Standard Operating Procedure for Batch Number Assignment and Traceability in Tablets

Department	Tablet
SOP No.	SOP/TAB/186/2025
Supersedes	SOP/TAB/186/2022
Page No.	Page 1 of 6
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To establish a consistent and compliant process for assigning batch numbers to tablet products, ensuring full traceability of each batch throughout the manufacturing and distribution process.

2. Scope

This SOP applies to the assignment, tracking, and documentation of batch numbers for all tablet products manufactured at the facility, covering raw materials, production, packaging, and distribution.

3. Responsibilities

• Production Team: Responsible for assigning and recording batch numbers during the manufacturing process and ensuring proper documentation.
• Warehouse Team: Responsible for ensuring that batch numbers are accurately tracked during storage and distribution.
• Quality Assurance (QA): Responsible for overseeing the batch number assignment process, ensuring traceability, and ensuring compliance with regulatory guidelines.
• Regulatory Affairs: Responsible for ensuring batch number traceability in compliance with applicable regulations and guidelines.

4. Accountability

The QA Manager is accountable for ensuring proper batch number assignment, record-keeping, and traceability of tablets throughout the entire manufacturing process and distribution chain.

5. Procedure

5.1 Batch Number Assignment

1. Assign a unique batch number to each production run of tablets. The batch number should be formatted according to company standards and should include details such as:
   • Production date
   • Product code
   • Batch sequence number
2. Ensure that batch numbers are assigned prior to the start of production and are documented in the batch production record (Annexure-1).
3. Verify that all raw materials, intermediate products, and finished goods within a batch are assigned the same batch number for full traceability.

5.2 Batch Number Documentation

1. Document all batch number details in the Batch Production Record (BPR) and the Inventory System (Annexure-2).
2. Ensure that batch records contain the following information:
   • Batch number
   • Raw material batch numbers used
   • Manufacturing equipment used
   • Production dates
   • Employee names involved
3. Ensure that all batch documentation is completed accurately and signed off by the responsible personnel.

5.3 Traceability and Tracking

1. Ensure that batch numbers are used for tracking all tablet products through each stage of the manufacturing process, from raw material receipt to final product release.
2. All batch numbers must be recorded in the inventory management system, and the system should allow for real-time tracking of product movement through storage, packaging, and distribution.
3. Use batch numbers to trace products in case of a recall, customer complaint, or adverse event reporting.

5.4 Batch Number Verification

1. Verify the accuracy of batch numbers during the following stages:
   • Raw material receipt and inspection
   • During production, to ensure consistency with the batch records
   • During packaging, to ensure proper labeling and packaging of the final product
   • At dispatch, to ensure proper shipment of finished products
2. Ensure that batch numbers are recorded consistently in all relevant documentation, including shipping, receiving, and quality control logs.

5.5 Documentation and Record Keeping

1. Maintain batch number documentation for a minimum of five years or as required by regulatory guidelines (Annexure-3).
2. Ensure that batch records are available for inspection by regulatory authorities upon request.
3. Ensure that all batch records are signed, dated, and completed by the responsible personnel.

5.6 Reporting and Auditing

1. Report any issues related to batch number assignment, traceability, or discrepancies to senior management immediately.
2. Conduct regular audits to verify the accuracy of batch number documentation and traceability. Ensure corrective actions are taken if any discrepancies are identified.
3. Ensure compliance with internal audits and external regulatory inspections related to batch traceability.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• BPR: Batch Production Record
• FDA: Food and Drug Administration

7. Documents

1. Batch Production Record (BPR) (Annexure-1)
2. Inventory System Record (Annexure-2)
3. Batch Traceability Report (Annexure-3)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• ISO 9001 – Quality Management Systems
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Production Record (BPR)

Batch Number	Product Code	Raw Material Batch Number	Production Date	Quantity Produced	Employee Involved
Batch-12345	Tablet A	Batch-RM-123	01/03/2026	10,000 tablets	John Doe

Annexure-2: Inventory System Record

Batch Number	Material Name	Issued Quantity	Quantity Remaining
Batch-12345	Tablet A	10,000 tablets	0 tablets

Annexure-3: Batch Traceability Report

Batch Number	Start Date	End Date	Quantity Produced	Disposition
Batch-12345	01/03/2026	01/03/2026	10,000 tablets	Released

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated batch number assignment procedure	Clarified traceability and documentation requirements	QA Head