meet regulatory expectation (GVP Module IV, section IV.B.1) Should be independent Take a risk based approach Ensure CAPAs management system in place Utilise qualified and experience auditors Need to be able to audit against different local PV requirements Provision of audit data for PSMF Insert your date / confidentiality text here 7
Organisation of PVQA Dedicated PV auditors vs. Generalists? 8
What qualifications does a PVQA auditor need to have? Is it better to have an auditor that has a PV operational background or a general auditor such as ISO accredited auditor? ISO auditors are good at looking at QMS aspects and this is key basis to GVP Module I ISO auditors are not always experts in the regulations they are auditing so may miss key requirements PV auditor with operational background has the key technical background to understand area to be audited and how relates to regulations PV auditor with operational background need to learn the auditor technical skills Auditor with another GxP background already has the auditing technical skills but not the PV technical knowledge 9
Types of PVQA audits Affiliate PV Critical Processes (as defined in GVP Module I) Licensing Partners/Distributors External Service Providers (case processing, literature, etc.) REMS (US requirement) Follow-up audits Verification audits 10
Risk rating GVP expects a risk based approach to be utilised at 3 levels: Strategic Level - 2-5 years strategy - audit universe Tactical Level - annual plan Operational Level - individual audits 11
Approach to audit conduct PSMF - There is an expectation that data in PSMF will be utilised in taking a risk based approach to audits: Data in PSMF includes: List of affiliates List of ESPs List of Market research, Patient Support Programmes and Interactive Digital Media activities List of Licensing Partners Data can be used at all levels of risk based planning 12
Metrics PVQA should consider what metrics are critical for own effective operations and also key stakeholders needs. Metrics can include: Time to issue draft/final reports Time to receive CAPA plan from auditee Time to CAPA closure Number of open CAPAs Number of overdue CAPAs 13
Conclusion There is a regulatory imperative for the need of PVQA auditors Ideally an auditor with a PV operational background to fulfil regulatory expectations but an auditor with ISO or GxP auditing experience and is adaptable and has agility to learn can be just as good. Inspectors do look at training and experience of auditors as well as strategies and risk based approach to auditors The role of PVQA is beyond just the EU requirement as many other countries have adapted GVP and expect a PVQA function (EEU, Arabic countries etc.) 14