Validating test methods

Once these understandings are well documented and expressed in understandable process specifications and controlled via appropriate equipment operating ranges and procedures, only then can we make risk based decisions on the most appropriate experimental designs and sampling plans for each validation project, based on everything learned during the iterative development stage.It becomes easier to see when you consider the model above, and contrast it to a TMV program that is limited in scope to a Gauge R&R spreadsheet, why those programs leave Quality Management in the proverbial and unenviable position of defending why we are placing round pegs through square holes.

In the absence of an agency voice, the industry adopted a tool developed decades ago by the automotive industry, and began using the terms “Test Method Validation” and “Gauge R&R” interchangeably.The real trick to proving their suitability for use, is proving that we understand the upper limits of the potential measurement error, because the upper limit of the method uncertainty has to be added to the upper limit of the production uncertainty in order to defend the ability of the measurement system to reflect our manufacturing process in a way that is true and a wonderful tool for organizations performing chemical and biological laboratory analyses, concerned with quantifying and/or qualifying the components of drug product, but its value in that area is directly related to its specificity to those concerns.Usually the test result is the dependent variable, the measured response based on the particular conditions of the test or the level of the independent variable.Some tests, however, may involve changing the independent variable to determine the level at which a certain response occurs: in this case, the test result is the independent variable.

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The way validity is conceptualized determines the scope and the nature of validity investigations and hence the methods to gather evidence.

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