Establishing acceptance criteria during method validation:
A method validation is necessary when a new method has been established and is supposed to use routinely for the intended purpose. There are requlatory requirements and guidelines to be applied to take criticali points into account during method validation. i The ICH Q2(R1) is one of them. This guideline "Validation of analytical procedures: text and methodology", published by the ICH, offers help with respect to number of parameters to be considered during validation, but more often not on the acceptance criteria. This article is aimed to provide quidance on the acceptance criteria which are accepted by most of the regulators.
A method validation is necessary when a new method has been established and is supposed to use routinely for the intended purpose. There are requlatory requirements and guidelines to be applied to take criticali points into account during method validation. i The ICH Q2(R1) is one of them. This guideline "Validation of analytical procedures: text and methodology", published by the ICH, offers help with respect to number of parameters to be considered during validation, but more often not on the acceptance criteria. This article is aimed to provide quidance on the acceptance criteria which are accepted by most of the regulators.
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