STANDARD OPERATING PROCEDURE
DEPARTMENT: QUALITY ASSURANCE PAGE 1 OF 2
HMA MEDICAL LIMITED Ilorin- Kwara State
TITLE: STANDARD OPERATING PRECEDURE FOR BATCH NUMBERING(2)
SOP NO.: SUPERSEDES: ISSUE DATE: EFFECTIVE DATE: MANDATORY REVIEW:
HMA/QA /036/R0 NIL 25/08/2022 12/09/2022 11/09/2025
1.0 PURPOSE: The purpose of this SOP is to describe the procedure for batch numbering
system for all products manufactured in HMA Medical Limited, Ilorin.
2.0 SCOPE: This SOP is applicable to process of batch numbering system for all
products manufactured at HMA Medical Limited, Ilorin
3.0 RESPONSIBILITY: Production Supervisor, Q.A Officer, Production Pharmacist, Quality Assurance
Manager, Supt. Pharmacist/General Manager
4.0 ABBREVIATIONS:
SOP Standard Operating Procedure QAD Quality Assurance Department
QA Quality Assurance BMR Batch Manufacturing Record
5.0 DEFINITION:
Not Applicable
6.0 PROCEDURE:
1. All batches of product to be manufactured in HMA medical Limited, Ilorin, must carry a batch
number
2. Batch manufacturing records shall be issue by the QA. Department upon request by the product
department
3. Record of BMR issue shall be kept in the BMR issue register
4. Each batch manufacturing record shall have its issue number and shall be duly authorized by the
Superintendent Pharmacist for production use.
NAME DESIGNATION SIGNATURE DATE
COMPILED BY Q.A. Executive
REVIEWED BY Quality Control Manager
APPROVED BY Quality Assurance Manager
AUTHORISED BY Superintendent Pharmacist
STANDARD OPERATING PROCEDURE
DEPARTMENT: QUALITY ASSURANCE PAGE 2 OF 2
HMA MEDICAL LIMITED Ilorin- Kwara State
TITLE: STANDARD OPERATING PRECEDURE FOR BATCH NUMBERING(2)
SOP NO.: SUPERSEDES: ISSUE DATE: EFFECTIVE DATE: MANDATORY REVIEW:
HMA/QA /036/R0 NIL 25/08/2022 12/09/2022 11/09/2025
5. All batches of products shall Follow the same batch numbering system, which shall indicate each
product code, year and month of production, as well as the serial number for the batch
6. XX – Representing the product code
7. 0001– Serial production number
8. E.g. –XX0001.
9. The batch numbering system shall be coded on all pouches and mono-cartons.
10. Each product shall carry its manufacturing month and year, the expiry month and year of expiry
11. The batch number of each batch of product shall be writing/ coded on the outer secondary carton of
the product
7.0 PRECAUTION/EHS:
Not Applicable
1. ANNEXURES:
Not Applicable
1. FREQUENCY:
As and when required
1. REFERENCE DOCUMENT:
Not Applicable
11.0 DISTRIBUTION LIST
1. Quality Assurance Manager
NAME DESIGNATION SIGNATURE DATE
COMPILED BY Q.A. Executive
REVIEWED BY Quality Control Manager
APPROVED BY Quality Assurance Manager
AUTHORISED BY Superintendent Pharmacist
STANDARD OPERATING PROCEDURE
DEPARTMENT: QUALITY ASSURANCE PAGE 3 OF 2
HMA MEDICAL LIMITED Ilorin- Kwara State
TITLE: STANDARD OPERATING PRECEDURE FOR BATCH NUMBERING(2)
SOP NO.: SUPERSEDES: ISSUE DATE: EFFECTIVE DATE: MANDATORY REVIEW:
HMA/QA /036/R0 NIL 25/08/2022 12/09/2022 11/09/2025
2. Superintendent Pharmacist
3. General Manager
12.0 REVISION HISTORY:
Not Applicable
NAME DESIGNATION SIGNATURE DATE
COMPILED BY Q.A. Executive
REVIEWED BY Quality Control Manager
APPROVED BY Quality Assurance Manager
AUTHORISED BY Superintendent Pharmacist
