Loky do
☆    

Egypt,
2020-06-10 13:31
(334 d 19:25 ago)

Posting: # 21522
Views: 1,364
 

 Stability of IPs [GxP / QC / QA]

Dears

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?

Thanks


Edit: Category changed; I think that this one is more appropriate. [Helmut]
ElMaestro
★★★

Denmark,
2020-06-10 18:17
(334 d 14:39 ago)

@ Loky do
Posting: # 21525
Views: 965
 

 Stability of IPs

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
Loky do
☆    

Egypt,
2020-06-16 13:24
(328 d 19:32 ago)

@ ElMaestro
Posting: # 21545
Views: 914
 

 Stability of IPs

Thanks EL Maestero for your reply

» 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.

Yes, actually I'm working at a CRO in Egypt and the drug samples were under our authority until performing bioequivalence studies for them and this excursion happened during a strong wind storm, therefore we couldn't reach the CRO at that time, reverting to the manufacturers they already performed accepted stress stability studies at 40°C & 75%RH for the products, is that enough for an explanation of this excursion for regulatory authorities or reanalysis of the existing samples must be done and compared to results obtained before the storm?

Thanks
Activity
 Admin contact
21,446 posts in 4,483 threads, 1,511 registered users;
online 13 (0 registered, 13 guests [including 13 identified bots]).
Forum time: Tuesday 08:57 CEST (Europe/Vienna)

The fact that some geniuses were laughed at
does not imply that all who are laughed at are geniuses.    Carl Sagan

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