ow many days performed Hold time study analysis…?
It’s not mandatory for you to perform hold time study for these many number of days. If your in-process materials are on hold for 30 days and if you have your predetermined hold time study data for 30 days then you are on safe side.
If your materials are on hold for 45 days and you have previously established hold time data for only 30 days then you are at risk. At this time point you have to work smart and process the materials as early as before 30 days or you have to sample it as part of an incident or deviation and have to perform analysis for assay, uniformity and impurities. If the material belongs to any wet granulation process, performing microbial test is also suggested. Once you get the pass results you are good to perform further downstream processing.
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It’s depends on your procedure, how many days you could store the material.
Thanks sir…
It Depends on products stability nature and
How much time we holding at our side to final use or release.
1,3,6,9,12 long term and 1,3,6 accelerated study required for hold time study’s.
Most probably for intermediates, KSM, CRM and also depends on customers requirements we keep it.
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Please refer WHO Guidelines, TRS 992, Year 2015 of General guidance on hold-time studies.
Please refer Table A4.1 in the above WHO guideline for Examples of stages, study times and tests that may be considered, based on risk assessment and specific product needs.
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