Fully describe analytical procedures and conditions of sampling, in the form of a standard operating procedure.
The analytical methods should be specific and adequately sensitive, and preference should be given to chromatographic techniques such as high-performance liquid chromatography (HPLC) or gas chromatography (GC).
Clearly state the criteria for accepting or rejecting assay data in the protocol or study report.
Provide a few examples of chromatographic printouts to demonstrate sensitivity and selectivity of the analytical test methods.
Retain all of the original printouts in case we require them, but do not include every printout in the application.
Related information and guidance
Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev 1/ Corr**) briefly outlines the general requirements for validation and quality control of assay procedures used in biopharmaceutic studies, and refers to other EU guidelines on validation of assay procedures.
