Stability of IPs [GxP / QC / QA]

posted by Loky do – Egypt, 2020-06-16 15:24 (1494 d 07:23 ago) – Posting: # 21545
Views: 2,138

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?


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