Good laboratory practice (GLP) regulations were finally proposed in 1976, being method validation an important part of GLP.
They would eventually publish standards for measurement the performance of laboratories and enforcement policy. created working groups to ensure the validity and reliability of the studies.
Since then, several agencies like United States Food and Drug Administration (FDA), the International Conference for Harmonization (ICH), the United States Pharmacopeia (USP), the International Standards Organization (ISO/IEC), etc.
Most of the information required to evaluate uncertainty can be obtained during validation of the method. Uncertainty should be evaluated and quoted in a way that is widely recognized, internally consistent and easy to interpret. Thus the method performance must be validated and the uncertainty on the result, at a given level of confidence, estimated. For an analytical result to be fit for its intended purpose it must be sufficiently reliable that any decision based on it can be taken with confidence. Method validation enables chemists to demonstrate that a method is “fit for purpose”. Implicit in this is that the tests carried out are appropriate for the analytical part of the problem that the client wishes solved, and that the final report presents the analytical data in such a way that the client can readily understand it and draw appropriate conclusions. Thus, the laboratory and its staff have a clear responsibility to justify the clients trust by providing the right answer to the analytical part of the problem, in other words, results that have demonstrable “fitness for purpose”’. The client expects to be able to trust the results reported. When a client commissions analytical work from a laboratory, it is assumed that the laboratory has a degree of expertise that the client does not have. If the result of a test cannot be trusted then it has little value and the test might as well have not been carried out.
Data inconsistencies and evidence of unacceptable laboratory practices came to light. Suspicion about this assumption was raised during the review of some studies. Until the 1970´s, the underlying assumption was that the reports submitted by laboratories accurately described study conduct and precisely reported the study data. Virtually every aspect of society is supported in some way by analytical measurement, consequently, there is a need these analyses would be reliable.
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Any year, millions of analyses of any kind are performed around the world, and millions of decisions are made, based on these analyses have the medicaments, the amount of drug reported in their container?, Can we safely consume this water or these foods?, are these alloys suitable for use in the aircraft construction?, was the driver drunk, when he crashed?, is this sportsman using drugs to enhance his performance?, and if he was punished, there is no doubt, he was using those substances or we are unfair with him all these questions are answered with the help of a chemical analysis and all have consequences in real life (compensation claims, disease, fines, even prison).
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