The Audit Process
PV Focus will bring its expertise and tools to assist in the identification of the processes to be covered, as relevant to the site(s) audited. For example, the following processes could be considered for a routine Pharmacovigilance Audit:
- Responsibilities and Organisation for Pharmacovigilance
- Interaction between Drug Safety and the Medical Information Organisation (Medical Enquiries)
- Interaction between Drug Safety and Technical Quality Assurance Organisation (Quality Complaints)
- Literature Screening
- Management of Safety related Processes in Clinical Trials
- Processing and Submission of Individual Cases
- Periodic Safety Reporting (PSUR, DSUR...)
- Signal Detection and Management
- Core Safety Information
- Maintenance of approved Product Information
- Risk Management / Pharmacovigilance Planning
- Quality Management Systems
- Validation of Computer Systems, Security, Back-up and Disaster Recovery
The Time and Cost Estimate for the audit will depend on the number of topics included in the scope of the audit, and selected on the basis of their relevance to the organisation audited. Based on experience, a routine Pharmacovigilance Audit can be conducted within 2 to 5 working days.
Subject to agreement with the client, the scope for the audit and all timelines for the Audit Process would be described in the Audit Plan, which is established specifically for each Pharmacovigilance Audit.
Pre-Audit Questionnaire & Audit Agenda
Also used by some Regulatory Authorities to prepare for Pharmacovigilance Inspections, a Pre-Audit Questionnaire is used to collect preliminary information which will be used to define the proposed agenda for the audit and to make the conduct of the audit more efficient.
A detailed Agenda will be designed specifically for each Pharmacovigilance Audit to facilitate the organisational aspects of the Audit conduct.
Prior to the actual Pharmacovigilance Audit, PV Focus generally performs a detailed review of relevant organisational documents. This would typically include relevant Company SOPs, but also additional documents such as Pharmacovigilance Agreements with Marketing Partners. In addition to gaining awareness of the company processes, this allows to save time for the actual conduct of the audit and contributes to making the Audit most efficient.
On site, the conduct of a Pharmacovigilance Audit generally starts with an opening meeting where the project is presented. The audit includes interview of relevant personnel and associated document reviews, and these activities follow a comprehensive Audit Worksheet to promote consistency and thoroughness. A closing meeting is systematically held where the preliminary audit results are presented.
Reporting and Follow-Up
Although the format is adapted to each Client's requirements, the Audit Report generally specifies which topics have been covered during the Audit with a detailed description of the issues detected, together with an Executive Summary. A significance rating and proposed actions are generally included for each deficiency identified.
Depending on the processes in place at the Client, a draft report may be reviewed by Auditees and or Quality Assurance personnel prior to the release of the Final Report.If required, an Audit Certificate can also be provided to confirm that the Audit was performed.
Regarding Follow-Up activities, the development and implementation of Corrective And Preventative Action Plans (CAPA Plans) is routinely monitored by the Client's Quality Assurance personnel but PV Focus can also offer assistance and support during this phase of the Audit Process.