Due to the current situation originated by COVID-19, the Spanish Agency for Medicines and Health Products (AEMPS) announced last week that in order to allow the normal activity of Marketing Authorisation Holders (MAHs) and to be able to supervise it adequately, the Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GMP) inspection area will carry out remote pharmacovigilance inspections whenever possible, including it within the risk-based inspection plan, in place since 2016.
Therefore, the AEMPS recommends MAHs to update their remote video communication systems, document exchange platforms, and check access to their own systems as well as those of third parties related to any pharmacovigilance activity.
The GCP and GMP inspection department will communicate with the contact person for Pharmacovigilance/QPPV of the MAHs to be audited in order to evaluate if remote inspection is possible. Once evaluated, the inspection will be announced through the LABOFAR inspection management system. From there, the communication between the auditing and audited teams will be carried out in the usual way.
At Asphalion we have an expert team in PV audits and we carry out both audits of the client’s PV system and subsidiaries, distributors, service companies, etc. We are experts in both on premises and remote audits, due to that we know which are the challenges to be faced during remote audits. In the audits we adapt to customer requirements and current regulations. The audits have a training-type character with the focus of helping clients to improve their PV system. Apart from detecting the findings and classifying them according to their criticism, these findings are reviewed and accompanied by recommendations on how to solve them.
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