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Clause 7.2.2.2, Changes to a validated Method.

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Tim Created:   Mar 03, 2021 Last commented:   Mar 04, 2021

Clause 7.2.2.2, Changes to a validated Method.

If a validated and published method (e.g. FDA, EPA, etc.) says that we can adjust parameters as necessary, e.g. column conditions, and we do choose to alter those parameters, is that considered a change to a validated method despite the method stating that we can indeed alter those parameters?

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Tracey Evans Mar 04, 2021

If the laboratory changes the conditions, within the “allowed” tolerances / restrictions; you are still using a standardized method. With or without such allowed modifications, it is required of the laboratory to provide objective evidence that the laboratory can achieve the performance reported for the standardized test method.  This means, verify achieving suitable performance of the validation parameters, such as accuracy. i.e. close to what is reported by the Standard method. The parameters to be included will depend on the type of method. Typically for quantitative assays of major components - Accuracy, Precision, Linearity and Specificity must be confirmed to be suitable. If however impurity and degradation determinations are being tested for minor components; the Limit of Quantitation would be required in addition to the previous parameters (for the impurity).

Look to regulatory requirements and guidelines, depending on your sector, for example FDA (see https://www.fda.gov/regulatory-information/search-fda-guidance-documents) and the International Conference on Harmonization (ICH) (see https://www.ich.org/page/search-index-ich-guidelines).

Also have a look at a related question (Verification and validation) at https://community.advisera.com/topic/verification-and-validation/
If you are interested, view the ISO 17025 toolkit procedure for validation and verification of methods, named Test and Calibration Method Procedure, along with two supporting documents Test Method Development, Verification and Validation Register and Test Method Development, Verification and Validation Record. The procedure is also available separately at https://advisera.com/17025academy/documentation/test-and-calibration-method-procedure/

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