Guidlines or ref for return of exceptiets from production area to Raw material store?
What is reason of receiving extra material?
To adjust potency of API.
we have standrd formulations but assay of API varry lot to lot so some time we have to return some qty of exceptien back to store.
Include the calculation part in BMR.calculate the required raw material on basis of assay, lod or water content.without calculation how u can know required quantity of raw material?
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Calculation is the part of BMr.Manufacturing order is originated according to known assay of raw naterial.But BMR is accordibg to standrd Formation which is the adjusted acc to Mfg order.
Every step and calculations are pat of BMr.
Evey time we can not change BMR standrd RM qty acc to Assay bcz assay vary lot to to n chang in BMR req chang control.
Can u make a table for std.qty. vs actual qty.
Is standard qty. based on 100% assay.
yes standrd qty based on 100 prcent
You can make a table for dispensing sheet ,in which std qty. will be already printed and actual required qty. based on calculation will be hand written.
for exmple glimperide stndrd qty 0.500 kg after adjustment 0.550 .
and say avicel PH 102 is 4 kg then it will be reducex 0.05 kg of Avicel to adjust
yes we have same
now qes is that 0.05 kg is return to raw material store.it is corect procedure to return material from production area.any guidlines or gmp allow this?
It will be discarded.
In case of liquid injection we dispense standard qty.of HCl and NaOH for pH adjustment.in this case we discard remaining qty .of NaOH and HCl after pH adjustment.
Exactly got the point.
In past we use to return but now we have changed the procedure.we make WDN(waste disposal note) and send it for destructon.
same here in case of oral drops mfg we also discard Hcl by WDN
Yes it is good practice.