Allocation of Product Batch Number SOP

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:

• Q.A. Head

5.0 PROCEDURE :

Note: Batch Number Allocation may differ from company to company. This is one of the example.

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,

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

Sr. No.	Specific Alphabet	Loan /own license No.	Party Name
01	A	abc	Own
02	B	xyz	Party

• Batch numbering as per party requirement:
  • Allocate batch number serially as per party requirement.
  • 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.
  • Make sure that adequate product traceability through party required batch number is maintained.
  • 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

END OF THE SOP

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ANNEXURES :

Annex. No. 01 Batch number allocation register

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