The expertise and its tools to assist in the identification of the processes to be covered, as relevant to the sites audited will be compiled and presented by pharmacovigilance audit. Some of the processes to be carried during a pharmacovigilance audit are maintaining Core Safety Information, ensuring Periodic Safety Reporting (PSUR, DSUR…), to involve in a possible, Interaction between Drug Safety and Technical Quality Assurance Organization (Quality Complaints), roll out Literature Screening, assessing relevant Responsibilities and Organization for Pharmacovigilance, to interact between Drug Safety and the Medical Information Organization (Medical Enquiries), managing safety-related Processes in Clinical Trials, to process and submit the possible results of Individual Cases, performing Signal Detection and management, overseeing Risk Management including pharmacovigilance planning, to take privilege in the Maintenance of approved Product Information and Validation of Computer Systems, Security, Back-up and Disaster Recovery, to formulate training and Quality Management Systems.
In order to determine the ideal or approximate time intervals required for a pharmacovigilance audit, it is very important to assign pre-audit questionnaire and audit agenda. A Pre-Audit Questionnaire is used to collect preliminary information and it is also employed by some Regulatory Authorities to prepare for Pharmacovigilance Inspections. The information collected in the pre-audit questionnaire will be used to define the proposed agenda for the audit and to make the conduct of the audit more efficient. To facilitate the organizational aspects of the Audit conduct, a detailed Agenda will be designed specifically for each Pharmacovigilance Audit. A detailed review of relevant organizational documents will be performed in the pharmacovigilance audit focus before the actual process of a pharmacovigilance audit. Relevant company documents such as Company SOPs, Pharmacovigilance Agreements in association with the Marketing Partners. The actual conduct of the audit contributes to making the Audit most efficient upon the successful consideration of gaining awareness of the company processes which also helps saving time.
The project will be presented with an official opening meeting which will be regarded as the conduct of a Pharmacovigilance Audit that is generally conducted on site. A comprehensive worksheet schedule will be allotted in order to promote consistency and thoroughness with respect to the data obtained out of relevant personnel who are associated with document reviews and several other activities. All the preliminary audit results will be presented at the closing ceremony that will be held systematically according to the norms.
The Audit Report generally specifies which topics have been covered in spite of the format being adapted to each Client’s requirements. The information obtained during an Audit will be a detailed description of the issues detected, together with an Executive Summary which will be rated according to the actions that are significant actions with respect to the individual proposals and deficiencies that have been identified during the process.
A draft report shall be reviewed by the auditees corresponding to the processes that will be further analyzed and reported by the quality assurance personnel before the release of the final report. In addition a strong affirmation can also be provided in the case where an audit certificate is required for assurance and when it comes to the 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.
Based on the relevance to the organization audited the time and cost Estimate for the audit will depend on the number of topics included in the scope of the audit. Within two to five days a routine Pharmacovigilance Audit shall be conducted considering the experience. The scope of the audit and all timelines for the Audit Process would be described in the Audit Plan which would be subjected to an agreement with the client.