Could I ask were in the PV legislation does it mention that the reconciliation processes should be done in both directions (between the Quality and Pharmacovigilance department) for PQC-AE reports? Does the frequency for example real-time acknowledgement or periodic (weekly, monthly) need to be documented as a company decision?
Thank you for the support.
Dear PIPA Member,
Thank you for posting your question and please accept our apologies for the delay in replying.
Regarding your question, where in the PV legislation does it mention that the reconciliation processes should be done in both directions (between the Quality and Pharmacovigilance department) for PQC-AE reports, please find the response below:
I can confirm that although there are no specific legislation’s relating to the reconciliation process between the quality department and the pharmacovigilance department, as per GVP VI VI.B.4. Data management, When transfer of pharmacovigilance data occurs within an organisation or between organisations having set up contractual agreements, the mechanism should be such that there is confidence that all notifications are received; in that, a confirmation and/or reconciliation process should be undertaken.
It is good company practice to perform reconciliation to ensure that that all PQCs with an associated SAE/AE has been forwarded onto the PV department as per the company safety timeline i.e.; 24 hours/1 business day. I can see no harm why this cannot be done on a monthly basis to ensure you have captured the relevant safety/quality information.
I do hope this helps in answering your query.
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