Chromatography Forum

Hello, my name is German.
In my country a lot of manager of quality and research are working in this problematic situation.
We are writing an article for the official regulatory agency,
about how validate the analytical technics, to pass the problem derived of low acetonitrile disponibility in our country.
The idea is:
To assay and UC, only re-validate these points such as
- Accuracy
- Linearity of accuracy
- Specificity
- All items must pass the system suitability, similar to the original method.
But the problem is the impurities, we are thing only study:
- Linearity
- Lc & LD.
What are we suggest about that? Thanks and sorry for my english
Bye

Ph German Garcia
Quality and Research Manager
Paylos Laboratories SRL

No apologies necessary. Your English is much better than my Spanish!

My answer would be that you must revalidate *everything* that might be affected by the change in solvent. That would obviously exclude things like sample preparation and solution stability.

My answer would be that you must revalidate *everything* that might be affected by the change in solvent. That would obviously exclude things like sample preparation and solution stability.

To appease our pointy-haired QA, we also revalidated our sample preparations on the several test procedures we revalidated using ACN-free HPLC solvent. Our sample preparations did not use ACN, and our sample preparations did not change at all, but our boss felt it was easier than fighting this issue, to save our fight for another day.

Now that the situation is getting better, our less frequently used ACN-using assays will probably not be revalidated using ACN-free conditions as there wouldn't ever be economic payoff, even at high ACN prices. Our revalidation projects were to cover our major products just in case ACN was completely unavailable at any price for 2 years.

Thanks for read me article,
Next monday I have a meeting with the regulatory agency to solve this situation.
At monday night I will paste the document in this site.
Bye