Standard operating procedures final method

The method must be evaluated against predefined acceptance criteria one parameter at a time or simultaneously as part of a design of experiment (DoE) approach (http //www.sigmaplus.fr). By identifying the parameters that are critical to the performance of the method, a range of values can be incorporated in the final version of the standard operating procedure or method ... 

Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the nonclinical laboratory study. 

Three control methods are used on each bead-end system. First, the poison is mixed according to standard operating procedures and the measurements are affirmed by the operator s supervisor. Second, the poisoned solution is stirred, sampled, analyzed, and the analysis reported while still in the mix tank, Finally, a Nuclear Poison Detection System (NPDS) must show an acceptable poison concentration before the solution can be transferred. The NPDS provides a continuous monitoring of the boron concentration in the solution and automatic alarm and shutoff of the acid feed valves should the... 

Other direct serum cholesterol techniques have been modified for the AutoAnalyzer. Several investigators have adapted the procedure of Pearson et al. (PI, P2), which is based on the use of glacial acetic, p-toluenesulfonic, and sulfuric acids. The several advantages cited by proponents of this technique include simplicity and speed of operation compared to extraction methods, which are time-consuming and require considerable manipulative skill greater specificity of the Pearson vs. Zlatkis techniques stability of the final color and similarity of absorbances of both free and esterified cholesterol. A disadvantage of the direct methods is that standards in organic solvents do not exhibit the... 

CRMs to finalise the method development, to validate analytical procedures and finally control in time the accuracy of procedures, are rare and valuable materials, in particular matrix CRMs. They should tell the analyst how his entire measurement procedure is performing. He will receive information on precision as well as on trueness. CRMs are primarily developed to check for trueness, which is the most difficult property to verify. Precision can be tested on RMs or can be estimated from published data e.g. the performance required by a standard method, whereas the evaluation of trueness is possible only with external help a CRM or a properly organised interlaboratory study. Having a CRM allows one to perform the verification of trueness whenever the operator wants it. The analyst should never forget that only when accurate results (precise and true) are achieved, comparability in space and over time is guaranteed. But to exploit to a maximum the information on trueness delivered by the CRM, the precision must also be sufficient and verified. 

If methods are used in which the overall recovery is 70% or above, and if the possibility of accidental but undetected very large losses is reduced by using a minimum of steps and transfer operations, or by automation, it is questionable whether in practice the precision will be greatly increased by current techniques of using internal radioactive standards. In the case of many urinaiy steroids, conjugated internal standards would be required for full control of the procedure and are not yet generally available. Finally the technique itself is not error-free, even in the absence of isotope effects, and the usual techniques employed so far often involve very small volumes of volatile solvents in which transfer errors can be large unless very superior manual technique is used. 

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