Standard Operating Procedure for Storage of Light-Sensitive Raw Materials in UV-Protected Areas
| Department | Warehouse / Quality Assurance |
|---|---|
| SOP No. | SOP/RM/111/2025 |
| Supersedes | SOP/RM/111/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 11/02/2025 |
| Effective Date | 15/02/2025 |
| Review Date | 11/02/2026 |
1. Purpose
This Standard Operating Procedure (SOP) defines the proper methods for handling and storing light-sensitive raw materials in UV-protected areas to prevent degradation and ensure compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all light-sensitive raw materials, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and reagents that require protection from light exposure during storage within the warehouse.
3. Responsibilities
- Warehouse Personnel: Store light-sensitive materials in designated UV-protected areas, monitor environmental conditions, and maintain records.
- Quality Assurance (QA): Verify compliance with storage conditions, conduct periodic audits, and approve corrective actions for deviations.
- Warehouse Manager: Oversee storage operations, ensure proper UV protection measures are in place, and train staff on handling protocols.
4. Accountability
The Warehouse Manager is accountable for ensuring that light-sensitive materials are stored under appropriate conditions. The QA Manager is responsible for verifying compliance with regulatory and pharmacopoeial standards.
5. Procedure
5.1 Identification and Classification of Light-Sensitive Materials
- Material Identification:
- Identify light-sensitive materials from supplier documentation such as the Certificate of Analysis (COA) and Material Safety Data Sheet (MSDS).
- Label materials clearly with “Light-Sensitive – Store in UV-Protected Area.”
- Document identification details in the Light-Sensitive Material Identification Log (Annexure-1).
5.2 Storage Requirements for Light-Sensitive Materials
- UV-Protected Storage:
- Store materials in UV-protected storage units or rooms equipped with UV-filtering lights and coverings.
- Ensure that packaging (e.g., amber glass, opaque containers) offers additional light protection.
- Document storage arrangements in the Light-Sensitive Material Storage Log (Annexure-2).
- Temperature and Humidity Control:
- Maintain storage temperatures between 15°C and 25°C, unless otherwise specified by the manufacturer.
- Keep relative humidity below 60% to prevent material degradation.
- Document environmental conditions in the Temperature and Humidity Monitoring Log (Annexure-3).
5.3 Handling of Light-Sensitive Materials
- Handling Procedures:
- Handle materials under subdued lighting or in areas with UV-filtering lights.
- Limit exposure to natural and artificial light during sampling, dispensing, and transport.
- Use covered carts or opaque containers for internal material transfers.
- Document handling activities in the Material Handling Log (Annexure-4).
5.4 Monitoring and Documentation
- UV Exposure Monitoring:
- Install UV light intensity meters in storage areas to continuously monitor light exposure.
- Conduct periodic inspections to ensure UV protection measures are intact.
- Document monitoring data in the UV Exposure Monitoring Log (Annexure-5).
- Calibration of Monitoring Devices:
- Calibrate UV light intensity meters and environmental monitoring devices at regular intervals as per manufacturer guidelines.
- Document calibration activities in the Calibration Log (Annexure-6).
5.5 Handling of Deviations in Storage Conditions
- Deviation Detection:
- Identify deviations such as UV light exposure, temperature fluctuations, or humidity variations through monitoring systems.
- Immediately isolate affected materials and evaluate the potential quality impact.
- Document deviations in the Deviation Log (Annexure-7).
- Corrective Actions:
- Implement corrective actions such as replacing faulty UV filters, adjusting environmental controls, or relocating materials.
- QA will assess material integrity and determine the need for further testing or disposal.
- Document corrective actions in the Corrective Action Log (Annexure-8).
5.6 Periodic Review and Compliance Monitoring
- Warehouse Inspections:
- Conduct regular inspections to verify UV protection measures and proper storage conditions.
- Document inspection findings in the Warehouse Inspection Log (Annexure-9).
- QA Compliance Audits:
- QA will perform audits to ensure compliance with storage protocols for light-sensitive materials.
- Document audit findings in the Compliance Audit Log (Annexure-10).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- COA: Certificate of Analysis
- MSDS: Material Safety Data Sheet
- UV: Ultraviolet
7. Documents
- Light-Sensitive Material Identification Log (Annexure-1)
- Light-Sensitive Material Storage Log (Annexure-2)
- Temperature and Humidity Monitoring Log (Annexure-3)
- Material Handling Log (Annexure-4)
- UV Exposure Monitoring Log (Annexure-5)
- Calibration Log (Annexure-6)
- Deviation Log (Annexure-7)
- Corrective Action Log (Annexure-8)
- Warehouse Inspection Log (Annexure-9)
- Compliance Audit Log (Annexure-10)
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: Light-Sensitive Material Identification Log
| Date | Material Name | Batch Number | Storage Requirement | Identified By |
|---|---|---|---|---|
| 11/02/2025 | Vitamin A Palmitate | VAP-2025-001 | Store in UV-Protected Area | Ravi Kumar |
Annexure-2: Light-Sensitive Material Storage Log
| Date | Material Name | Batch Number | Storage Area | Stored By |
|---|---|---|---|---|
| 11/02/2025 | Vitamin A Palmitate | VAP-2025-001 | UV-Protected Storage Room 1 | Sunita Sharma |
Annexure-3: Temperature and Humidity Monitoring Log
| Date | Storage Area | Temperature (°C) | Humidity (%) | Recorded By |
|---|---|---|---|---|
| 11/02/2025 | UV-Protected Storage Room 1 | 22°C | 45% | Ravi Kumar |
Annexure-4: Material Handling Log
| Date | Material Name | Batch Number | Handling Activity | Handled By |
|---|---|---|---|---|
| 11/02/2025 | Vitamin A Palmitate | VAP-2025-001 | Transferred to QC Lab | Anjali Mehta |
Annexure-5: UV Exposure Monitoring Log
| Date | Storage Area | UV Intensity (µW/cm²) | Recorded By |
|---|---|---|---|
| 11/02/2025 | UV-Protected Storage Room 1 | 0.2 µW/cm² | Ravi Kumar |
Annexure-6: Calibration Log
| Date | Device | Calibration Status | Calibrated By |
|---|---|---|---|
| 10/02/2025 | UV Light Meter 001 | Calibrated | Sunita Sharma |
Annexure-7: Deviation Log
| Date | Deviation | Action Taken | Reported By |
|---|---|---|---|
| 10/02/2025 | UV Exposure above threshold | Replaced UV filter | Ravi Kumar |
Annexure-8: Corrective Action Log
| Date | Issue | Corrective Action | Performed By |
|---|---|---|---|
| 10/02/2025 | Light-sensitive material exposed to natural light | Isolated material and conducted quality testing | Sunita Sharma |
Annexure-9: Warehouse Inspection Log
| Date | Area Inspected | Inspector | Findings | Corrective Actions |
|---|---|---|---|---|
| 11/02/2025 | UV-Protected Storage Room 1 | Anjali Mehta | No deviations found | N/A |
Annexure-10: Compliance Audit Log
| Date | Audit Type | Findings | Corrective Actions | Audited By |
|---|---|---|---|---|
| 12/02/2025 | Light-Sensitive Material Storage 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 |
| 11/02/2025 | 2.0 | Updated Storage Procedures and Monitoring Protocols | Regulatory Compliance | QA Head |