Stability of IPs [GxP / QC / QA]

posted by ElMaestro  – Belgium?, 2020-06-10 16:17 (177 d 06:34 ago) – Posting: # 21525
Views: 851

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

Complete thread:

Activity
 Admin contact
21,240 posts in 4,431 threads, 1,482 registered users;
online 2 (0 registered, 2 guests [including 1 identified bots]).
Forum time: Friday 22:52 UTC (Europe/Vienna)

Normality is a myth; there never was, and never will be,
a normal distribution.    Roy C. Geary

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5