Where do the Acceptance Criteria in Method Validation Come From? - Webinar Recording

This video is a recording of a webinar originally presented by Oona McPolin of Mourne Training Services Ltd on the 29th July 2020. An additional session was delivered on the 12th August 2020.

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(R1), 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.

Navigation:
0:00 Introduction
0:12 Webinar info
4:51 What are Acceptance Criteria?
6:39 General Recommendations
7:48 How do you decide what acceptance criteria to set in your protocol?
9:53 Acceptance Criteria are required for the Method Performance Characteristics (referred to as 'Validation Characteristics in ICH Q2)
10:07 Quantitative Methods
12:21 What is 'Error'?
13:11 Types of inherent error
14:29 Random Errors
15:02 Statistical treatment of random error
15:45 Example of a Random Error
20:23 Systematic Errors
20:42 Example of a Systematic Error
24:24 Which is the correct integration approach in this situation?
31:19 Uncertainty of Measurement
33:02 Measurement Uncertainty References
33:56 Magnitude of Analytical Error Example
36:25 Typical values for Accuracy (Trueness)
38:12 Typical Criteria in Pharma Expressed as % Recovery
39:47 Typical Values for Precision
41:46 Summary of key points

[DeniseLawlor-qe]

do you have an references for what you have discussed that I could look up?

[tanvirahmedsohag]

Thanks for the HPLC calculator I use it a lot

[phelanapostol]

Hello, regarding the criteria for the accuracy and precision, what if I am analyzing an analyte with a true concentration of 5000ppm and I quantify it using external calibration with an analytical range of 1ppm to 10ppm, wherein the sample mass was 0.5grams and the total dilution factor of 500 to fit the sample in the calibration curve, what will be my acceptance criteria for accuracy? is it on the level of the analytical range (1-10ppm) or on the level of 5000ppm?

[thehealer]

this webinar did not provide any information regarding acceptance limit or criteria for validation parameter?? from usp or fda or ich. guideline for acceptance criteria for each parameter of method validation especially accuracy

[inticorrientes]

what about Horwitz Ratio as a precision acceptance criteria? what should I look in order to know if it is a good criteria for a particular method?

[satnamom]

Hello mam, I like your webinar very much. I have one query... During precision studies, we carry out 6 replicate analysis. The %rsd of these should be calculated of rounded values or unrounded values?