Standard Operating Procedure for Transporting Raw Materials from Receiving Area to Quarantine
| Department | Warehouse / Quality Assurance / Logistics |
|---|---|
| SOP No. | SOP/RM/062/2025 |
| Supersedes | SOP/RM/062/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 01/02/2025 |
| Effective Date | 05/02/2025 |
| Review Date | 01/02/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the process for safely transporting raw materials from the receiving area to the quarantine area. It ensures materials are moved without contamination or damage and maintains compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all raw materials, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and packaging materials, received at the facility that require transportation to quarantine before quality approval.
3. Responsibilities
- Warehouse Personnel: Ensure proper handling and transportation of raw materials from the receiving area to the quarantine zone.
- Logistics Team: Utilize appropriate transportation equipment and ensure the integrity of materials during movement.
- Quality Assurance (QA): Oversee compliance with GMP during material transportation and approve any deviations from standard procedures.
4. Accountability
The Warehouse Manager is responsible for ensuring that materials are transported safely from the receiving area to quarantine. The Logistics Manager ensures the proper use of
transportation equipment, while the QA Manager ensures all transportation complies with regulatory and safety guidelines.
5. Procedure
5.1 Preparation for Material Transportation
-
Verification at Receiving Area:
- Verify the material against the delivery documentation (Purchase Order, Delivery Note).
- Check packaging for any visible damage or signs of tampering.
- Label materials as “UNDER TEST” before transportation to the quarantine area.
- Document verification in the Material Transportation Log (Annexure-1).
-
Preparation of Transport Equipment:
- Ensure transportation equipment (trolleys, forklifts) is clean and suitable for the type of material being moved.
- For temperature-sensitive materials, use temperature-controlled transportation if required.
5.2 Material Transportation Process
-
Loading Procedures:
- Load materials carefully to prevent any physical damage or spillage.
- Ensure materials are securely positioned to avoid shifting during transportation.
-
Transportation Route:
- Use designated pathways for transporting raw materials to minimize cross-contamination risks.
- Avoid areas with high foot traffic or exposure to other raw materials.
- Ensure continuous monitoring during transportation for hazardous or sensitive materials.
-
Unloading Procedures:
- Unload materials carefully in the quarantine area without compromising packaging integrity.
- Segregate materials in the quarantine area according to type, testing status, and hazard classification.
- Document unloading details in the Quarantine Receiving Log (Annexure-2).
5.3 Handling Special Categories of Raw Materials
-
Temperature-Sensitive Materials:
- Transport using temperature-controlled equipment and ensure minimal exposure to ambient conditions.
- Verify temperature data loggers post-transport to confirm no deviations occurred.
-
Hazardous or Volatile Materials:
- Transport hazardous materials in compliance with safety protocols using flameproof or explosion-proof equipment if required.
- Ensure emergency spill kits and fire extinguishers are readily available during transportation.
5.4 Documentation and Record-Keeping
-
Transportation Documentation:
- Complete the Material Transportation Log, ensuring the following details are recorded:
- Material name and batch number.
- Date and time of transportation.
- Personnel involved in transportation.
- Any incidents or observations during transportation.
- Complete the Material Transportation Log, ensuring the following details are recorded:
-
QA Review:
- QA reviews transportation logs to ensure compliance with procedures.
- Record any deviations or corrective actions in the Transportation Deviation Report (Annexure-3).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- API: Active Pharmaceutical Ingredient
- QA: Quality Assurance
7. Documents
- Material Transportation Log (Annexure-1)
- Quarantine Receiving Log (Annexure-2)
- Transportation Deviation Report (Annexure-3)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- EU Guidelines on Good Distribution Practices (GDP)
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Material Transportation Log
| Date | Material Name | Batch Number | Transported By | Time of Transport | Remarks |
|---|---|---|---|---|---|
| 01/02/2025 | API-X | X-2025-001 | Ravi Kumar | 10:00 AM | No Issues Observed |
| 01/02/2025 | Excipient-Y | Y-2025-002 | Sunita Sharma | 11:30 AM | Handled with Temperature Control |
Annexure-2: Quarantine Receiving Log
| Date | Material Name | Batch Number | Received By | Quarantine Zone | Remarks |
|---|---|---|---|---|---|
| 01/02/2025 | API-X | X-2025-001 | Anil Mehta | Zone A | Properly Segregated |
| 01/02/2025 | Excipient-Y | Y-2025-002 | Ajay Singh | Zone B | No Damage Noted |
Annexure-3: Transportation Deviation Report
| Date | Material Name | Batch Number | Deviation Observed | Reported By | Corrective Action Taken |
|---|---|---|---|---|---|
| 01/02/2025 | Excipient-Y | Y-2025-002 | Temperature Fluctuation | Sunita Sharma | Material Placed Under Review |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Enhanced Transport Procedures and Documentation Requirements | Compliance Improvement | QA Head |