The role of quality management system in the monitoring and continuous improvement of GMP-regulated short-lived radiopharmaceutical manufacture

The last decade has seen extraordinary growth in the clinical use of Positron Emission Tomography (PET), an in vivo molecular imaging modality widely used in oncology that requires the use of radiopharmaceuticals labeled with short-lived radionuclides. These medicinal products have found widespread...

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Veröffentlicht in:	Accreditation and quality assurance 2014-10, Vol.19 (5), p.343-354
Hauptverfasser:	Poli, M., Petroni, D., Berton, A., Campani, E., Felicini, C., Pardini, S., Menichetti, L., Salvadori, P. A.
Format:	Artikel
Sprache:	eng
Schlagworte:	Analytical Chemistry Biochemistry Chemistry Chemistry and Materials Science Commercial Law Continuous improvement Data analysis Ecotoxicology Fluorides Food Science Good Manufacturing Practice In vivo methods and tests ISO standards Manufacturing Marketing Nuclear medicine Pharmaceuticals Positron emission Practitioner's Report Principles Quality management Radiation Radiochemical analysis Radioisotopes
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