Validation radiopharmaceuticals preparation

The same GMP guidelines are, where relevant, valid for the preparation of radiopharmaceuticals in hospitals. Some national competent authorities have issued detailed regulations about what has to be considered. Detailed requirements such as ... 

Several European centers were engaged in implementing GMP standards for the preparation of " Tc radiopharmaceuticals in nuclear medicine, and thus have contributed to establish a protocol for analytical procedures, which can validate the performance of generator systems from different manufacturers and assure the quality of short-lived generator eluates. The protocol is presented in Appendix A1 of this chapter. 

Aseptic National Preparation in class A background preparation guideline class D At each batch extent depending on risk assessment Environmental monitoring Depending on characteristics radiochemical/ radiopharmaceutical validation of labelling limited product dossier... 

In some situations, for example with very short-lived radiopharmaceuticals, conditional release before all QC tests are performed is necessary. As a consequence, process validation is important An immediate recall procedure must take place, when product quality is found to be insufficient Stock preparations usually undergo an extensive analytical control (see Sect. 34.9.2) and remain in quarantine until the QC is fuUy completed (see Sect. 34.9). The release is based on the assessment of the document control in combination with the analytical quality controls. During release, final reconciliation takes place. For certain preparations (e.g. aseptic preparations) also the results of monitoring of production conditions are included. 

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