Abstract
BackgroundTo fulfil good manufacturing requirements, analytical methods for the analysis of pharmaceuticals for human and vetinary use must be validated. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has published guidance documents on the requirements for such validation activities and these have been adopted by the European Medicines Agency, The U.S. Food and Drug Administration (FDA) and other regulatory bodies. These guidance documents do not, however, fully address all the specific tests required for the analysis of radiopharmaceuticals. This guideline attempts to rectify this shortcoming, by recommending approaches to validate such methods.ResultsRecommedations for the validation of analytical methods which are specific for radiopharmaceutials are presented in this guideline, along with two practical examples.ConclusionsIn order to comply with good manufacturing practice, analytical methods for radiopharmaceuticals for human use should be validated.
Highlights
To fulfil good manufacturing requirements, analytical methods for the analysis of pharmaceuticals for human and vetinary use must be validated
The validation results have demonstrated that the method is acceptable with respect to the various test parameters and fit for purpose
It should be noted that the validated radioactivity concentration range should be taken into account when performing stability studies
Summary
To fulfil good manufacturing requirements, analytical methods for the analysis of pharmaceuticals for human and vetinary use must be validated. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has published guidance documents on the requirements for such validation activities and these have been adopted by the European Medicines Agency, The U.S Food and Drug Administration (FDA) and other regulatory bodies. Radiopharmaceutical preparations or radiopharmaceuticals (RPs) are medicinal products which, when ready for use, contain one or more radionuclides included for a medical purpose. [18F]fluorodeoxyglucose) or large molecules (e.g. 125I-labelled human serum albumin) as the active pharmaceutical ingredient. The principal radioactive ingredient may be characterised and quantified on the basis of the chemistry of the molecule and the physical properties of the radionuclide. Radionuclides used in the field of molecular imaging and therapy may have half-lives in the range of seconds to hundreds of days
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