Test procedures three criteria

Some would say that this is the current state of the art. Much of the necessary library could be assembled from test systems that have been extensively evaluated and have already undergone extensive validation (Gad, 2000, 2001). Three critical steps must be taken for the eventual fulfillment of these objectives (1) acceptance of a scientific approach to the problem of safety assessment (2) development of an operative validation and acceptance process for new test procedures (3) clear enunciation of an acceptance criterion for new test designs by regulatory authorities. 

DPE suits, and butyl rubber (NRC, 2001b). The levels were 0.0002 to 0.0008 ng/m3, three orders of magnitude below the EPA criterion of 0.2 ng/m3 for dioxin emissions from incinerators. In the test with neat GB, the product gas contained 0.01 to 0.06 percent phosphine. As noted previously in the section on methods development testing, phosphine can interfere with the measurement of GB. Based on results from the EPA s toxicity characteristic leachate procedure, stabilization would be necessary only for solid wastes derived from DPE suit material, because the cadmium and lead criteria were not met by the treated dunnage in some tests (NRC, 2001b). 

In two of the three plant examples, LVE s were run simultaneously with CAM or PCAM equipment for purposes of establishing equivalency according to the OSHA criterion and according to more detailed procedures given in the "Protocol Paper" C2.). CAM/LVE equivalency was demonstrated in both these cases. It was not possible to use LVE s in the third test. 

For each dmg substance, the maximum acceptable levels of the various impurities are described in the drug substance monograph or the specification included in the submissions to the regulatory authorities. In this chapter, the ICH Q6A [4] and Q6B [5] definition of specification is used. A specification consists of three parts the test (e.g. moisture content, impurities), references to the analytical procedure (e.g. high-performance liquid chromatography [HPLC], gas chromatography [GC]), and the acceptance criterion (e.g. not more than 0.50%). 

The /-test is widely used in analytical laboratories for comparing samples and methods of analysis. Its application, however, relies on three basic assumptions. Firstly, it is assumed that the samples analysed are selected at random. This condition is met in most cases by careful design of the sampling procedure. The second assumption is that the parent populations from which the samples are taken are normally distributed. Fortunately, departure from normality rarely causes serious problems providing sufficient samples are analysed. Finally, the third assumption is that the population variances are equal. If this last criterion is not valid then errors may arise in applying the /-test and this assumption should be checked before other tests are applied. The equality of variances can be examined by application of the F-test. 

All three tests are required and each test condition is to be performed independently. The sample size, pre-conditioning, and inspection procedure are also defined in this test method. As of this writing, no industry standard is yet available for the acceptance criterion for tin whiskers. Acceptance criteria have been proposed by several industry consortia (for example, whisker length <40 7 pm depending on product category), and some component vendors have proposed the maximum whisker length of 50 pm after two years of storage as the criterion. 

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