10th Italian National Meeting of Qualified Persons

10th Italian National Meeting of Qualified Persons

The 10th Italian National Meeting of Qualified Persons, promoted by a trade association, took place in Rome on the 25th November, 2016.

One of the topics discussed during the meeting was the data integrity.  The Italian Medicine Agency (AIFA) defined this as a key element within their inspections.  In fact, many Italian manufacturing sites are also authorised by the US FDA and this has forced the Agency to partially adapt their approach to that of the US Agency.  The deviations detected include data manipulation and information systems unsuitable for data control.

The AIFA has also confirmed that they have adopted a risk-based inspection system, i.e.  inspections are planned based on a risk assessment, with 6 months to 3 years intervals.  In this regard, the Agency is considering the activation of a dedicated portal for manufacturing sites to be managed by the QPs.

Finally, traceability was discussed: the  EU Falsified Medicines Directive (Directive 2011/62/EU) introducing obligatory “safety features” – a unique identifier and an anti-tampering device – to allow the serialisation and traceability shall not be applied for the time being, as a system is already in place, based on the application of antifraud stickers, which works very well.  However, Italian companies manufacturing for third parties for other countries shall be obliged to comply by maintaining the two traceability systems.

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