Guidelines for the Development and Validation of Near-infrared Spectroscopic Methods in the Pharmaceutical Industry
2006
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
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References
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Citations
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KQI