When pulling routine batch stability samples to be tested, within what time of being pulled do the samples have to be tested in order for the results to be valid?
In general, stability samples withdrawal and testing excursions for accelerated and long-term storage conditions are as follows.
Excursions for Samples withdrawal:
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
Excursions for testing and reporting of results:
The analysis should be completed within 3-5 days from the date of withdrawal.
After analysis review & approval should be completed within 3 days and can be extended in case of any microbial or external laboratory testing is associated.
If any deviation occurred from the above-mentioned timelines, deviation should be initiated and justification to be provided.
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