SOP for Storage Conditions in Quarantine for Different Types of Raw Materials – V 2.0

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SOP for Storage Conditions in Quarantine for Different Types of Raw Materials – V 2.0

Standard Operating Procedure for Storage Conditions in Quarantine for Different Types of Raw Materials

Department Warehouse / Quality Assurance / Quality Control
SOP No. SOP/RM/065/2025
Supersedes SOP/RM/065/2022
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 storage conditions required for different types of raw materials in the quarantine area to maintain their integrity and prevent contamination. It ensures 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 stored in the quarantine area before Quality Control (QC) testing and Quality Assurance (QA) approval.

3. Responsibilities

  • Warehouse Personnel: Ensure raw materials are stored under appropriate conditions in the quarantine area and monitor environmental parameters regularly.
  • Quality Assurance (QA): Verify compliance with storage conditions and approve any deviations from standard storage protocols.
  • Quality Control (QC): Conduct sampling and testing of quarantined materials, ensuring they meet quality standards after storage.

4. Accountability

The Warehouse Manager is responsible for maintaining proper storage conditions in the quarantine area. The QA Manager ensures

that storage conditions comply with GMP and regulatory requirements. The QC Manager verifies material integrity post-storage.

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5. Procedure

5.1 Storage Area Setup

  1. Designation of Storage Zones:

    • Segregate the quarantine area into specific zones based on material type and storage requirements:
      • Zone A: APIs
      • Zone B: Excipients
      • Zone C: Solvents and volatile substances
      • Zone D: Temperature-sensitive materials
      • Zone E: Hazardous materials
    • Clearly label each zone and ensure physical barriers between incompatible materials.
  2. Environmental Monitoring Setup:

    • Install temperature and humidity monitors in each storage zone.
    • Set alarm thresholds for deviations and maintain logs for temperature and humidity (Annexure-1).

5.2 Storage Conditions for Different Raw Materials

  1. APIs:

    • Store in a cool, dry place at temperatures between 15°C and 25°C.
    • Protect from light and moisture exposure using opaque containers and desiccants.
    • Record API storage conditions in the API Storage Log (Annexure-2).
  2. Excipients:

    • Store at ambient room temperature (20°C to 25°C) with controlled humidity (less than 50% RH).
    • Ensure containers are sealed tightly to prevent contamination.
    • Document excipient storage details in the Excipients Storage Log (Annexure-3).
  3. Solvents and Volatile Substances:

    • Store in flameproof cabinets or explosion-proof storage areas with proper ventilation.
    • Maintain temperatures between 5°C and 25°C as per the solvent specifications.
    • Log solvent storage information in the Solvent Storage Log (Annexure-4).
  4. Temperature-Sensitive Materials:

    • Store in temperature-controlled units (e.g., refrigerators or freezers) as specified:
      • Refrigerated materials: 2°C to 8°C
      • Frozen materials: -20°C or as specified
    • Monitor temperature using data loggers and record in the Temperature-Sensitive Materials Log (Annexure-5).
  5. Hazardous Materials:

    • Store separately from non-hazardous materials with proper hazard labeling.
    • Ensure materials are in leak-proof containers with spill containment measures in place.
    • Document hazardous material storage in the Hazardous Materials Log (Annexure-6).
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5.3 Monitoring and Documentation

  1. Routine Monitoring:

    • Warehouse personnel must monitor temperature and humidity twice daily and record values in the Environmental Monitoring Log (Annexure-1).
    • QA must review logs weekly to ensure compliance with storage requirements.
  2. Handling Deviations:

    • Any deviations from specified storage conditions must be immediately reported to QA.
    • Document deviations and corrective actions in the Storage Deviation Report (Annexure-7).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • API: Active Pharmaceutical Ingredient
  • QA: Quality Assurance
  • QC: Quality Control
  • RH: Relative Humidity

7. Documents

  1. Environmental Monitoring Log (Annexure-1)
  2. API Storage Log (Annexure-2)
  3. Excipients Storage Log (Annexure-3)
  4. Solvent Storage Log (Annexure-4)
  5. Temperature-Sensitive Materials Log (Annexure-5)
  6. Hazardous Materials Log (Annexure-6)
  7. Storage Deviation Report (Annexure-7)

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: Environmental Monitoring Log

Date Zone Temperature (°C) Humidity (%RH) Checked By Remarks
01/02/2025 Zone A (APIs) 22°C 45% Ravi Kumar Within Limits
01/02/2025 Zone C (Solvents) 20°C 50% Sunita Sharma No Issues
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Annexure-2: API Storage Log

Date Material Name Batch Number Storage Zone Stored By Remarks
01/02/2025 API-X X-2025-001 Zone A Anil Mehta Properly Stored

Annexure-3: Excipients Storage Log

Date Material Name Batch Number Storage Zone Stored By Remarks
01/02/2025 Excipient-Y Y-2025-002 Zone B Ajay Singh Humidity Controlled

Annexure-4: Solvent Storage Log

Date Material Name Batch Number Storage Zone Stored By Remarks
01/02/2025 Solvent-Z Z-2025-003 Zone C Priya Desai Stored in Flameproof Cabinet

Annexure-5: Temperature-Sensitive Materials Log

Date Material Name Batch Number Storage Temperature Stored By Remarks
01/02/2025 Reagent-A A-2025-004 4°C Anjali Mehta Temperature Controlled

Annexure-6: Hazardous Materials Log

Date Material Name Batch Number Hazard Class Stored By Remarks
01/02/2025 Chemical-B B-2025-005 Flammable Ramesh Patel Stored in Hazardous Zone

Annexure-7: Storage Deviation Report

Date Material Name Batch Number Deviation Observed Reported By Corrective Action Taken
02/02/2025 API-X X-2025-001 Temperature Fluctuation Ravi Kumar Material Relocated to Backup Storage

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 Updated Storage Zones and Monitoring Procedures Regulatory Compliance QA Head
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