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The 1MP provides the validation of the entire process following the GMP requirement and the previous customised VMP:
Analytical method: the objective is to demonstrate the suitability for the intended purpose. Results from method validation can be used to establish the quality and the reliability of analytical results.
Suppliers and Raw materials
Cleaning validation: the objective is to demonstrate that the adopted cleaning procedure is effective in removing the product and solvent residue to demonstrate the prevention of cross-contamination in production.
Process validation: the objective is to demonstrate that [18F] FDG, using pre-qualified equipment and materials, can be manufactured consistently to the required product specification.