Journal of Developing Drugs

Journal of Developing Drugs
Open Access

ISSN: 2329-6631

+44 1478 350008

Sterile/Aseptic manufacturing: Additional challenges in production of radiopharmaceuticals


3rd International Summit on GMP, GCP & Quality Control

September 25-26, 2014 Valencia Convention Centre, Spain

Valentina Ferrari

Accepted Abstracts: J Dev Drugs

Abstract :

The manufacturing of radiopharmaceutical products adds a lot of challenges to the manufacturing facilities due to the uniqueness of these products. With these products it is very challenging to follow the requirements of quality guidelines and still be in compliance with the standards of staff safety and radiation protection. In addition, the short shelf life requires fast transportation and administration to the patient compared to non-radioactive products. This means thatsome of the classical requirements like sterility testing and environmental monitoring before release cannot be fulfilled.This compromise is accepted as long as appropriate safely measures are taken by the manufacturer to ensure the highest standards are being applied to the processes to ensure the products are suitable for their use.

Biography :

Valentina Ferrari is a Pharmaceutical Chemist. She has completed her PhD on Pharmaceutical Sciences and Bioactive Compounds at the University of Pisa and after working as a Pharmacist for a while, she has started her career in GMP Manufacturing of Radiopharmaceuticals in 2008. She has worked at the Institute of Clinical Physiology in Pisa for 3 years in Manufacturing and Quality Control of Radiopharmaceuticals and then moved to Cambridge to the Wolfson Brain Imaging Centre, another GMP facility specialized in the Manufacturing of Radiopharmaceuticals where she?s been for 5 years. She?s now a Qualified Person at GE Healthcare in Amersham.

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