SOP Guide for Pharma

SOP for Storage of Light-Sensitive Raw Materials in UV-Protected Areas – V 2.0

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SOP for Storage of Light-Sensitive Raw Materials in UV-Protected Areas – V 2.0

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

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).
See also  SOP for Coordination Between Logistics and Warehouse Teams for Receipt of Raw Materials - V 2.0

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).
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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

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

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
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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
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