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Revised guidance for elaborating monographs on radiopharmaceutical preparations: new section on validation of methods

European Pharmacopoeia
14 January 2019
Strasbourg, France


Monographs and general texts on radiopharmaceutical preparations are elaborated by experts in the field. In order to guide experts on the information to be included in European Pharmacopoeia (Ph. Eur.) monographs, and also to harmonise the style of the different monographs, a Guide for the elaboration of monographs on radiopharmaceuticals was published by the EDQM in 2010. This Guide has now been updated to include a section on the validation of methods used in the analysis of radiopharmaceuticals, reflecting the validation requirements applicable to analytical methods included in Ph. Eur. monographs. The new validation section in the revised Guide is the result of a joint effort by Ph. Eur. experts on radiopharmaceuticals and the members of the European Association of Nuclear Medicine’s (EANM) Radiopharmacy Committee.

In the course of method development for the quality control of active pharmaceutical ingredients in non-radioactive, “traditional” chemicals, validation of analytical methods according to ICH Q2 (R1)1 has been an integral part of the process for decades. In the field of radiopharmaceutical preparations, commercial manufacturers have been performing validation activities for a long time, whereas small producers sometimes face difficulties in preparing validation protocols. This is mainly due to the fact that the evaluation of the validation characteristics must be adapted to the special case of radiopharmaceuticals: the short half-life of the radionuclides, non-availability of radiochemical impurities and radiation protection need to be considered in the study design. The Guide gives in-depth guidance on the evaluation of validation characteristics adapted to radioactive compounds. It is designed by and for Ph. Eur. experts responsible for elaborating and revising monographs on radiopharmaceuticals, but it can also serve as a useful guidance document for other parties interested in the quality control of radiopharmaceuticals.

Access here the Guide for the elaboration of monographs on radiopharmaceuticals.

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