SOP for Labeling Requirements for Partially Used Raw Material Containers – V 2.0
Standard Operating Procedure for Labeling Requirements for Partially Used Raw Material Containers
| Department |
Warehouse / Quality Assurance / Production |
| SOP No. |
SOP/RM/150/2025 |
| Supersedes |
SOP/RM/150/2022 |
| Page No. |
Page 1 of 12 |
| Issue Date |
19/03/2025 |
| Effective Date |
26/03/2025 |
| Review Date |
19/03/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the labeling requirements for partially used raw material containers to ensure traceability, prevent cross-contamination, and maintain the integrity of materials in compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all personnel involved in the handling, labeling, and storage of partially used raw material containers in the warehouse and production areas. It covers primary, secondary, and tertiary labeling requirements for different types of raw materials, including APIs, excipients, and hazardous materials.
3. Responsibilities
- Warehouse Personnel: Ensure proper labeling of partially used containers after initial use and during storage.
- Production Team: Verify that materials returned from production to the warehouse are correctly labeled.
- Quality Assurance (QA): Review labeling practices, conduct audits, and ensure compliance with GMP.
- Warehouse Manager: Oversee the implementation of this SOP and ensure adequate labeling supplies are available.
4. Accountability
The Warehouse Manager is accountable for ensuring that all partially used raw material containers are correctly labeled and stored. The QA Manager is responsible for auditing and ensuring compliance with regulatory requirements.
5. Procedure
5.1 Labeling Requirements for Partially Used Containers
- Primary Label Requirements:
- Original manufacturer’s label must remain intact and legible.
- Ensure that batch number, material name, and expiry date are clearly visible.
- If the primary label is damaged, replace it immediately with a new label replicating the original information.
- Document primary label replacements in the Label Replacement Log (Annexure-1).
- Secondary Label Requirements:
- Attach a secondary label indicating the following:
- Date of first use
- Remaining quantity
- Name and signature of the person who used the material
- Storage conditions if different from the original label
- Use color-coded labels for quick identification of partially used materials.
- Document secondary labeling in the Secondary Label Log (Annexure-2).
- Tertiary Label Requirements (for Hazardous Materials):
- Include hazard symbols and safety precautions on the label.
- Indicate special storage or handling instructions if applicable.
- Ensure labels are waterproof and resistant to the stored material’s properties.
- Document hazardous material labeling in the Hazardous Material Label Log (Annexure-3).
5.2 Handling and Storage of Partially Used Containers
- Return to Warehouse:
- After partial use in production, return containers to the warehouse with proper labeling.
- Inspect the container for any signs of contamination or damage before returning it to storage.
- Document the return process in the Material Return Log (Annexure-4).
- Storage Conditions:
- Ensure partially used containers are stored according to the specified conditions on the label.
- Segregate partially used materials from full, unopened containers to prevent mix-ups.
- Document storage conditions in the Storage Log for Partially Used Materials (Annexure-5).
5.3 Periodic Review and Audit of Labels
- Monthly Label Review:
- Conduct monthly reviews of all partially used containers to ensure labeling compliance.
- Identify and correct any labeling discrepancies immediately.
- Document monthly reviews in the Label Review Log (Annexure-6).
- Audit Procedure:
- QA will conduct quarterly audits to verify proper labeling and storage of partially used materials.
- Non-compliance issues will be addressed with corrective and preventive actions (CAPA).
- Document audit findings in the Label Audit Log (Annexure-7).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- CAPA: Corrective and Preventive Action
7. Documents
- Label Replacement Log (Annexure-1)
- Secondary Label Log (Annexure-2)
- Hazardous Material Label Log (Annexure-3)
- Material Return Log (Annexure-4)
- Storage Log for Partially Used Materials (Annexure-5)
- Label Review Log (Annexure-6)
- Label Audit Log (Annexure-7)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- WHO Guidelines on Good Manufacturing Practices for Pharmaceutical Products
- OSHA Hazard Communication Standards
9. SOP Version
Version: 2.0
10. Approval Section
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Approved By |
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Annexure-1: Label Replacement Log
| Date |
Material Name |
Batch Number |
Reason for Replacement |
Replaced By |
Verified By |
| 19/03/2025 |
Citric Acid |
CA-5678 |
Original label damaged during handling |
Ravi Kumar |
Neha Verma |
| 19/03/2025 |
Sodium Hydroxide |
NAOH-2345 |
Label faded due to exposure to light |
Amit Joshi |
Priya Singh |
Annexure-2: Secondary Label Log
| Date |
Material Name |
Batch Number |
Date of First Use |
Remaining Quantity |
Labeled By |
| 19/03/2025 |
Glucose Monohydrate |
GM-9876 |
17/03/2025 |
25 kg |
Ravi Kumar |
| 19/03/2025 |
Potassium Chloride |
KCL-4567 |
15/03/2025 |
15 kg |
Amit Joshi |
Annexure-3: Hazardous Material Label Log
| Date |
Material Name |
Batch Number |
Hazard Symbols Applied |
Special Handling Instructions |
Labeled By |
| 19/03/2025 |
Hydrochloric Acid |
HCL-1234 |
Corrosive, Toxic |
Use PPE; store in acid-resistant container |
Neha Verma |
| 19/03/2025 |
Sodium Hypochlorite |
SH-7890 |
Irritant, Oxidizer |
Store in a cool, ventilated area |
Priya Singh |
Annexure-4: Material Return Log
| Date |
Material Name |
Batch Number |
Quantity Returned |
Returned By |
Inspected By |
| 19/03/2025 |
Magnesium Stearate |
MS-4321 |
10 kg |
Amit Joshi |
Neha Verma |
| 19/03/2025 |
Lactose Monohydrate |
LM-6543 |
5 kg |
Ravi Kumar |
Priya Singh |
Annexure-5: Storage Log for Partially Used Materials
| Date |
Material Name |
Batch Number |
Storage Location |
Storage Conditions |
Stored By |
| 19/03/2025 |
Calcium Carbonate |
CC-9876 |
Rack A2 |
Room temperature, dry area |
Ravi Kumar |
| 19/03/2025 |
Aspartame |
ASP-5432 |
Rack B1 |
Cool, dark storage |
Neha Verma |
Annexure-6: Label Review Log
| Date |
Reviewer Name |
Materials Reviewed |
Issues Identified |
Corrective Actions Taken |
Status |
| 19/03/2025 |
Priya Singh |
Citric Acid, Magnesium Stearate |
Label wear due to moisture exposure |
Replaced with waterproof labels |
Resolved |
| 19/03/2025 |
Neha Verma |
Hydrochloric Acid, Sodium Hypochlorite |
Missing hazard symbols on one container |
Updated with appropriate symbols |
Resolved |
Annexure-7: Label Audit Log
| Date |
Auditor Name |
Area Audited |
Findings |
Corrective Actions |
Audit Status |
| 19/03/2025 |
Amit Joshi |
Warehouse Rack A1 |
Secondary labels missing on two containers |
Secondary labels applied immediately |
Closed |
| 19/03/2025 |
Priya Singh |
Hazardous Material Storage |
Inconsistent font size on warning labels |
Standardized labeling format applied |
Closed |
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 |
| 19/03/2025 |
2.0 |
Updated labeling requirements for hazardous materials |
To align with revised GMP guidelines |
QA Head |