Introduction
Virtually every aspect of society is supported in some way by analytical measurement. There are innumerable reasons for making these measurements, for example: in-process and final inspection or ‘quality control’ of manufactured products; supporting healthcare; checking the quality of drinking water; metallurgical analysis of an alloy to confirm its suitability for use in aircraft construction; forensic analysis of body fluids in criminal investigations.
The cost of carrying out these measurements is huge cost implications arise from decisions made on the basis of the results. Analytical results may be used in evidence and challenged in a court of law: tests showing food to be unfit for consumption my result in compensation claims; test confirming the presence of banned drugs could result in fines, imprisonment or even, in some countries, execution. Clearly it is important to determine the correct result and be able to show that it is correct.
Method validation is the process of defining an analytical requirement, and confirms that the method under consideration has performance capabilities consistent with what the application requires.
Contents of the Guide
- Introduction
- What is Method Validation?
- When should Methods be Validated?
- Method Development
- The Essential Components of Method Validation
- Selectivity and Specificity
- Limit of Detection
- Limit of Quantitation
- Working & Linear Ranges
- Accuracy
- Precision
- Repeatability
- Reproducibility
- Measurement Uncertainty
- Sensitivity
- Ruggedness (or Robustness)
- Recovery
- The Validation Tools
- Appendix