RISK ASSESSMENT IN PET RADIOPHARMACEUTICALS PRODUCTION: PLANNING THE IMPLEMENTATION OF A PRODUCTION LINE COMPLIANT WITH GMP REGULATION

Michela Poli, Davide Cornolti, Giorgio Iervasi, Silvia Pardini, Mauro Quaglierini, Alessandro Zega, Debora Petroni

Abstract: The aim of this paper is to provide some indications for carrying out the risk assessment for the activation of a production line of a radiopharmaceutical containing a positrons emitting radionuclide. The risk analysis was performed by following the ICH Q10 guideline and ISO 9001:2015 standards and by using the risk-based thinking approach applied to the entire production cycle. The overall analysis has shown that hard and soft skills of the expert group are key factors of success both in technical and radiopharmaceuticals-related preparations as well as in risk management methodologies.

Keywords: Radiopharmaceuticals, Risk assessment, Risk based thinking, GMP, Risk identification

DOI: 10.24874/IJQR17.02-16

Recieved: 04.02.2022  Accepted: 13.01.2023  UDC: 005.52:005.334

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