Final method system suitability testing

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],... 

The life scientist interested in the concentration, distribution and speciation of chromium in biological systems is in need of reliable and precise analytical data. These can only be obtained by applying first of all a representative sampling and handling procedure, followed by the correct use of an analytical technique with suitable sensitivity. Finally, the bias of the whole method can be tested by analyzing biological standard reference materials, certified for chromium at comparable levels as the unknowns. 

Where the EPS is large, or is a distributed system, EMC testing of its final build stage might be impractical and/or there may be no standard test methods that are suitable. A wide variety of validation activities are available for use in this Step (see Step 5) depending on the type of EPS and the way it is designed, to support whatever testing is practical (and affordable) to achieve sufficient confidence in the safety risks or risk-reductions achieved by the EPS. 

Concentration Method. The concentration procedure that was developed and evaluated was a RO-Donnan dialysis system (4). The initial objective during method development was to conduct membranescreening tests to evaluate the suitability of various RO and ion-exchange membranes. The four membranes considered for final evaluation on the basis of solute rejection, chlorine stability, and artifact production were the cellulose acetate and FT-30 (Film Tec) RO membranes, the Nafion cation-exchange membrane, and the ION AC MA 3475 anion-exchange membrane. 

The first step is to establish internal specifications then, compare the obtained results with the manufacturer s specifications and, finally, interpret the differences. Within-day and interday reproducibility is the minimum test for routine use. Chromatographic systems should be tested for suitability to the performance criteria of the method on a daily basis before and during routine application. An HPLC system should be tested before... 

It is difficult to find a general test criterion for checking the surface purity of a surfactant solution. The analysis of the time dependence of the surface tension seems to be the most suitable method for this purpose. Typical cases of the time dependence are shown in Fig. 1 starting from the creation of a fresh surface. The surface tension can be measured with the applied method from time t . Case a is typical for dilute surfactant solutions containing very surface active impurities where both the surfactant and the contaminants decrease the surface tension on a similar time scale. In case b the surfactant and the impurities equilibrate on different time scales and the contaminants adsorb slowly in the experimental time window. Finally, curve c shows the case when the contaminated system reaches its equilibrium before to-... 

---