GMP in Radiopharmacy: the current situation in its context

Hendrikus Boersma

doi:10.1016/B978-0-12-822960-6.00188-5

GMP in Radiopharmacy: the current situation in its context

Hendrikus Boersma

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Abstract

Over the last decades, Good Manufacturing Practice (GMP) has evolved from a kind of uncomfortable requirement to an
indispensable tool for the production and quality control of state of the art pharmaceuticals. Somewhat later than regular pharmacy,
also radiopharmacy was encouraged to comply with GMP. The short version of this story, is that this was not a straightforward
process. For example, in the year 2000, it was still a common opinion that GMP for the radiopharmacy could consist of a kind of
“light version” compared to the GMP regulations used within the pharmaceutical industry. As the involvement of Inspectorates and
Industries in Radiopharmacy increased, GMP was there to stay. And, as we will see in this chapter, not in a kind of “light version.”
The aim of this chapter is to give a concise overview on radiopharmaceutical GMP. Furthermore, some future perspectives are
provided to point out where it may lead us.

Original language	English
Title of host publication	Nuclear Medicine and Molecular Imaging
Subtitle of host publication	Basic concepts, radiopharmacy and instrumentation
Place of Publication	New York
Publisher	Elsevier
Pages	243-249
Number of pages	5
Volume	1
Edition	1
ISBN (Electronic)	978-0-12-822980-4
ISBN (Print)	978-0-12-822980-4
DOIs	https://doi.org/10.1016/B978-0-12-822960-6.00188-5
Publication status	Published - 13-Jul-2022

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GMP in radiopharmacyFinal publisher's version, 1.85 MBLicence: Taverne

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abstract = "Over the last decades, Good Manufacturing Practice (GMP) has evolved from a kind of uncomfortable requirement to an indispensable tool for the production and quality control of state of the art pharmaceuticals. Somewhat later than regular pharmacy, also radiopharmacy was encouraged to comply with GMP. The short version of this story, is that this was not a straightforward process. For example, in the year 2000, it was still a common opinion that GMP for the radiopharmacy could consist of a kind of “light version” compared to the GMP regulations used within the pharmaceutical industry. As the involvement of Inspectorates and Industries in Radiopharmacy increased, GMP was there to stay. And, as we will see in this chapter, not in a kind of “light version.” The aim of this chapter is to give a concise overview on radiopharmaceutical GMP. Furthermore, some future perspectives are provided to point out where it may lead us.",

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GMP in Radiopharmacy: the current situation in its context

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