Manual integration [Bioanalytics]

posted by ElMaestro  – Denmark, 2021-12-01 14:40 (297 d 10:15 ago) – Posting: # 22681
Views: 883

Hi Helmut,

As I see it, FDA have been completely adverse to manual integrations for a decade at least. Manual integrations not accepted. At all. In any form.
And therefore many CROs have adopted similar policies - they have to run the validation and sample analysis without ever touching the MI function. Some CROs allow for MI if the intended submission is EU/ROW/WHO etc but do not open that option if the submission targets US.
The approach is, as I see it, completely safe: If you can run the val. and the sample analysis without MI then you have a great setup and you are not disturbing anyone. But still runs need to be approved and still someone should somehow sign off for the peak identification and correct integration. Which also means that it is a bit demanding from the equipment perspective. You need something which has a noise-less baseline, which means equipment sensitivity, colums integrity and method development is paramount.

I am aware of the wording in M10 which other suggests there may be a way for MI. I have not, hoever, heard of FDA taking any another stance in practice.

Finally, everything evolves, including integration algorithms. Perhaps what was pretty bad in 2009 is pretty good in 2021? There is no good way to evaluate it. I don't have a way to import WIFF files from 2009 into Analyst 1.6.5 or whatever today's version is. But if someone has a way to it, let us see some results :-)

So, I am fine with CROs trying to avoid MI as long as what it is meant is the aim to have a method that is so sensitive that even at low concs the integration is good. That also means the deficiency letter is a walk in the park.

Pass or fail!

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