Methods in validating tests
Methods in validating tests - most popular senior dating sites
The scope of the method and its validation criteria should be defined early in the process.These include the following questions: The method’s performance characteristics should be based on the intended use of the method.
Possible steps for a complete method validation are listed in Table 1.
The validation procedure in this particular article is based on requirements for EU multistate registration.
Wegscheider (13) has published procedures for method validation with a special focus on calibration, recovery experiments, method comparison and investigation of ruggedness. (14) have described how analytical methods are validated in a Japanese QC laboratory.
Table 2 gives examples of which parameters might be tested for a particular analysis task.
The scope of the method should also include the different types of equipment and the locations where the method will be run.
Representatives of the pharmaceutical and chemical industry have published papers on the validation of analytical methods.
Hokanson (9,10) applied the life cycle approach, developed for computerized systems, to the validation and revalidation of methods.Users must ascertain that the Reference Standards they are using are a "Current lot" or a "Previous lot" within the valid use date.Current and previous lot information is available in the Reference Standards listings and catalog.Ensure that USP Reference Standards are stored in their original stoppered containers away from heat and humidity and protected from light. View USP’s policy statement on Shipping and Storage Conditions of USP Reference Standards.Ensure that Reference Standard substances are accurately weighed—taking due account of relatively large errors potentially associated with weighing small masses—where it is directed that a standard solution or a standard preparation be prepared for a quantitative determination.This proposed procedure assumes that the instrument has been selected and the method has been developed.