and tracking of batch numbers across all manufacturing and quality-related documents.

3. Responsibilities

• QA Department: Responsible for generation, approval, and control of batch numbers. Maintains master logbook.
• Production Department: Requests batch numbers and ensures proper documentation in all batch-related records.
• QC Department: Verifies batch number in samples, CoA, and analytical records.

4. Accountability

The Head of QA is accountable for ensuring that the batch number generation and control system is implemented consistently and that batch traceability is maintained.

5. Procedure

5.1 Batch Number Format

1. Batch numbers shall be generated using the following format: [Product Code]/[YYMM]/[Serial Number]
   Example: API01/2504/001 where:
   • API01 = Unique Product Code assigned by QA
   • 2504 = Year (2025) and Month (April)
   • 001 = Serial number starting from 001 for each month

5.2 Batch Number Request and Approval

1. Production shall request batch numbers using the Batch Number Request Form (Annexure-1).
2. QA shall verify:
   • Product name and code
   • Manufacturing schedule
   • Material planning confirmation
3. QA shall assign batch numbers and record details in the Batch Number Issuance Register (Annexure-2).

5.3 Control of Batch Numbers

1. Each batch number must be:
   • Unique and non-repetitive
   • Pre-approved before use
   • Linked to a specific manufacturing BMR
2. No batch number shall be used without QA issuance and authorization.
3. In case of batch cancellation, the number shall be marked as “Cancelled” with reason.

5.4 Batch Number Usage and Tracking

1. Batch number must appear on:
   • Batch Manufacturing Record (BMR)
   • In-process sampling labels
   • QC test reports
   • Packing and labeling materials
   • Release documents and CoA
2. Each step must ensure that the batch number is consistent across all associated documentation.

5.5 Electronic Batch Number Systems (if applicable)

1. If batch numbers are managed in an ERP or LIMS:
   • Only authorized QA personnel shall have access rights for generation
   • System audit trail must be enabled
   • Electronic batch numbers must sync with physical BMR

5.6 Batch Number Review and Audit

1. QA shall conduct quarterly audits of batch number issuance and traceability.
2. Verify against production and release records.
3. Any discrepancy must be investigated using the Batch Number Discrepancy Form (Annexure-3).

6. Abbreviations

• API: Active Pharmaceutical Ingredient
• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• QC: Quality Control
• LIMS: Laboratory Information Management System
• ERP: Enterprise Resource Planning

7. Documents

1. Batch Number Request Form (Annexure-1)
2. Batch Number Issuance Register (Annexure-2)
3. Batch Number Discrepancy Form (Annexure-3)

8. References

• ICH Q7 – GMP for APIs
• 21 CFR Part 211.105 – Equipment identification
• EU GMP Part II – Section 5 and 6

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 Number Request Form

Product Name	Product Code	Requested By	Date
API-X	API01	Rajesh Kumar	10/04/2025

Annexure-2: Batch Number Issuance Register

Batch No.	Product Code	Issued By	Issue Date	Status
API01/2504/001	API01	Sunita Reddy	11/04/2025	Active

Annexure-3: Batch Number Discrepancy Form

Batch No.	Discrepancy Description	Investigation Summary	Action Taken
API01/2504/004	Mismatch in CoA and BMR	Typographical error	Corrected and retrained staff

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Version	New SOP	QA Head
14/04/2025	2.0	Included ERP/LIMS usage	System integration	QA Head