Hello Everyone,
Can you please help me by giving information about difference between Batch no. & Lot no. for finished product & raw material.
Any reference will be helpful.
Thanks in advance.
Regards
Sharmin
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Reference: WHO - Good Manufacturing Practices for pharmaceutical
products: main principles (GMP guidelines,) Annexure-4, TRS 908- 2003. Please refer Glossary section.
Batch (or lot)
A defined quantity of starting material, packaging material, or product processed in a single process or series of processes so that it is expected to be homogeneous. It may sometimes be necessary to
divide a batch into a number of sub-batches, which are later brought together to form a final homogeneous batch. In the case of terminal sterilization, the batch size is determined by the capacity of the autoclave. In continuous manufacture, the batch must correspond to a defined fraction of the production, characterized by its intended homogeneity. The batch size can be defined either as a fixed quantity or as the amount produced in a fixed time interval.
Batch number (or lot number)
A distinctive combination of numbers and/or letters which uniquely identifies a batch on the labels, its batch records and corresponding certificates of analysis, etc
As per WHO guidelines there is no difference between Batch or Lot of pharmaceutical products or API.
However, in general as per pharma industry practice, in the manufacturing of a Batch of tablets if granulation is to be carried out in small portions, then each portion is called ‘Lot or sub-lots’ . After granulation, all the lots or sub-lots of dried granules are then mixed to get one batch which is then lubricated with lubricant powders and compressed into tablets.
Similarly, coating of tablets in one batch can be carried out in a number of Lots or sub-lots. After coating, all the Lots or sub-lots of coated tablets are mixed to get one batch.
It is to be ensured that all lots or sub-lots in a batch must have the same characteristics and specifications. Only after ensuring that all Lots or sub-lots comply as per specifications then those can be mixed to get one batch.
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oh. Thank you very much Sir for your reference and broad elaboration. now it is clear to me. thank you again.
You are always welcome.
I have a follow-up question about this. You said, as per guideline, combine the lots during blending/lubrication, in this case if the bin-blender lack the capacity to combine the lots i.e if the bin-blender is small, can each lot be lubricated separately and combined into the same batch?
Furthermore, how to mix the lots after coating? Do you mean packing them in the same batch?
Please enlighten me.
I did not say that there is a guideline to combine the lots during blending/lubrication. This is an industry practice.
Secondly, we can give the same batch number to the sub-lots of coated tablets, only if every individual sub-lot meets the finished product specification. Alternatively, you can provide prefix- A, B, and C to the main batch number of the finished product in order to maintain the identity of individual sub-lot of coated tablets. For example, if you manufacture a batch of tablets (until core tablets-before coating) having Batch number 230805, and you divide tablets of this batch into three sub-lots for coating purpose, then you can give after coating the batch number for individual sub lot (coated finished product packed) as 230805-A, 230805-B, 230805-C. This will ensure the identity of individual sub-lots of coated tablets. It is to be ensured that all the sub-lots must meet the finished product specification when analyzed individually. You may combine individual lubricated granules after compression in to tablets. However, individual lots of compressed tablets must be analyzed separately and must meet the finished product specification, only then you can combine them. It is required to maintain the identity of individual lots of compressed tablets by giving separate batch (sub lot) numbers as I have explained above with an example.
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