by
Rande » Fri Apr 06, 2007 10:54 pm
I fully agree that you should have clearly defined and documented integration methods for your standards (especially for system suitability).
If your method is not reproducable enough to integrate your standards, how can you trust your results?
You should have "suggested" integration methods for each product. Often there will be differences; lot to lot variation or samples from accelerated stability studies, that require modified integration methods. My procedure is to clearly document the revised integration method, then use that method for all replicates of the sample. Sometimes there will be a noisy baseline for one replicate injection that requires "manual intervention" with the integration. A brief memo is included with the assay results to show the revised integration method.
Just a tip - I like to create a screen view on the computer with a "Blow Up" of the integrated chromatogram and the integration table. I then COPY the image on the computer screen by using the "print screen" key and PASTE it into a word document (along with appropriate discrriptions and assay information). This allows me to make a clearly understandable one page memo that I then sign and include with the assay data. I make no claim that this is the official (part 11 compliant) records. The complete assay run is stored by the HPLC software - this is just a brief memo to show the integrated peaks and "integration event table".
Make sure you have good scientific justification for everything and it does not look like you are trying to hide something.