A product during wet granulation is at stage of drying and after 5 min of drying FBD break down occur and it last for 15 hrs.what will be the fate of product?
Here now the situationā¦if actual drying time is suppose 45 min, so here the condition is still wet for 40 mins,ā¦what would have happenedā¦
So, either we can raise incident, investigation, capa, based on CAPA immediate action discard this quantity or lotā¦
Reissue the material, reissue relevant batch processing document and batch can be proceeded as usual
or
Management to decide what can be doneā¦
Thanks
i think to discard is very difficult drcision.if we have hold time studies for wet mass then no issue to proceed if time falls bw our hold time study data.Other wise after checking microbial activity in that lot and after drying assay of that lot can be proceeded.
Actually as per the regular industry practice hold time is covered as a dried granule stage or final blend, rarely you may find as wet massā¦
Or we can proceed with approved reprocessing format including more number of racking while drying as to avoid lump formationā¦
Also if itās lot B, shall be processed as a different batch.splitingā¦ongoing stability to be monitoredā¦batch to be released after complete testing
Thanksā¦
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Hold time is also conducted for binder sol,and wet mass to avoid from such problems.
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