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GVP audit scheduling

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  • Anon
    14/07/2015 14:53
    Hi, If you were assessing and scheduling your time to conduct audits of pharmacovigilance systems (GVP), what average time (in hours) would you suggest for the following size of audits (including preparation, onsite audit, report writing and CAPA review): 1) ICSR received per year: Up to 1000 - Safety variations submitted per year: From 4 to 10 2) ICSR received per year: From 1000 to 3000 - Safety variations submitted per year: From 11 to 20 3) ICSR received per year: From 3000 to 10000 - Safety variations submitted per year: From 20 to 30 I appreciate this could be difficult to answer in a number of cases, but a rough idea would be appreciated. Thanks.
  • GPvP Committee
    02/11/2015 16:52
    The scope of the audit would determine the length of time required for the audit. Considerations in determining the audit scope for example may include % of cases to look at in detail, how many auditors would be performing the audit (and their level of experience), the nature of the CAPA review, how supporting data is managed and how efficient is the electronic data management system. Time management of onsite audits is determined by responsibility also, i.e. who is the MAH for the concerned products (the auditing party or the audited party), which ICSR activities are being performed (processing, follow up, medical review, regulatory submissions, compliance activities, etc.) and which aspect of safety variations is being audited (the question implies submissions only, which is a simple examination of compliance; if, however, variations are being incorporated into local RSI, then this will add an extra complexity / time to the audit process). The average in the industry is approx. 3 days for the audit conduct at site. However it is difficult to break it down into hours without further information as defined above, e.g. checking safety variation submission compliance could take a few minutes if all the documentation / evidence is available, but if more activities are being performed (translations, updates to national RSI, QC checks, etc.) then the process is obviously lengthened. Preparation, report writing and follow up is much harder to define and Companies would determine this based on their procedures, for example some Companies allow 20 calendar days to write and issue a report, others allow 30 days. CAPA follow up is then determined on a case by case basis
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