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 |