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SOP for Batch Numbering System in Pharma | Product batch

number example |

1.0 OBJECTIVE
To describe a procedure for allocation of batch number for product.

2.0 SCOPE
This procedure is applicable to all products manufactured for loan license party and own
products.

3.0 RESPONSIBILITY
QA Chemist and above

4.0 ACCOUNTABILITY
QA Head

5.0 PROCEDURE
Note: Batch Number Allocation may differ from company to company. This is one of the
examples.
5.1 Batch number is unique and continuous series. It is not product specific.
5.2 Assign batch number to the product in batch allocation register as well as manufacturing
and expiry date after receiving work order or mail from commercial department.
5.3 Allocation of batch number to the product will be carried in two types;
1) In-house batch numbering system
2) Batch numbering as per party`s requirement
l In- house batch numbering system:
o Batch numbering will be manufacturer specific in this batch numbering system.

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 o Batch number will consist of 6 alphanumeric characters, 1 alphabet and 5
numerical.
o In this numbering system, first character will be an alphabet in capital which will
be as per drug Manufacture License.
o Assign further alphabet for additional party who would take loan license with
Manufacturers in future and update list for specific code.
o After Alphabet next numerical indicates year (last digit of year) of product
manufacturing.
o Remaining four Numerical will be serial Number of batches taken in period of one
calendar year.
o Every year from 1st January onward, serial no of batch start from 001 and will be
continued till the end of 31st December and may go up to 999.
o For example,
A22001:
 In this batch number A indicates specific code for License Number.
 22: Indicate year of product manufacturing.
 001: Indicate serial No. of batch manufactured in year 2022.
o Batch Number shall be allocated and recorded as per Annexure No. : 01.
o List for specific alphabet as per drug manufacture license number.

Sr. No. Specific Loan/own Party Name

Alphabet license No.
01 A abc Own
02 B xyz Party

l Batch numbering as per party requirement:

o Allocate batch number serially as per party requirement.
o It has to be taken into consideration that batch assigned by party shall not create
any confusion or conflict with existing In- house batch numbering system while
allocating batch numbers.
o Make sure that adequate product traceability through party required batch
number is maintained.

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 o Batch number shall not be repeated with In-house batch numbering system.

6.0 ABBREVIATIONS
Abbreviation Expanded form
SOP Standard Operating Procedure
QA Quality Assurance
Mfg. Manufacturing
Exp. Expiry

7.0 ANNEXURES:
Annex. No. Title
01 Batch number allocation register

8.0 SOP REFERENCES

 In-house SOP…

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ANNEXURES:
Annex. No. 01 Batch number allocation register