Hi,
How will assign Manufacturing date for reprocessed batch?
Is this mother batch manufacturing date or re-process performed date?
Is there any guideline describes about particularly assigning manufacturing date for reprocessed batch?
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Manufacturing date of the re-processed batch is the date on which the batch is re-processed.
However, the expiry date of the re-processed batch should be the same as the expiry date of the original batch. Therefore,generally shelf-life of the re-processed batch is lesser than the original batch.
There is no specific guideline for this aspect. The industry practice is as above.
The WHO guideline Annex 3, WHO Technical Report Series, No. 961, 2011
WHO good manufacturing practices for pharmaceutical products: main principles.
The relevant portion about reworking and reprocessing is given below,
Rejected, recovered, reprocessed and reworked materials:-
The reworking or recovery of rejected products should be exceptional. It is permitted only if the quality of the fi nal product is not affected, if the specifi cations are met, and if it is done in accordance with
a defi ned and authorized procedure after evaluation of the risks involved. A record should be kept of the reworking or recovery. A reworked batch should be given a new batch number.
The introduction of all or part of earlier batches, conforming to the required quality, into a batch of the same product at a defi ned stage of manufacture should be authorized beforehand. This recovery should be carried out in accordance with a defi ned procedure after evaluation of the risks involved, including any possible effect on shelf-life. The recovery should be recorded.
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Can we reprocess near to expiry API to assign new manufacturing and expiry date?
If so, what will the expiry or retest date?