SOP for Verification of Raw Material Batch Number Before Issuance – V 2.0

Standard Operating Procedure for Verification of Raw Material Batch Number Before Issuance

Department	Warehouse / Production / Quality Assurance
SOP No.	SOP/RM/197/2025
Supersedes	SOP/RM/197/2022
Page No.	Page 1 of 15
Issue Date	02/05/2025
Effective Date	09/05/2025
Review Date	02/05/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for verifying raw material batch numbers before issuance to ensure accurate material identification, traceability, and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all warehouse, production, and quality assurance personnel involved in the verification, issuance, and documentation of raw materials in the pharmaceutical manufacturing process.

3. Responsibilities

Warehouse Staff: Verify batch numbers before issuing materials and document the verification process.
Production Supervisor: Ensure that only verified materials with correct batch numbers are used in production.
Quality Assurance (QA) Team: Oversee and audit the verification process for compliance with GMP.

4. Accountability

The Warehouse Manager is accountable for ensuring the correct verification of batch numbers before issuance. The Production Supervisor ensures compliance during material usage, while the QA Manager conducts audits to verify adherence to the SOP.

5. Procedure

5.1

Preparation for Batch Verification

Review of Batch Manufacturing Record (BMR):
- Ensure that the Batch Manufacturing Record (BMR) specifies the required batch numbers for raw materials.
- Document the BMR review in the BMR Review Log (Annexure-1).
Accessing Raw Material Storage:
- Retrieve raw materials from storage areas following First-In, First-Out (FIFO) or First-Expiry, First-Out (FEFO) principles.
- Record retrieval details in the Material Retrieval Log (Annexure-2).

5.2 Batch Number Verification Process

Physical Verification:
- Physically inspect the label on the raw material container to verify the batch number.
- Ensure that the batch number matches the BMR and purchase order details.
- Record the verification in the Batch Number Verification Log (Annexure-3).
Cross-Verification with Documentation:
- Cross-verify the batch number with the Certificate of Analysis (COA), Goods Receipt Note (GRN), and other relevant documents.
- Document the cross-verification in the Document Verification Log (Annexure-4).

5.3 Handling Discrepancies in Batch Verification

Identification of Discrepancies:
- If any discrepancies are found between the batch number on the raw material and the BMR, report immediately to QA.
- Document discrepancies in the Discrepancy Log (Annexure-5).
Corrective Actions:
- Take corrective actions as recommended by QA, such as re-verification or rejection of the material.
- Document corrective actions in the Corrective Action Log (Annexure-6).

5.4 Labeling and Issuance of Verified Materials

Labeling of Verified Materials:
- Label materials with “Verified” tags after successful batch number verification.
- Record labeling in the Labeling Log (Annexure-7).
Issuance of Verified Materials:
- Issue only verified materials to the production department as per the BMR.
- Document issuance details in the Material Issuance Log (Annexure-8).

5.5 Training and Compliance Audits

Training on Batch Verification:
- Conduct regular training sessions for warehouse and production staff on batch verification procedures.
- Document training in the Training Log (Annexure-9).
Compliance Audits:
- QA performs periodic audits to ensure compliance with batch verification procedures.
- Record audit findings in the Compliance Audit Log (Annexure-9).

6. Abbreviations

SOP: Standard Operating Procedure
BMR: Batch Manufacturing Record
QA: Quality Assurance
FIFO: First-In, First-Out
FEFO: First-Expiry, First-Out
COA: Certificate of Analysis
GRN: Goods Receipt Note

7. Documents

BMR Review Log (Annexure-1)
Material Retrieval Log (Annexure-2)
Batch Number Verification Log (Annexure-3)
Document Verification Log (Annexure-4)
Discrepancy Log (Annexure-5)
Corrective Action Log (Annexure-6)
Labeling Log (Annexure-7)
Material Issuance Log (Annexure-8)
Training Log (Annexure-9)

8. References

21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
WHO Guidelines on GMP for Pharmaceutical Products
FDA Guidance on Material Verification Procedures

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

Annexure-1: BMR Review Log

Date	BMR Number	Reviewed By	Remarks
02/05/2025	BMR-78945	Ravi Kumar	Reviewed and Approved

Annexure-2: Material Retrieval Log

Date	Material Name	Batch Number	Retrieved By
02/05/2025	Ibuprofen API	BN-12345	Neha Verma

Annexure-3: Batch Number Verification Log

Date	Material Name	Batch Number	Verified By
02/05/2025	Ibuprofen API	BN-12345	Amit Joshi

Annexure-4: Document Verification Log

Date	Document Type	Batch Number	Verified By
02/05/2025	COA	BN-12345	QA Team

Annexure-5: Discrepancy Log

Date	Discrepancy Identified	Description	Reported By
02/05/2025	Mismatched Batch Number	Batch on container does not match BMR	QA Team

Annexure-6: Corrective Action Log

Date	Issue	Corrective Action Taken	Performed By
02/05/2025	Mismatched Batch Number	Re-issued correct batch	Warehouse Staff

Annexure-7: Labeling Log

Date	Material Name	Label Information	Labeled By
02/05/2025	Ibuprofen API	Batch BN-12345, Verified	Ravi Kumar

Annexure-8: Material Issuance Log

Date	Material Name	Batch Number	Issued To
02/05/2025	Ibuprofen API	BN-12345	Production Department

Annexure-9: Training Log

Date	Employee Name	Training Topic	Trainer	Remarks
02/05/2025	Neha Verma	Batch Verification Procedures	QA Manager	Completed Successfully

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Implementation	QA Head
02/05/2025	2.0	Added cross-verification and discrepancy handling procedures.	Regulatory Update	QA Head