SOP for Ensuring Regulatory Compliance of Quarantine Storage – V 2.0

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SOP for Ensuring Regulatory Compliance of Quarantine Storage – V 2.0

Standard Operating Procedure for Ensuring Regulatory Compliance of Quarantine Storage

Department Quality Assurance / Quality Control / Warehouse
SOP No. SOP/RM/088/2025
Supersedes SOP/RM/088/2022
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 requirements and processes to ensure regulatory compliance for the storage of raw materials in the quarantine area. It aims to maintain material integrity, prevent contamination, and comply with Good Manufacturing Practices (GMP) and regulatory standards.

2. Scope

This SOP applies to all raw materials stored in quarantine, including Active Pharmaceutical Ingredients (APIs), excipients, solvents, and temperature-sensitive materials, ensuring they are stored under conditions that meet regulatory guidelines.

3. Responsibilities

  • Warehouse Personnel: Ensure proper storage conditions, labeling, and segregation of quarantined materials.
  • Quality Control (QC): Monitor the condition of quarantined materials and verify compliance with storage requirements.
  • Quality Assurance (QA): Conduct regular audits, approve storage procedures, and ensure adherence to regulatory guidelines.

4. Accountability

The QA Manager is accountable for ensuring regulatory compliance of quarantine storage. The Warehouse Manager is responsible for the physical storage and condition of quarantined materials.

5. Procedure

5.1 Regulatory Requirements for Quarantine Storage

  1. Applicable Guidelines:
    • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
    • ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
    • WHO GMP Guidelines for Storage and Distribution of Pharmaceuticals
  2. Key Compliance Areas:
    • Controlled access to quarantine areas
    • Proper labeling and segregation of quarantined materials
    • Environmental monitoring (temperature, humidity)
    • Documentation and traceability of all stored materials
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5.2 Storage Area Requirements

  1. Designated Quarantine Area:
    • Quarantine storage must be physically segregated from approved and rejected materials.
    • Clearly label the area with “Quarantine” signs and restrict unauthorized access.
  2. Environmental Conditions:
    • Maintain temperature and humidity within specified limits for each material type.
    • Monitor and record environmental conditions using calibrated equipment (Annexure-1).
    • Ensure clean and sanitary conditions to prevent contamination.

5.3 Material Handling in Quarantine

  1. Labeling of Materials:
    • Label all quarantined materials with:
      • Material Name
      • Batch/Lot Number
      • “Under Quarantine” status
      • Storage conditions (if applicable)
  2. Segregation and Identification:
    • Segregate materials based on type (APIs, excipients, solvents) and risk category (hazardous, temperature-sensitive).
    • Use color-coded tags or labels for easy identification.

5.4 Environmental Monitoring and Control

  1. Temperature and Humidity Monitoring:
    • Monitor environmental conditions daily using data loggers or thermohygrometers.
    • Document readings in the Environmental Monitoring Log (Annexure-2).
  2. Deviation Handling:
    • Document temperature or humidity deviations in the Deviation Report (Annexure-3).
    • Investigate root causes and implement corrective actions (Annexure-4).

5.5 Documentation and Record-Keeping

  1. Storage Records:
    • Maintain detailed records of all quarantined materials, including batch numbers, storage conditions, and movement logs.
    • Document all entries in the Quarantine Storage Log (Annexure-5).
  2. Audit and Compliance Documentation:
    • QA conducts periodic audits of quarantine storage to ensure compliance with SOPs and regulatory requirements.
    • Document audit findings and corrective actions in the Audit Log (Annexure-6).
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5.6 Training and Compliance Monitoring

  1. Personnel Training:
    • All personnel involved in quarantine storage must be trained on regulatory compliance and SOP requirements.
    • Document training completion in the Training Log (Annexure-7).
  2. Regular Compliance Checks:
    • QA conducts regular inspections to verify adherence to quarantine procedures and regulatory guidelines.
    • Document compliance checks in the Compliance Check Log (Annexure-8).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • QC: Quality Control
  • APIs: Active Pharmaceutical Ingredients

7. Documents

  1. Environmental Monitoring Equipment Calibration Log (Annexure-1)
  2. Environmental Monitoring Log (Annexure-2)
  3. Deviation Report (Annexure-3)
  4. Corrective Action Log (Annexure-4)
  5. Quarantine Storage Log (Annexure-5)
  6. Audit Log (Annexure-6)
  7. Training Log (Annexure-7)
  8. Compliance Check Log (Annexure-8)

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 for Storage and Distribution of Pharmaceuticals

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 Equipment Calibration Log

Date Equipment Name Calibration Method Calibrated By Verified By (QA)
01/02/2025 Thermohygrometer Standard Calibration Ravi Kumar Anjali Mehta
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Annexure-2: Environmental Monitoring Log

Date Time Temperature (°C) Humidity (%) Recorded By
01/02/2025 09:00 AM 25°C 45% Sunita Sharma

Annexure-3: Deviation Report

Date Deviation Description Reported By Investigated By
02/02/2025 Temperature Exceeded 30°C Ajay Singh Ravi Kumar

Annexure-4: Corrective Action Log

Date Deviation Description Corrective Action Implemented By Verified By (QA)
03/02/2025 Temperature Exceeded 30°C Calibrated HVAC System Ravi Kumar Anjali Mehta

Annexure-5: Quarantine Storage Log

Date Material Name Batch Number Storage Location Stored By
01/02/2025 API-X API-X-2025-001 Quarantine Area A Ravi Kumar

Annexure-6: Audit Log

Date Audit Type Findings Corrective Actions Taken Audited By
04/02/2025 Quarantine Compliance Audit Temperature Monitoring Gap Updated Monitoring SOP Anjali Mehta

Annexure-7: Training Log

Date Training Topic Trainer Attendee Name Signature
05/02/2025 Quarantine Storage Compliance QA Manager Sunita Sharma

Annexure-8: Compliance Check Log

Date Compliance Check Findings Corrective Actions Checked By
06/02/2025 Environmental Monitoring Humidity Spike Adjusted HVAC Settings 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
01/02/2025 2.0 Updated Storage and Monitoring Procedures for Regulatory Compliance Regulatory Compliance QA Head
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