Hi
Is there any guidelines that outline when testing for each time point needs completed. For example for a 1 months time point how long do you have to complete testing? Also can you test a 1 month and 2 month time point at the same time?
In general, stability samples testing excursions for accelerated and long-term storage conditions are as follows.
For accelerated conditions: +2 days up to 6 months
For Long term conditions: +4 days up to 6 months
For Long term conditions: +7 days more than 6 months
If any test interval deviated from the above excursion periods, then deviation shall be initiated and justification has to be provided.
Is this detailed in any guidelines. How can testing be completed within 2 days?
It is a good question.
As per WHO annexure 10 (Stability) general statement is given not specified time line
“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 For each time point, samples should be withdrawn and tested as per the protocol.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.”