Chromatography Forum

Hi to all upto now for residual solvent test in all samples i develop In House method and i will validate it, What ever the method i have for Residual solvents Test is Validated by us. Is it mentatory to do test USP 467 or any equalency i want to show for my methods to comply FDA Audit.

The USP test is meant to be a test to decide the answer when a dispute occurs between two parties. Either between two companies, or between a company and the USP.

If your method is validated with a sound and defensible validation there should be no requirement to demonstrate equivalency to the USP test. And it is possible the USP test might not be suitable for your analysis.

But it sure would be nice to have that data to show to anyone who might contest your method.

But required? No.

best wishes,

Rod

Thank you Mr.Rod. Kindly suggest me have any parameters i want to include in the below Validation parametes which i follow current in my lab.

For Head Space GC Validation

System Suitablilty, Syatem Precision, Specificity, Linearity (8 Level LOQ to 150% of Specified Concentration), LOD & LOQ (S/N Ratio method), Accuracy (LOQ Level, 50%, 75%, 100% & 125% of Specified Concentration), Intermediate Precision, Robustness (Carrier Flow, Oven Temperature, Injectro Tem, Detector Tem, Head spece Sample Tem and Vial Thermostate Time)

For GC Validation

System Suitablilty, Syatem Precision, Specificity, Linearity (8 Level LOQ to 150% of Specified Concentration), LOD & LOQ (S/N Ratio method), Accuracy (LOQ Level, 50%, 75%, 100% & 125% of Specified Concentration), Intermediate Precision, Robustness (Carrier Flow, Oven Temperature, Injectro Tem and Detector Tem)

And i have one more quary the method Validation have done by our Research and Development lab only Method Transfer to our QC lab is sufficient or the QC lab also want to repeat the same validation in their end. Our QC is located 250 km away from our Research and Development lab.

The answer I propose is that the more data you have to show the method works in another lab the same way it worked during validation the stronger your defense of your method. Isn't that the reason you are doing all this work anyway?

This separate lab hardware and chemist performance demonstration adds confidence to your method. I would repeat the entire validation experiment; but especially the method LOQ, precision, accuracy, linearity, range of measurement, and robustness.

Your company should be doing this to produce a product in which they have confidence in its specifications, so those doing work with this product can have confidence in its consistent quality, thus, they have confidence in their work using the product.

best wishes,

Rodney George