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Clause 5.4.5 VALIDATION OF METHODS

This document is intended to provide a basis for a common understanding of theactivities related to validation of test methods .

Validation is defined as confirmation by examination and provision of objectiveevidence that the particular requirements for a specific intended use are fulfilled.

In the validation process, the objective is to estimate the representativeness,repeatability and reproducibility of the test method and secure adequateevidence that the method is its intended purpose.

The laboratory have to use appropriate methods and procedures for all tests/orcalibrations within its scope. These includes sampling, handling, transport,storage of items to be tested and calibrated, and where appropriate , anestimation of the measurement uncertainty as well as statistical techniques foranalysis of test and/or calibration data.

Standardized test methods published by National and International standardsbodies ( IS/ISO/IEC) or independent technical bodies ( ASTM,AOAC,IAEA etc.) orregulatory bodies ( Indian Phamaeopoea, EPA etc.) should be consideredvalidated for their intended application ( range and accuracy of measurement)

and thus fit for the intended purpose, even if the repeatability and reproducibilityare not known in detail. The testing laboratory must ensure that they apply themethod correctly.

For modified test methods or in-house developed test methods the testinglaboratory should determine the level of repeatability and reproducibility,keeping in view , the factors which affect the test results are sampling ,homogeneity , test method , equipment , personnel and test environment .

The effect of instrumental and technical factors can be minimized and controlledby making provisions like defining the equipment capability (range & accuracy) asprecisely as necessary , providing a clear description of the test procedureincluding instrument operation and establishing procedures for operationalcontrol and calibration of equipment with traceability of measurement .

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Clause 5.4.5 VALIDATION OF METHODS

Human factors are controlled through education/basic knowledge, practicalexperience and on job training.

The Qualification required for the personnel employed for a given test may, if necessary, be specified in the test method or in internal procedures.Environmental factors where they affect the test results are controlled andparameters are atmospheric conditions like temperature, pressure and humidity,contamination and other factors like EMC. The effect of any of the above factorson the test result shall be described in the test methods.

C0-operation between a certain numbers of laboratories working in the same

area for inter-laboratory comparisons provides the desired confidence particularlyin case of modified test method and is recommended.

The validation of test methods shall satisfy two inter-related steps are suitabilityof the test to satisfy the customer needs, and the demonstration of technicalcapability of the test method within the specified range.