FAM Expert Review Panel (ERP) Training

SLV Protocol Format

1. Title – includes name of method, mode of measurement, analyte(s), matrix(es), analytical technique, and type of study (SLV) 2. Authors - Sponsor(s)/Technical Consultant/Coordinating Laboratory 3. Introduction a. Method principle and description b. Validation overview and scope i. Relevant Guidelines ii. Relevant SMPR(s) iii. Scope of validation [matrix(es), test materials, reference materials]

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SLV Protocol Format

4. Good Laboratory Practices a. Randomizing/blind coding b. Safety precautions 5. Definitions 6. Reference Materials, reference standards, reference methods – identify and provide source or link. 7. Validation studies – identify where the studies will be performed and provide a specific study design and protocol for each study a. Selectivity b. Calibration model

c. Matrix Study d. Robustness

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