Riassunto
La produzione di radiofarmaci è regolata dalle Norme di Buona Preparazione dei Radiofarmaci per Medicina Nucleare (NBP-MN) [1] che, fissando ben definiti standard qualitativi, richiedono:
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l’esecuzione di test di qualifica e convalida, al fine di valutare l’efficienza funzionale e prestazionale sia degli ambienti sia delle apparecchiature e degli impianti;
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l’implementazione e il mantenimento di un sistema di riqualifica periodica per mantenere lo stato qualificato.
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Bibliografia
Farmacopea Ufficiale della Repubblica Italiana, XII ed. Norme di Buona Preparazione dei Radiofarmaci per Medicina Nucleare
EudraLex — The rules governing medicinal products in the European Union. Volume 4 — EU Guidelines for good manufacturing practices (GMP) for medicinal products for human and veterinary use Annex 15: Qualification and validation (July 2001) http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/v4an15_en.pdf
International Organization for Standardization. ISO 14644 Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness.
International Organization for Standardization. ISO 14644 Cleanrooms and associated controlled environments — Part 2: Specification for testing and monitoring to prove continued compliance with ISO 14644-1
EudraLex — The rules governing medicinal products in the European Union. Volume 4 — EU Guidelines for good manufacturing practices (GMP) for medicinal products for human and veterinary use Annex 1: Manufacture of sterile medicinal products (revision November 2008) http://ec.europa.eu/health/files/eudralex/vol-4/2008_11_25_gmp-an1_en.pdf
EudraLex — The rules governing medicinal products in the European Union. Volume 4 — EU Guidelines for good manufacturing practices (GMP) for medicinal products for human and veterinary use Chapter 3.41: Premises and equipment http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/cap3_en.pdf
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Temperini, S., Paiola, B. (2011). Convalide e qualifiche: attrezzature e impianti. In: La qualità nella preparazione dei radiofarmaci. Imaging & formazione, vol 6. Springer, Milano. https://doi.org/10.1007/978-88-470-2020-7_8
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DOI: https://doi.org/10.1007/978-88-470-2020-7_8
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