Batch Numbering System

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5 days ago

Batch Numbering System

1.0 Objective
To lay down a procedure for batch numbering system for products.
2.0 Scope
This Standard Operating Procedure is applicable for batch numbering system of all dosage forms

which includes Tablet, Capsule, Liquid, Lozenges and Dry powder injection for Domestic

and Export to be followed at formulation plant of abc Pvt. Ltd.
3.0 Responsibility
3.1 Officer / Executive QA shall be responsible for assigning the batch number to particular
product as per requisition received from production department.
3.2 Head-Quality Assurance or his/ her designee shall be responsible for compliance of SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QA : Quality Assurance
No. : Number
Batch : Batch means a specific quantity of drug and other materials that is intended to have

uniform character and quality, within specified limits and is produced according to single

manufacturing order during the same cycle of manufacturing.
Batch Number : Batch number means any distinctive combination of letters, numbers or

symbols or any combination of them from which the complete history of the manufacturing,

packing, holding and distribution of a batch or lot of drug product or other material can be determined.
5.0 Procedure
5.1 Batch numbering system for domestic market
5.1.1 A unique batch number shall be given to all batches for domestic market by the QA Officer/ Executive.
5.1.2 Two batch number of same or different product shall not match with each other.
5.1.3 Product code list shall be prepared by QA Officer/ Executive as Annexure-1.
5.1.4 Product code shall be given based on dosage form in three digits.
5.1.4.1 Code for liquid Oral starts from 001.
5.1.4.2 Code for Lozenges starts from 101.
5.1.4.3 Code for Dry Powder Injection starts from 201.
5.1.4.4 Code for Capsule starts from 301.
5.1.4.5 Code for Tablet starts from 401.
5.1.4.6 Code for Lozenges (Export) starts from 1101.
5.1.5 Batch number shall correlate with the product by means of product code.
5.1.6 Batch number for domestic market shall be of 09 alphanumerical characters in

following way RXXYYYZZZ Where,
R stands for Abcplant plant.
XX stands for last two digit of year.
YYY stands for three digit product code.
ZZZ stands for serial number of batch starting from 101, 102,103 at the start of each years.
5.1.7 For example batch umber for Reziz tablet shall be given as R1015101 where
R stands for Abcplant
10 stand for last two digits for year-2010
415 stand for three digit product code.
101 stands for serial number of batch i.e first batch of each product shall have a serial no. starting from 001.
5.2 Batch numbering system for Physician sample of Domestic product.
5.2.1 Similar mother batch number of the product shall assign to physician sample of the same

batch of the product in a same sequence as domestic batch.
5.2.2 Physician sample shall be packed from the commercial batch or separate physician batch

shall be prepared as per requirement received from marketing/ planning.
5.2.3 If the physician sample is taken from commercial batch, then Production Officer/ Executive shall

fill the batch conversion note as per SOP No.: QA/050.
5.2.4 Batch number, Manufacturing date and Expiry date of physician sample shall be same as the

mother batch (Batch from which physician sample taken).
5.2.5 If separate batch for physician sample is required, then batch number shall be given

from same serial number of sale batches.
5.3 Batch numbering system for export batch:
5.3.1 QA Officer/ Executive shall give the batch number to each export batch after receiving

requisition from production departments.
5.3.2 Product code shall not be included in batch numbering system.
5.3.3 Batch number for Export market shall be of 07 alphanumerical characters in following way REXXYYY, where
R stands for Abcplant Plant
E stands for Export
XX stands for last two digit of Year.
YYY stands for serial number of batch, like 001,002,003.
5.3.4 In case of export batches, batch number of two or more different products may have same Batch No.

this can be differentiated by product name only.
5.3.5 Batch number for export market (Lozenges) shall be of 06 alphanumerical characters in following way RCXYYY, where
R stands for Abcplant Plant
C stands for Country Name
X stands for Flavor
ZZZ stands for serial number of batch, like 001,002,003
6.0 Forms and Records
6.1 Product Code List – Annexure- 1
7.0 Distribution
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copy – Quality Assurance, Quality Control, Production & Warehouse
8.0 History