BATCH NUMBERING SYSTEM - SOP

1.0
PURPOSE :

To lay down a standard procedure to describe the steps to be followed for Batch numbering system for all the products manufactured at the facility

2.0 SCOPE:

This SOP is applicable to all the batches (Local sale & Export) manufactured at the facility

3.0 RESPONSIBILITY:

Quality Assurance department

4.0 ACCOUNTABILITY:

Quality Assurance Head

5.0 DEFINITION: Nil

6.0 PROCEDURE:

6.1 Batch Numbering System

6.1.1 Following batch numbering system should be followed for all batches (Local sale & Export) manufactured at the facility
Batch number should be given as follow :
‘XY’

6.1.2 Where,
‘X’ denotes the product master code .(Refer Item codification system, xxxxxx)



6.1.3
‘Y’ indicates four digit numerical serial number starting from 0001.

e.g. RBFE03001 will be the batch number of first batch of the Rabiprazole manufactured.

6.1.4 Batch number of product shall remain same even if a batch is to be split into two or more different packs at packing stage e.g. Local sale, Physician’s sample, Export and different marketing company.

6.1.5 If there is any special requirement of the importing company for assigning the batch number then it will be assigned accordingly.

6.1.6 Batch number should remain void in case of cancellation of planning and should not be allotted to any other batch.

7.0 REFERENCE:

7.1 Item codification system.: QAP:xxxx

8.0 ENCLOSURE: Nil

9.0 ABBREVIATION: Nil