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 |
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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 |
| _version_ | 1827927332233412608 |
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| author | Michela Poli Davide Cornolti Giorgio Iervasi Silvia Pardini Mauro Quaglierini Alessandro Zega Debora Petroni |
| author_facet | Michela Poli Davide Cornolti Giorgio Iervasi Silvia Pardini Mauro Quaglierini Alessandro Zega Debora Petroni |
| author_sort | Michela Poli |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-13T05:51:25Z |
| format | Article |
| id | doaj.art-f93ac0d175d04b1f8baad1c57c224fef |
| institution | Directory Open Access Journal |
| issn | 1800-6450 1800-7473 |
| language | English |
| last_indexed | 2024-03-13T05:51:25Z |
| publishDate | 2023-06-01 |
| publisher | Center for Quality, Faculty of Engineering, University of Kragujevac, Serbia |
| record_format | Article |
| series | International Journal for Quality Research |
| spelling | doaj.art-f93ac0d175d04b1f8baad1c57c224fef2023-06-13T13:18:48ZengCenter for Quality, Faculty of Engineering, University of Kragujevac, SerbiaInternational Journal for Quality Research1800-64501800-74732023-06-0117255557210.24874/IJQR17.02-16RISK ASSESSMENT IN PET RADIOPHARMACEUTICALS PRODUCTION: PLANNING THE IMPLEMENTATION OF A PRODUCTION LINE COMPLIANT WITH GMP REGULATIONMichela Poli0https://orcid.org/0000-0001-6903-2121Davide Cornolti1https://orcid.org/0000-0002-7667-8825Giorgio Iervasi2https://orcid.org/0000-0001-6805-541XSilvia Pardini3https://orcid.org/0000-0002-6881-484XMauro Quaglierini4https://orcid.org/0000-0001-6253-3150Alessandro Zega5https://orcid.org/0000-0002-4852-7245Debora Petroni6https://orcid.org/0000-0002-6146-666XNational Research Council - Institute of Clinical Physiology, Via Moruzzi 1, Pisa, ItalyNational Research Council - Institute of Clinical Physiology, Via Moruzzi 1, Pisa, ItalyNational Research Council - Institute of Clinical Physiology, Via Moruzzi 1, Pisa, ItalyNational Research Council - Institute of Clinical Physiology, Via Moruzzi 1, Pisa, ItalyNational Research Council - Institute of Clinical Physiology, Via Moruzzi 1, Pisa, ItalyNational Research Council - Institute of Clinical Physiology, Via Moruzzi 1, Pisa, ItalyNational Research Council - Institute of Clinical Physiology, Via Moruzzi 1, Pisa, ItalyThe 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.http://ijqr.net/journal/v17-n2/16.pdfradiopharmaceuticalsrisk assessmentrisk based thinkinggmprisk identification |
| spellingShingle | Michela Poli Davide Cornolti Giorgio Iervasi Silvia Pardini Mauro Quaglierini Alessandro Zega Debora Petroni RISK ASSESSMENT IN PET RADIOPHARMACEUTICALS PRODUCTION: PLANNING THE IMPLEMENTATION OF A PRODUCTION LINE COMPLIANT WITH GMP REGULATION International Journal for Quality Research radiopharmaceuticals risk assessment risk based thinking gmp risk identification |
| title | RISK ASSESSMENT IN PET RADIOPHARMACEUTICALS PRODUCTION: PLANNING THE IMPLEMENTATION OF A PRODUCTION LINE COMPLIANT WITH GMP REGULATION |
| title_full | RISK ASSESSMENT IN PET RADIOPHARMACEUTICALS PRODUCTION: PLANNING THE IMPLEMENTATION OF A PRODUCTION LINE COMPLIANT WITH GMP REGULATION |
| title_fullStr | RISK ASSESSMENT IN PET RADIOPHARMACEUTICALS PRODUCTION: PLANNING THE IMPLEMENTATION OF A PRODUCTION LINE COMPLIANT WITH GMP REGULATION |
| title_full_unstemmed | RISK ASSESSMENT IN PET RADIOPHARMACEUTICALS PRODUCTION: PLANNING THE IMPLEMENTATION OF A PRODUCTION LINE COMPLIANT WITH GMP REGULATION |
| title_short | RISK ASSESSMENT IN PET RADIOPHARMACEUTICALS PRODUCTION: PLANNING THE IMPLEMENTATION OF A PRODUCTION LINE COMPLIANT WITH GMP REGULATION |
| title_sort | risk assessment in pet radiopharmaceuticals production planning the implementation of a production line compliant with gmp regulation |
| topic | radiopharmaceuticals risk assessment risk based thinking gmp risk identification |
| url | http://ijqr.net/journal/v17-n2/16.pdf |
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