Difference between Batch no. & Lot no

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

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.

2 Likes

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.