Stability of IPs [GxP / QC / QA]

posted by ElMaestro  – Denmark, 2020-06-10 18:17 (413 d 03:02 ago) – Posting: # 21525
Views: 1,023

Hello Loky do,

» To what extent an increase in humidity affects Investigational products stability? if the humidity of the drug store reached > 70% what will be the accepted measures taken to prove that no impact has occurred to samples?

In Europe, this would often be a question for the manufacturer or release officer: Details of the temperature excursions can be shared and then the QP will make a decision. There is some subjective judgment involved unless the parties sit on actual stability evidence covering (=qualifying or disqualifying) the excursions. Depending on amounts available, there is also the opportunity to subject the IMP to new testing, i.e. production of a new CoA and subsequent release. In that case the testing is done with all the bells and whistles.

If you are working at a CRO and the temperature excursion happened there, then you are most likely not in a position to judge it on your own.

The above applies only to the regulated areas I know of. It is my impression that you are in Egypt and I do not know how things work if the phenomenon happened there.

Pass or fail!
ElMaestro

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