System Suitability Testing SST

Repeatability (RSD) of peak response f.0% for five replicates f.5% general 5-15% for trace 5% for biologies 

If initial SST fails, the analyst should stop the sequence immediately, diagnose the problem, make necessary adjustments or repairs, and re-perform SST. Analysis of actual samples should commence only after passing all SST limits, not only the failed criteria. Most SST failures are traced to problems from the autosampler, pump, column, or mobile phase (see Chapter 10 on troubleshooting hints). If one of the interspersed SSS injections fails, data from all samples after the last passing SSS become invalid and must be repeated.15 

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In Phase III, the final dosage formulation has been established and the pivotal clinical trials are being conducted. Degradation products have been identified, so the method selectivity should be reevaluated to ensure that all degradants can be detected and quantitated. The analytical methods are completely validated, and appropriate for routine quality assurance and control purposes. The type and frequency of system suitable testing (SST) should be determined, and an excellent publication on SST for chromatography systems is available [47],... 

There are four general steps to ensure this control and consequently to guarantee the data quality [32] quality control checks (QC), system suitability tests (SSTs), analytical methods validation (AMV), and analytical instrument qualification (AIQ) (see Figure 5). 

At least initial qualification and system suitability Testing (SST) or periodic retest (PR)... 

ISO defines validation as Conformation by examination and provision of objective evidence that the particular requirements for a specified intended use are fulfilled. This is decided by using a number of performance characteristics. These are specificity, linearity, range, accuracy, precision, detection limit (DL), quantitation limit (QL), and robusmess. System suitability testing (SST) is an integral part of many analytical procedures. Definitions of these terms based on the recommendations of the ICH Guideline Q2 (Rl) are given in Table... 

The responses of main interest also are different in method development and robustness testing. In development, the considered responses are related to the quality of the separation (l),such as, for electrophoretic methods, migration times, peak shapes, and the resolutions between neighboring peaks. When the separation is optimized and the method is validated, thus also in robustness testing, the responses of main interest are related to the quantitative aspects of the method, such as contents, concentrations, or recoveries. The responses considered during development occasionally are considered in a second instance, for example, as system suitability test (SST) parameters. 

The simplest and safest method for an equipment check is a double injection with a known, stable sample, (control sample. System Suitability Test SST). If the resulting chromatograms are identical with a reference chromatogram which you obtained with the equipment in perfect condition - maybe after a scheduled master check - there is no need for further checks. You know that everything works well (method plus equipment). As criteria for the comparison, you could use retention time, peak area, peak height and asymmetry. Acceptable deviations are to be documented. 

Analysis sequence table with details about vial positions, sample name, standards, system suitability testing (SST) solutions, sample type, calibration information, sample volume, dilution factor, injection volume, method ID Instrument method with information on flow rate, mobile phase composition, injection volume, column temperature (1 1 compilation of the testing instructions)... 

All samples in the autosampler of the HPLC are listed exactly in the order of the analysis sequence and include system suitability tests (SSTs) and calibration samples. 

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