RISK ASSESSMENT IN PET RADIOPHARMACEUTICALS PRODUCTION: PLANNING THE IMPLEMENTATION OF A PRODUCTION LINE COMPLIANT WITH GMP REGULATION
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...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Center for Quality, Faculty of Engineering, University of Kragujevac, Serbia
2023-06-01
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| Series: | International Journal for Quality Research |
| Subjects: | |
| Online Access: | http://ijqr.net/journal/v17-n2/16.pdf |