HHE Radiology and imaging supplement 2018 | Page 17
radiology and imaging
Ensuring safety
in nuclear medicine
Hospital Healthcare Europe spoke with Jilly Croasdale of the UK Radiopharmacy Group about
guidance on safe drawing up of radiopharmaceuticals in nuclear medicine departments
Jilly Croasdale
Head of Radiopharmacy;
and Associate Director,
Healthcare Science,
Sandwell and West
Birmingham Hospitals
NHS Trust, UK
EU good manufacturing practice (GMP) relates
to the manufacture of medicines, and in
radiopharmacy this can be a challenge in some
ways. Because the products have to be used
immediately, it is not possible to perform all the
usual end product testing that you would with
other types of products. For example, sterility
testing is done retrospectively, and, because the
batch size is often one, it is not possible to
sterility test each batch produced (or there may
be nothing left to administer to the patients).
However, wherever possible, manufacture will
conform to the regulatory requirements, and because
of the need to often use radiopharmaceuticals
immediately, there is particular emphasis on quality
assurance of the process, in order to ensure the
products made are fit for patient use.
17
HHE 2018 | hospitalhealthcare.com
Once the radiopharmaceutical has been released
for use, further manipulations of the product to
enable administration do not come within the
remit of GMP. However, it is important that their
handling does not pose a risk to patients.
How does the guideline relate to kits?
The Safe Drawing Up Document 1 relates to how
radiopharmaceuticals presented as multi-dose
vials are handled in the nuclear medicine
department. Although GMP does not directly
apply, it should be remembered that the purpose
of GMP is to make sure medicines are safe for use
in patients. The manufacture of these is just one
aspect – obviously how they are stored and used
also has a considerable impact.
The Safe Drawing Up document therefore