Where do the Acceptance Criteria in Method Validation Come From?

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One of the most difficult tasks when writing an analytical method validation protocol is to set suitable acceptance criteria, particularly for the characteristics of accuracy and precision. It sometimes seems that the values are just plucked out of the air! Available guidance documents, such as ICH Q2(R2), don’t mention any numbers.

In this webinar we looked at the relationship between inherent analytical error and validation acceptance criteria to give an understanding of where typical values come from.

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Services related to this content that we offer

The topic of validation acceptance criteria is included in our courses, ‘Validation, Verification and Transfer of Methods for Pharmaceutical Analysis‘ and ‘Validation, Verification and Transfer of Methods for Biopharmaceutical Analysis‘.

Visit our courses page for a full list of available courses and the schedule of currently available course dates.