Where do the Acceptance Criteria in Method Validation Come From?

LinkedIn

MTS Helpdesk

Webinar Recording

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.

Submit a Question to the MTS Helpdesk

Do you have a question for our expert relating to the topic of analytical chemistry? Use our enquiry form to send it to us.

Submit a question to the MTS Helpdesk
Related content from our Resources Library
What is Analytical Method Validation?
MTS HELPDESK: In ICH Q2(R2), the guideline about validation of analytical procedures that is used in the pharmaceutical/biopharma industry, it …
When do I Need to Follow ICH Q2(R2) & Q14?
MTS HELPDESK: When do I have to start following the updated ICH guideline, Q2(R2) and the new guideline, Q14?
Why Perform a Validation Gap Assessment?
MTS Helpdesk: Why would it be necessary to perform a gap assessment of validation data that has been generated following …
More…
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.