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

1. 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

1. 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).
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

1. 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

1. 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).
2. 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

1. 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).
2. 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

1. Warehouse Inspections:
   • Conduct regular inspections to verify UV protection measures and proper storage conditions.
   • Document inspection findings in the Warehouse Inspection Log (Annexure-9).
2. 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

1. Light-Sensitive Material Identification Log (Annexure-1)
2. Light-Sensitive Material Storage Log (Annexure-2)
3. Temperature and Humidity Monitoring Log (Annexure-3)
4. Material Handling Log (Annexure-4)
5. UV Exposure Monitoring Log (Annexure-5)
6. Calibration Log (Annexure-6)
7. Deviation Log (Annexure-7)
8. Corrective Action Log (Annexure-8)
9. Warehouse Inspection Log (Annexure-9)
10. 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