Batch Numbering Procedure

Batch means a specific quantity of drug that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle in manufacture.

Batch number means distinctive combination of letters, number, or symbols, or any combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a batch is traceable.

The batch number shall be unique Five-digit all numerical number in sequential order.

The first batch number shall start from 00001 and this numbering system shall continue till batch number 99999.

The sequential batch numbering shall be applicable to all the products manufactured in BPL track II irrespective month or year of manufacture.

The sequence shall continue up to 99999, however new sequence shall start again from 00001 after reaching batch number 99999.

If different packing material is used for packing one batch for supplying product to different market/customer then an alphabet of capital letter (A, B, C etc.) will be subsequently added at the end of batch number in the packing batch record. For example, three different packing materials are used in a batch number 22222 for supplying different market/customer then the Batch Packing Record (BPR) number of the batch will be 22222A, 22222B, and 22222C.

Batch numbering system for a common blended granules shall be unique three-digits all numerical numbers in sequential order.

The first batch number shall start from 001 and this numbering system shall continue till batch number 999.

The sequential batch numbering shall be applicable to all the common blend (granules) manufactured in BPL Track-II irrespective month or year of manufacture.

The sequence shall continue up to 999, however new sequence shall start again from 001 after reaching batch number 999.

And the batch numbering system for more than one product from common blended granules shall be unique Six-digit alpha numerical numbers (three digits numerical & three digit alpha). First three digit shall be the batch number of the common blended granules from where the batch has been produced & the last three digit shall be the product code, e.g. for a batch of Atova 10 mg Tablets (product code A3T) from a common blend (Batch No. 001), the batch numbering system will be 001A3T whereas for a batch of Atova 40 mg Tablets (product code A4T) from the same blend (Batch No. 001), the batch numbering system will be 001A4T etc.

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