Abstract
Manufacturers of medicinal products including radiopharmaceuticals have to follow regulations from their governmental organizations as well as professional societies to ensure built-in quality combined with patient safety issues. This chapter is a concise review of Good Manufacturing Practices (GMP) with a special focus on the production of radiopharmaceuticals. Furthermore, attention is given to the added value of GMP as a tool for providing more insights and awareness. Working under GMP conditions leads to potentially faster problem solving in daily practice, as compared to the “skills-only”-based approach. The latter had been a mainstay for a long time but is being more and more replaced by a “skills-based and oversight approach” nowadays.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Decristoforo C, Peňnuelas I. Towards a harmonized radiopharmaceutical regulatory framework in Europe? Q J Nucl Med Mol Imaging. 2005;53:394–401.
Duatti A, Bhonsle U. Strengthening radiopharmacy practice in IAEA member states. Semin Nucl Med. 2013;43:188–94.
Elsinga P, Todde S, Penuelas I, Meyer G, Farstad B, Faivre-Chauvet A, Mikolajczak R, Wester G, Gmeiner-Stopar T, Decristoforo C. Guidance on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals. Eur J Nucl Med Mol Imaging. 2010;37:1049–62.
EMA website (Good-manufacturing-practice and good-distribution-practice compliance). http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/documentlisting_000154.jsp. Website visited Oct 2014.
Eudralex – volume 4. Good manufacturing practice (GMP) Guidelines. European Commission. http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm. Website visited Oct 2014.
Guidelines on current good radiopharmacy practice (cGRPP) in the preparation of radiopharmaceuticals. cGRPP-guidelines version 2, march 2007. http://www.eanm.org/publications/guidelines/gl_radioph_cgrpp.pdf. Website visited Oct 2014.
IAEA. Operational guidance on hospital radiopharmacy a safe and effective approach. International Atomic Energy Agency; 2008, ISBN 9201067089, 9789201067081.
PIC/S. Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme: PIC/S guide to good practices for the preparation of medicinal products in healthcare establishments – PE 010-1 Into force on 1 Oct 2008. http://www.picscheme.org/pdf/23_pe0103-revisedgppguide.pdf.
Poli M, Petroni D, Pardini S, Salvadori PA, Menichetti L. Implementation of a quality assurance system according to GMP and ISO 9001:2008 standard for radiopharmaceutical production in a public research centre. Accred Qual Assur. 2012;17:341–8.
WHO-GMP. WHO good manufacturing practices for pharmaceutical products: main principles. In: WHO Expert Committee on specifications for pharmaceutical preparations. Forty-eighth report. Geneva: World Health Organization; 2014, Annex 2 (WHO Technical Report Series, No. 986).
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2017 Springer International Publishing Switzerland
About this chapter
Cite this chapter
Gerrits, E., Woerdenbag, H.J., Luurtsema, G., Hooge, M.N.Ld., Boersma, H.H. (2017). The Added Value of Good Manufacturing Practices (GMP) in the Production of Radiopharmaceuticals. In: Glaudemans, A., Medema, J., van Zanten, A., Dierckx, R., Ahaus, C. (eds) Quality in Nuclear Medicine. Springer, Cham. https://doi.org/10.1007/978-3-319-33531-5_3
Download citation
DOI: https://doi.org/10.1007/978-3-319-33531-5_3
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-33529-2
Online ISBN: 978-3-319-33531-5
eBook Packages: MedicineMedicine (R0)