Dear All,
Please help me on following issue.
How much residue can be present of previous batch during manufacturing?
for example: batch size is 245 kg. but due to presence of previous batch residue, batch size is increased. how much residue can be present that is acceptable.
please help me with reference.
note that: line clearance was done. but still some residue was present.
Looking forward to your response please.
Previous product residue content generally termed as MACO.
MACO:Maximum allowable carryover.
Acc.criteria:
For between intermediate products MACO will be be 100PPM., whereas for API products MACO will be 10PPM.
How to calculate maco?
Thank you very much.
our product batch size found increased after batch completion. initial batch size was 245 kg, but yield found 105%. we are assuming that batch size quantity increased due to presence of previous batch residue. batch size increased to 254 kg. moisture effect is low in this product. is it comply GMP.
please help.
what was the yield of previous batch? is it less than 95%??
it was 97%.
there is difference of 9 kg in batch size , how you did not see this quantity before starting next batch??
Before starting of the next batch in the same equipment, you should ensure the cleanliness of the equipment.
While you checking if you found any residue of previous batch, you have to clean the equipment and proceed to next batch charging.
**In this case, Cleanliness means no need to clean the equipment for every batch.
You can go ahead with general cleaning, i.e; rinsing with the suitable solvent.
**You can establish the cleaning frequency of the equipment for the manufacturing of the same product…
Actually there was product carryover happened batch to batch . it was assumed that there may present product residue in finger bag of hopper which could not be cleaned through minor change over. thus during campaign batch of same product it was observed that last batch size of the campaign found increased.
There must not be carry-over product residues of the previous batch(s) into the next batch such that the yield is increased. Appropriate cleaning has to be done within the campaign of the same product. This should be verified by QA during “Line clearance” certification.
what action to be taken for above case? how we can justify the yield above acceptable limit? is it unplanned deviation?
As there will not be any proper justification, this should be considered as a deviation.
In order to avoid such an event following actions are recommended,
-To establish cleaning procedures of all equipment used in the manufacturing between batches of the same product (in a campaign) such that there will not be visible product residues in the manufacturing equipment.
-The FBD finger bag also must be dry cleaned to remove adhering powder residues of the previous batch.
-There should be Line clearance certification by QA to ensure that there are no visible residues in the equipment.
-If inadequate cleaning of equipment is not the only reason for getting a higher yield then further investigation needs to be conducted to find out the root cause(s). such as excess material dispensed, higher moisture content in the granules than the limits, etc.
Dear All,
Thank you for your effective feedback.
It will be much helpful for me if you can help me with any reference about this issue " how much percentage of batch size can be increased’. How much is acceptable.
Thank you so much for your help with feedback. we will proceed accordingly.
You are always welcome.
which is product generic name?
105% yield is not problem the critria
can be approve the BMR include
only specific Product yield range
yes its acceptable specific generic
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