Monographs on radiopharmaceutical preparations - Revised Guideline

Recommendation

7/8 May 2024

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Regulatory Requirements and Practical Implementation

For the preparation of monographs in the European pharmacopoeias and other texts for pharmaceuticals, experts are consulted in appropriate working groups. This also applies to the relevant documents for radiopharmaceutical preparations. In doing so, value is placed on the uniform and harmonized design of the monographs. In order to provide the experts in the working groups with a guideline, the EDQM published a guideline for the preparation of monographs on radiopharmaceuticals in 2010.

This document has now been updated to include a section on the validation of methods used in the analysis of radiopharmaceuticals. This reflects the validation requirements for analytical methods as required in the EP. In the context of method development for quality control of active pharmaceutical ingredients in non-radioactive "traditional" chemicals, the validation of analytical methods according to "ICH Q2 (R1)1 Validation of Analytical Procedures: Text and Methodology - International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use" has been an integral part of the process for decades. Such validations are usually already carried out, especially by commercial and thus often larger manufacturers. For smaller manufacturers in particular, the corresponding validation, the creation of validation protocols and other documentation presents a major challenge. This is mainly due to the special characteristics of many radiopharmaceutical preparations, which require an adaptation of the validation characteristics. The short half-life of radionuclides, the non-availability of radiochemical impurities and radiation protection must be taken into account in the study design.

The new validation section in the revised guideline is the result of a joint work by Ph. Eur. Radiopharmaceuticals experts and members of the Radiopharmacy Committee of the European Association for Nuclear Medicine (EANM). The document now contains detailed guidance on the adapted assessment of validation characteristics taking into account radiopharmaceutical specificities. It has been prepared by and for Ph. experts responsible for the preparation and revision of monographs on radiopharmaceuticals, but can also serve as a useful guide for other parties interested in the quality control of radiopharmaceuticals.

For further information, please read the public notice of the EDQM Revised guidance for elaborating monographs on radiopharmaceutical preparations: new section on validation of methods.