Guidance on current good radiopharmacy practice for the small-scale preparation of radiopharmaceuticals using automated modules: a European perspective-Reference-Cited by-同舟云学术

Guidance on current good radiopharmacy practice for the small-scale preparation of radiopharmaceuticals using automated modules: a European perspective

Published:2014-08 Issue:10 Volume:57 Page:615-620
ISSN:0362-4803
Container-title:Journal of Labelled Compounds and Radiopharmaceuticals
language:en
Short-container-title:J. Label Compd. Radiopharm

Author:

Aerts Joel¹²,Ballinger James R.³,Behe Martin⁴,Decristoforo Clemens⁵,Elsinga Philip H.⁶,Faivre-Chauvet Alain⁷,Mindt Thomas L.⁸,Kolenc Peitl Petra⁹,Todde Sergio C.¹⁰,Koziorowski Jacek¹¹

Affiliation:

1. University of Liege; 4000 Liege Belgium

2. University of Paris VII Diderot; 75018 Paris France

3. Guy's and St Thomas' Hospital; London SE1 9RT UK

4. ETH-PSI-USZ Paul-Scherrer-Institute; 5232 Villigen-PSI Switzerland

5. Innsbruck Medical University; 6020 Innsbruck Austria

6. University Medical Center; University of Groningen; 9700 RB Groningen Netherlands

7. CHU de Nantes; 44093 Nantes France

8. University Hospital Basel; 4031 Basel Switzerland

9. University Medical Centre Ljubljana; 1000 Ljubljana Slovenia

10. Università di Milano-Bicocca; 20052 Monza Italy

11. Universitetssjukhuset; 581 85 Linköping Sweden

Publisher

Wiley

Subject

Organic Chemistry,Spectroscopy,Drug Discovery,Radiology Nuclear Medicine and imaging,Biochemistry,Analytical Chemistry

Reference7 articles.

1. European Association of Nuclear Medicine Radiopharmacy Committee Guidelines on current good radiopharmacy practice (cGRPP) in the preparation of radiopharmaceuticals, version 2 2007 http://www.eanm.org/publications/guidelines/gl_radioph_cgrpp.pdf

2. Guidance on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals

3. Pharmaceutical Inspection Co-operation Scheme Document PI 006-3: Recommendations on validation master plan, installation and operational qualification, non-sterile process validation, cleaning validation 2007 http://www.picscheme.org/pdf/25_pi-006-3-recommendation-on-validation-master-plan.pdf

4. Pharmaceutical Inspection Co-operation Scheme Document PE 010-4, Annex 3: Good practices for the preparation of radiopharmaceuticals in healthcare establishments 2014 http://www.picscheme.org/bo/commun/upload/document/pe-010-4-guide-to-good-practices-for-the-preparation-of-medicinal-products-in-healthcare-establishments-1.pdf

5. European Commission Eudralex Volume 4 Good manufacturing practice (GMP) guidelines. Annex 15: Qualification and validation 2001 http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/v4an15_en.pdf

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