Draft Guideline on Bioanalytical Method Validation in ... - NIHS

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storage), record of analyses, record of instrument (calibration and settings), record of
deviations, record of communications, and raw data such as analytical data and
chromatograms.
Validation report
Summary of the validation
Information on the reference standards
Information on the blank matrices
Analytical method
Validated parameters and the acceptance criteria
Validation results and discussion
Rejected runs together with the reason for rejection
Information on reanalysis
Deviations from the protocol and/or SOP, along with the impact on study results
Information on reference study, protocol, and literature
Representative chromatograms
Study sample analysis report
Summary of the study sample analysis
Information on the reference standards
Information on the blank matrices
Information on receipt and storage of study samples
Analytical method
Parameters, acceptance criteria, and results of the validity evaluation
Results and discussion of study sample analysis
Rejected runs together with the reason for rejection
Information on reanalysis
Deviations from the protocol and/or SOP, along with impact on study results
Information on reference study, protocol, and literature
Representative chromatograms, as needed
List of relevant guidelines
1) Regarding "the Guidance on Nonclinical Safety Studies for the Conduct of Human
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