SUN MOON PHARMACEUTICALS PVT. LTD.

Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra-401 506.
STANDARD OPERATING PROCEDURE
TITLE: BATCH NUMBERING SYSTEM
Department : Quality Assurance SOP No. : SOP/QA/007
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 1 of 5
Prepared By Reviewed By Approved By
Sign. with
Date.

1.0 OBJECTIVE:

To lay down the procedure for defining the unique Batch numbering system for to control various
types of products being manufactured and distributed by Sun Moon Pharmaceuticals Pvt. Ltd.

2.0 SCOPE:

This procedure is applicable for the Batch numbering system of all related products of the plant
batches, its intermediate stages and blend batches of finished products, intermediates and
reprocessed or reworked batches that are manufactured in this manufacturing unit of Sun Moon
Pharmaceuticals Pvt. Ltd.

3.0 RESPONSIBILITY:

Executive / Designee : Assigning of batch number

Dept. Head / Designee : Review, training and implementation

Sr. Manager – QA / Designee: Approval and compliance

4.0 PRECAUTIONS:

NA

5.0 PROCEDURE:
5.1 Batch Numbering System:

5.1.1 All batch numbers are sequentially numbered till it reaches to 999.

5.1.2 The Product code or API code shall consist of two digit alphabets in capital letters, as
per product wise examples which is given in Attachment-1.
5.1.3 The product code will be assign by Quality assurance department and Operation head.

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra-401 506.
STANDARD OPERATING PROCEDURE
TITLE: BATCH NUMBERING SYSTEM
Department : Quality Assurance SOP No. : SOP/QA/007
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 2 of 5
Prepared By Reviewed By Approved By
Sign. with
Date.

5.2 Batch Numbering System for Intermediate Stages:

The plant batch number system shall start as per following system:

SMP / YYI / AAA / XXX / CC-CC

SMP : Alphabets indicates for Sun Moon Pharmaceuticals Pvt. Ltd.

/ : Slash.
YYI : 2 Alphabets indicates for product code in caps & “I” Stands for Intermediate.
/ : Slash.
AAA : 3 Numerical indicates for Batch serial number, starting from 001.
/ : Slash.
XXX : Stands for month of the manufacturing
/ : Slash.
CC-CC : Stands for Financial Year of manufacturing

Ex: Batch number: SMP/PXI/001/FEB/19-20

SMP : Alphabets indicates for Sun Moon Pharmaceuticals Pvt. Ltd.

/ : Slash.
PXI : ‘PX’ Alphabets indicates for product code in caps & “I” Stands for Intermediate.
/ : Slash.
001 : 3 Numerical indicates for Batch serial number, starting from 001.
/ : Slash.
FEB : Stands for month of the manufacturing
/ : Slash.
19-20 : Stands for Financial Year of manufacturing

5.3 Batch Numbering System for Finished Product:

The plant batch number system shall start as per following system:

SMP / YYI / AAA / XXX / CC-CC

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra-401 506.
STANDARD OPERATING PROCEDURE
TITLE: BATCH NUMBERING SYSTEM
Department : Quality Assurance SOP No. : SOP/QA/007
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 3 of 5
Prepared By Reviewed By Approved By
Sign. with
Date.

SMP : Alphabets indicates for Sun Moon Pharmaceuticals Pvt. Ltd.

/ : Slash.
YYF : 2 Alphabets indicates for product code in caps & “F” Stands for Finish product.
/ : Slash.
AAA : 3 Numerical indicates for Batch serial number, starting from 001.
/ : Slash.
XXX : Stands for month of the manufacturing
/ : Slash.
CC-CC : Stands for Financial Year of manufacturing

Ex: Batch number: SMP/PXF/001/FEB/19-20

SMP : Alphabets indicates for Sun Moon Pharmaceuticals Pvt. Ltd.

/ : Slash.
PXF : ‘PX’ Alphabets indicates for product code in caps & “F” Stands for Finish product.
/ : Slash.
001 : 3 Numerical indicates for Batch serial number, starting from 001.
/ : Slash.
FEB : Stands for month of the manufacturing
/ : Slash.
19-20 : Stands for Financial Year of manufacturing

5.4 Batch Numbering System for Finished Product Blend Batches:

The plant batch number system shall start as per following system:

SMP / YYI / AAAB / XXX / CC-CC

SMP : Alphabets indicates for Sun Moon Pharmaceuticals Pvt. Ltd.

/ : Slash.
YYI : 2 Alphabets indicates for product code in caps & “F” Stands for Finish product.
/ : Slash.
AAA : 3 Numerical indicates for Batch serial number, starting from 001 & B Indicate
Blend batch.
/ : Slash.
SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra-401 506.
STANDARD OPERATING PROCEDURE
TITLE: BATCH NUMBERING SYSTEM
Department : Quality Assurance SOP No. : SOP/QA/007
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 4 of 5
Prepared By Reviewed By Approved By
Sign. with
Date.

XXX : Stands for month of the manufacturing

/ : Slash.
CC-CC : Stands for Financial Year of manufacturing

Ex: Batch number: SMP/PXF/001B/FEB/19-20

SMP : Alphabets indicates for Sun Moon Pharmaceuticals Pvt. Ltd.

/ : Slash.
PXF : ‘PX’ Alphabets indicates for product code in caps & “F” Stands for Finish product.
/ : Slash.
001B : 3 Numerical indicates for Batch serial number, starting from 001 & B Indicate
Blend batch.
/ : Slash.
FEB : Stands for month of the manufacturing
/ : Slash.
19-20 : Stands for Financial Year of manufacturing

6.0 LIST OF ANNEXURES / ATTACHMENTS:

ATTACHMENT – 1 Product /API Codes SOP/QA/001-F01.00

7.0 ABBREVIATIONS:
SOP Standard operating procedure
No. Number
NA Not Applicable
REV. Revision
API Active pharmaceutical ingredient
INT Intermediate
Dept. Department

8.0 REFERENCE:

ICHQ7

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization
 SUN MOON PHARMACEUTICALS PVT. LTD.
Plot No. N-65, M.I.D.C. Tarapur Boisar, Dist. Palghar, Maharashtra-401 506.
STANDARD OPERATING PROCEDURE
TITLE: BATCH NUMBERING SYSTEM
Department : Quality Assurance SOP No. : SOP/QA/007
Effective Date : Rev. No. : 00
Review Date : Supersedes : NA
Copy No. : Page No. : 5 of 5
Prepared By Reviewed By Approved By
Sign. with
Date.

9.0 SOP DISTRIBUTION:

Name of Department Department Code
Quality Assurance QA
Production PD
Quality Control QC
Microbiology MB
Maintenance & Engineering MD
Human Resource HR
Warehouse WH

10.0 REVISION AND HISTORY:

REV. NO. REASON FOR REVISION

00 New SOP

SOP/QA/001-F01.00 The document is covered under IPR of Sun Moon Pharmaceuticals Pvt. Ltd. and should not be reproduced without authorization