Standard Operating Procedure for Labeling Requirements for Raw Materials in Warehouse
| Department | Warehouse / Quality Assurance |
|---|---|
| SOP No. | SOP/RM/104/2025 |
| Supersedes | SOP/RM/104/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 04/02/2025 |
| Effective Date | 08/02/2025 |
| Review Date | 04/02/2026 |
1. Purpose
This Standard Operating Procedure (SOP) defines the labeling requirements for raw materials stored in the warehouse. It ensures proper identification, traceability, and compliance with Good Manufacturing Practices (GMP) to prevent mix-ups and cross-contamination.
2. Scope
This SOP applies to all raw materials received and stored in the warehouse, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and other chemicals. It covers labeling standards, color codes, and documentation procedures.
3. Responsibilities
- Warehouse Personnel: Ensure all raw materials are accurately labeled upon receipt and throughout storage. Maintain labeling records.
- Quality Assurance (QA): Verify labeling compliance during audits and inspections. Approve changes in labeling formats.
- Warehouse Manager: Supervise labeling practices, ensure training of warehouse staff, and address labeling discrepancies.
4. Accountability
The Warehouse Manager is accountable for ensuring all raw materials are properly labeled in accordance with this SOP. The QA Manager is responsible for verifying labeling compliance during audits.
5. Procedure
5.1 Labeling Requirements
- Information to be Included on Labels:
- Material Name
- Batch/Lot Number
- Supplier Name
- Manufacturing Date
- Expiry Date or Retest Date
- Storage Conditions (if applicable)
- Status (Approved, Quarantined, Rejected)
- Label Placement:
- Labels must be securely affixed to each container in a visible location.
- Ensure that labels are not damaged, obscured, or detached during handling and storage.
5.2 Color-Coding of Labels
- Approved Materials:
- Green labels indicating “APPROVED.”
- Quarantined Materials:
- Yellow labels indicating “QUARANTINE.”
- Rejected Materials:
- Red labels indicating “REJECTED.”
5.3 Labeling Procedures
- Initial Labeling at Receipt:
- Upon receipt, warehouse personnel must label all raw materials with the required information and status.
- Document labeling activities in the Labeling Log (Annexure-1).
- Relabeling Due to Status Changes:
- When a material’s status changes (e.g., from Quarantine to Approved), update the label accordingly.
- Ensure old labels are removed or clearly marked as obsolete.
- Document relabeling activities in the Status Change Log (Annexure-2).
5.4 Handling of Damaged or Illegible Labels
- Inspection of Labels:
- Warehouse personnel must regularly inspect labels for damage or illegibility.
- Report any discrepancies to the Warehouse Manager and QA.
- Replacement of Labels:
- Replace damaged or illegible labels immediately, ensuring the correct information is applied.
- Document label replacements in the Label Replacement Log (Annexure-3).
5.5 Periodic Review and Compliance Monitoring
- Warehouse Inspections:
- Conduct periodic inspections to verify correct labeling of all materials.
- Record inspection findings in the Warehouse Inspection Log (Annexure-4).
- QA Compliance Audits:
- QA will conduct periodic audits to ensure labeling practices meet GMP standards.
- Document audit findings in the Compliance Audit Log (Annexure-5).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
7. Documents
- Labeling Log (Annexure-1)
- Status Change Log (Annexure-2)
- Label Replacement Log (Annexure-3)
- Warehouse Inspection Log (Annexure-4)
- Compliance Audit Log (Annexure-5)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- WHO GMP Guidelines
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Labeling Log
| Date | Material Name | Batch Number | Status | Labeled By |
|---|---|---|---|---|
| 04/02/2025 | API-X | API-X-2025-001 | Quarantine | Ravi Kumar |
Annexure-2: Status Change Log
| Date | Material Name | Batch Number | Previous Status | New Status | Changed By |
|---|---|---|---|---|---|
| 05/02/2025 | API-X | API-X-2025-001 | Quarantine | Approved | Anjali Mehta |
Annexure-3: Label Replacement Log
| Date | Material Name | Batch Number | Reason for Replacement | Replaced By |
|---|---|---|---|---|
| 06/02/2025 | API-X | API-X-2025-001 | Damaged Label | Sunita Sharma |
Annexure-4: Warehouse Inspection Log
| Date | Area Inspected | Inspector | Findings | Corrective Actions |
|---|---|---|---|---|
| 07/02/2025 | Raw Material Storage Area | Anjali Mehta | All labels intact | N/A |
Annexure-5: Compliance Audit Log
| Date | Audit Type | Findings | Corrective Actions | Audited By |
|---|---|---|---|---|
| 08/02/2025 | Labeling Compliance Audit | Compliant | N/A | Anjali Mehta |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 04/02/2025 | 2.0 | Updated Labeling Requirements and Documentation Formats | Regulatory Compliance | QA Head |