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Risk Assessment Criteria for PV Audits



  • David
    22/06/2016 13:51
    Dear all, I would like to know which are the most common criteria to perform the risk assessment for PV Audits. Is it sales, pv responsibility of the party, history? Looking forward for a feedback. Kind Regards, David
  • GPvP Committee
    13/07/2016 17:54
    Hi David, GVP Module IV (Rev 1) ‘Pharmacovigilance audits’ provides detail on the types of criteria to perform risk assessments but at a Company level it would be dependent on the activities undertaken in-house, with Partners or third party Suppliers. Ultimately each Company would have to define what was specific to them / their product. The risk-based approach to audits as referenced in Module IV recommends focusing on the areas of highest risk to the organisation’s pharmacovigilance system, including its quality system for pharmacovigilance activities. Section IV.B.2 provides more in depth strategy for consideration. Additionally the RQA have published the PV Auditing Booklet which provides further detail.
  • GPvP Committee
    15/07/2016 11:10
    In addition to this, the specific areas that can be assessed for risk assessments include: •Time since last audit •Whether the system or process has been audited •Significant findings from: Previous audits, PV Inspections •Open findings from: Previous audits, PV Inspections •Other issues identified during: Internal Audits, External Audits, PV Inspections •Issues identified during regular Compliance / PV QA Meetings, such as: Case submission compliance, Risk Management Compliance, PSUR compliance – preparation and submission, Identified procedural gaps, Other known risks •Changes to legislation / PV Guidance •Procedural changes •Changes to technology / electronic systems, e.g. safety database •Changes to personnel: Reduction in staff numbers, Changes in the number and availability of adequately trained and experienced PV staff, Changes to key personnel / managerial functions, Significant staff turnover •Increased volume of work •PV activities being outsourced •Major re-organisation or re-structuring of: PV System, Mergers, Other supporting functions in the company •Deficiencies identified in training of PV personnel •Products on the market with additional monitoring or risk minimisation measures •Safety profile of concerned products (Third Party audits only) – products with a well-established safety profile usually generate fewer novel ICSRs, which usually means less activity regarding Signal Management •Criticality of processes / activities (for processes, affiliates or Third Parties): Potential impact on PV System, Potential impact on patient safety
  • Dan
    29/03/2019 10:07
    For PV audit planning is common to perform a risk analysis as the PIC/S one? collecting score from criticality, complexity and compliance and merge them to have a final score? or it is better just to have a single list of parameters to which give a score...
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