Chromatography Forum

Hello！My colleagues！There are some problems about Validation of analytical procedure to consult you！How do we estimate the data of Validation . In other words,I wonder if there is acceptance criteria about validation of analytical procedure，forexample,the data of HPLC method system suitability test,accuracy,precision etc .

sure there are

it all depends on the intended use of the method = ask your client what he wants

To expand a bit on grzesiek's response: Validation can be defined as demonstrating that a method does what it purports to do. What you have to go through to demonstrate that depends on who wants to know. It can be as simple as running one standard, or it can be very complex, involving replicates and inter-laboratory studies.

Hi

In other words,I wonder if there is acceptance criteria about validation of analytical procedure，forexample,the data of HPLC method system suitability test,accuracy,precision etc .

From a pharma buisness regulatory viewpoint there is not much in terms of acceptance criterias in the ICH guidelines. Some individual agencies may have a few expectations but to my knowlegde only APVMA (Australia) has set accetance criterias in their guideline for accuracy and precision depending on nominal % of target analyte, see page 5 in the link below.

http://www.apvma.gov.au/guidelines/down ... ethods.pdf

As Tom mentioned, the complexity depends on the purpose and field of work, guidance documents are good but may not "fit all" or reflect the current general "standard" of our instruments. For instance, as for precision in the pharma buissness a RSD of max 2,0% is the general rule, but I would say there is something wrong with "mine" instruments if I obtained a RSD of 1,0 to <2,0% in a general assay or impurity method, as such we tend to set the system suitability critieria to not more than 1,0%.

When I was validating methods for our clients, following ICH and FDA guidelines, the only one which had defined acceptance criteria was the FDA's bioanalytical method validation guidance.

For non bioanalytical methods we had default criteria depending on the calibration methods/ranges employed or we worked to criteria suggested by the contracting company

there would be more help from us if you could tell where you are, what you are doing, for what or whom, and so on