Guidelines for the Development and Validation of Near-infrared Spectroscopic Methods in the Pharmaceutical Industry

The sections in this article are Preface Introduction Background and Purpose Overview Types of Near-Infrared Procedures to be Validated Validation Requirements Equipment Equipment Selection Equipment Qualification Design Qualification Installation Qualification Operational Qualification Performance Qualification Change Control Hardware Software Glossary References Books Useful Reference Journals Useful Papers Technical Guidelines for Qualitative Methods Introduction to Qualitative Analysis Feasibility Study Sample Authentication, Collection and Measurement Sample Measurement/Presentation Measurement by Transmission Liquids and Solutions Solids Measurement by Diffuse Reflection Measurement by Transflection Library Development Define the Purpose Selection of Samples/Spectra for Calibration Set Display Data Calibration Set Selection Data Pre-Processing/Transformation Library Construction Determination of Thresholds Library Validation Internal and External Validation Internal External Specificity Repeatability Robustness Routine Use Out-of-Specification Results Library Maintenance Database Material Groupings New Materials Addition Material “Library Group” Modification Technical Guidelines for Quantitative Methods Introduction to Quantitative Analysis Feasibility Study Sample Collection Sample Scanning Displaying and Checking Spectra Reference Data Sample Selection – Calibration and Calibration Test Sets Data Pre-Processing Generation of Calibration Model Validation of Calibration Model Performance Verification Accuracy Monitoring Use of a Check Sample Comparison with Reference Method Maintenance of the Calibration Model Method Transfer Acknowledgments