Problem Solving › Logistics
Rottura della catena del freddo in distribuzione farmaceutica · Logistics · Advanced
You head distribution for a pharma operator. A data logger reports that a vaccine batch (worth 45,000 euros) exceeded 8°C for 3 hours in transit to 12 pharmacies, some already delivered. GDP rules require 2-8°C. You have obligations to the regulator and to patients. The vaccine supplier must be involved to assess stability. You must decide within hours, with full traceability required. How do you handle the incident and prevent recurrence?
Sei responsabile della distribuzione di un operatore farmaceutico. Un data logger segnala che un lotto di vaccini (valore 45.000 euro) ha superato gli 8°C per 3 ore durante il trasporto verso 12 farmacie, alcune già consegnate. La normativa GDP impone 2-8°C. Hai obblighi verso l'autorità regolatoria e i pazienti. Il fornitore del vaccino va coinvolto per valutare la stabilità. Devi decidere in poche ore, con tracciabilità completa richiesta. Come gestisci l'incidente e previeni il ripetersi?
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