Chromatograms [BE/BA News]

posted by Ohlbe – France, 2022-06-14 13:37 (729 d 22:15 ago) – Posting: # 23056
Views: 2,187

Dear Qualityassurance,

❝ The ICH guidelines asks for 100% of chromatograms to be submitted. As per EMA and USFDA requirements Chromatograms from 20% of subjects are required.


❝ Should we start submitting 100% chromatograms now.


It will take a few more months before the guideline comes into force, but it will be applicable to any application submitted after a certain date, even if the trial was done earlier. I would suggest to start getting prepared and to start providing the sponsors with 100% chromatograms.

Regards
Ohlbe

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