COMPONENTS OF DATA QUALITY
There are four critical components involved in the generation of reliable and consistent data (quality data). Figure 1 shows these components as layered activities within a quality triangle. Each layer adds to the overall quality. Analytical instrument qualification forms the base for generating quality data. The other components essential for generating quality data are analytical method validation, system suitability tests, and quality control check samples. These quality components are described below.
AIQ is the collection of documented evidence that an instrument performs suitably for its intended purpose. Use of a qualified instrument in analyses contributes to confidence in the validity of generated data.
Analytical Method Validation
Analytical method validation is the collection of documented evidence that an analytical procedure is suitable for its intended use. Use of a validated procedure with qualified analytical instruments provides confidence that the procedure will generate test data of acceptable quality. Additional guidance on validation of compendial procedures may be found in the general information chapter Validation of Compendial Procedures 1225 .
System Suitability Tests
System suitability tests verify that the system will perform in accordance with the criteria set forth in the procedure. These tests are performed along with the sample analyses to ensure that the system's performance is acceptable at the time of the test. USP general chapter Chromatography 621 presents a more detailed discussion of system suitability tests as related to chromatographic systems.
Quality Control Check Samples
Many analysts carry out their tests on instruments standardized using reference materials and/or calibration standards. Some analyses also require the inclusion of quality control check samples to provide an in-process or ongoing assurance of the test's suitable performance. In this manner, AIQ and analytical method validation contribute to the quality of analysis before analysts conduct the tests. System suitability tests and quality control checks help ensure the quality of analytical results immediately before or during sample analysis.