What is the logic behind the loading of samples in stability chamber should be completed within one month from the approval of finish product testing? And what is the referance guideline for that?
According to WHO TRS 1010, 2018 Stability testing of active pharmaceutical ingredients and
finished pharmaceutical products, it is stated that
The initial date of storage should be considered t0 and stability time
points should be defined as a date with respect to t0. For example, if t0 is
1 January 2020 then the one-month time point corresponds to either 1 February
or 31 January 2020. For each time point, samples should be withdrawn and
tested as per the protocol. Testing should be completed as soon as possible.
Deviations from the protocol should be recorded and justified.
Loading of samples in the stability chamber should be completed as soon as possible from the approval of finish product testing. This is because, if you consider the accelerated stability study, the frequency of analysis of loaded samples is 1, 2, 3, 4, 5 & 6 months. Therefore, it is obvious that the samples must be loaded into stability conditions before the first frequency (of 1 month) its analysis. If the samples are loaded into stability cabinets late then the calculation of frequencies (1, 2 3, 4, 5, 6 months) of analysing the stability samples will be erroneous. There is no specific regulatory requirement which defines within how many days the samples must be kept for stability studies in to stability cabinets. However, earlier is always desirable. There should be internal SOP to define zero interval (t 0). Generally it i san industry practice to load the samples for stability within a week from packing & QA release.
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