Procedure for Method Validation

1 Page 1 GLP 14 – 2019 Page 1 of 9 This publication is available free of charge from: https://doi.org/10.6028/NIST.IR. 8250 GLP 14 Good Laboratory Practice for Procedure for Method Validation 1 Introduction This is the metrology... Open at page → 2 Page 2 GLP 14 – 2019 Page 2 of 9 This publication is available free of charge from: https://doi.org/10.6028/NIST.IR. 8250 4 Operations If the laboratory does not have an appropriate method for a calibration or test, or the test... Open at page → 3 Page 3 GLP 14 – 2019 Page 3 of 9 This publication is available free of charge from: https://doi.org/10.6028/NIST.IR. 8250 4.4.8.4 Method of recording the observations, data to be recorded, data reduction, method of analysis, an... Open at page → 4 Page 4 GLP 14 – 2019 Page 4 of 9 This publication is available free of charge from: https://doi.org/10.6028/NIST.IR. 8250 When changes are made in the validated non- standardized procedures, the influence of such changes must b... Open at page → 5 Page 5 GLP 14 – 2019 Page 5 of 9 This publication is available free of charge from: https://doi.org/10.6028/NIST.IR. 8250 Any applicable specifications and/or tolerances; Evaluation of performance characteristics and summaries;... Open at page → 6 Page 6 GLP 14 – 2019 Page 6 of 9 This publication is available free of charge from: https://doi.org/10.6028/NIST.IR. 8250 Appendix A Evaluation Form for Method Validation Review Procedure Evaluated: _ __________________________... Open at page → 7 Page 7 GLP 14 – 2019 Page 7 of 9 This publication is available free of charge from: https://doi.org/10.6028/NIST.IR. 8250 Method Evaluation Observations Standard Calibrations & Intervals. Calibrations of standards (and equipmen... Open at page → 8 Page 8 GLP 14 – 2019 Page 8 of 9 This publication is available free of charge from: https://doi.org/10.6028/NIST.IR. 8250 Method Evaluation Observations Evaluation of Precision. How was data for repeatability obtained? Describe... Open at page → 9 Page 9 GLP 14 – 2019 Page 9 of 9 This publication is available free of charge from: https://doi.org/10.6028/NIST.IR. 8250 Appendix B Example Outline for a Standard Operating Procedure (Title) 1 Scope and Measurand(s) of Calibra... Open at page → 10 Page 10 This page is intentionally blank. This publication is available free of charge from: https://doi.org/10.6028/NIST.IR.8250 Open at page →