SOP Guide for Pharma

SOP for Dedicated Storage for Allergens and High-Risk Raw Materials – V 2.0

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SOP for Dedicated Storage for Allergens and High-Risk Raw Materials – V 2.0

Standard Operating Procedure for Dedicated Storage for Allergens and High-Risk Raw Materials

Department Warehouse / Quality Assurance
SOP No. SOP/RM/122/2025
Supersedes SOP/RM/122/2022
Page No. Page 1 of 15
Issue Date 21/02/2025
Effective Date 25/02/2025
Review Date 21/02/2026

1. Purpose

This Standard Operating Procedure (SOP) provides guidelines for the safe handling and dedicated storage of allergens and high-risk raw materials to prevent cross-contamination and ensure regulatory compliance.

2. Scope

This SOP applies to all allergens (e.g., lactose, gluten) and high-risk raw materials (e.g., potent APIs, hazardous chemicals) stored in the warehouse.

3. Responsibilities

4. Accountability

The Warehouse Manager is accountable for implementing dedicated storage procedures, while the QA Manager ensures compliance with regulatory and safety requirements.

5. Procedure

5.1 Identification and Classification

  1. Allergen Identification:
    • Identify raw materials classified as allergens based on regulatory guidelines and manufacturer specifications.
    • Examples include lactose, gluten, soy, nuts, and shellfish-derived ingredients.
    • Record allergen materials in the Allergen Register (Annexure-1).
  2. High-Risk Material Classification:
    • Classify high-risk materials such as potent APIs, hazardous chemicals, and volatile solvents.
    • Refer to the Material Safety Data Sheets (MSDS) for risk classification.
    • Document high-risk materials in the High-Risk Material Register (Annexure-2).
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5.2 Dedicated Storage Areas

  1. Storage Requirements for Allergens:
    • Store allergens in designated, clearly labeled storage areas to prevent cross-contamination.
    • Use separate shelving units and ensure physical barriers between allergens and non-allergens.
    • Document allergen storage locations in the Allergen Storage Log (Annexure-3).
  2. Storage Requirements for High-Risk Materials:
    • Store high-risk materials in secure, ventilated, and temperature-controlled environments.
    • Use explosion-proof storage cabinets for volatile substances and locked areas for hazardous chemicals.
    • Document storage conditions in the High-Risk Material Storage Log (Annexure-4).

5.3 Labeling and Segregation

  1. Allergen Labeling:
    • Clearly label allergen materials with “ALLERGEN” tags, including material name, batch number, and expiry date.
    • Use color-coded labels (e.g., red for allergens) for easy identification.
    • Document label verification in the Allergen Label Log (Annexure-5).
  2. High-Risk Material Labeling:
    • Label high-risk materials with hazard symbols, storage instructions, and handling precautions.
    • Ensure all labels comply with regulatory and safety guidelines.
    • Record label verification in the High-Risk Material Label Log (Annexure-6).
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5.4 Handling Procedures

  1. Handling Allergens:
    • Handle allergens with designated equipment to prevent cross-contact with non-allergenic materials.
    • Use Personal Protective Equipment (PPE) and clean tools thoroughly after use.
    • Document handling activities in the Allergen Handling Log (Annexure-7).
  2. Handling High-Risk Materials:
    • Use appropriate PPE, including gloves, goggles, and respirators, when handling high-risk materials.
    • Follow MSDS instructions for safe handling and emergency procedures.
    • Document handling procedures in the High-Risk Material Handling Log (Annexure-8).

5.5 Monitoring and Audits

  1. Daily Monitoring:
    • Warehouse personnel must check storage conditions daily for allergens and high-risk materials.
    • Document daily monitoring in the Daily Storage Monitoring Log (Annexure-9).
  2. QA Audits:
    • QA will conduct monthly audits of dedicated storage areas to ensure compliance with GMP.
    • Record audit findings in the QA Audit Log (Annexure-10).

5.6 Handling Deviations and Corrective Actions

  1. Deviation Identification:
    • Identify deviations such as improper labeling, incorrect storage, or cross-contamination risks.
    • Immediately report deviations to the Warehouse Manager and QA.
    • Document deviations in the Deviation Log (Annexure-11).
  2. Corrective Actions:
    • Investigate root causes and implement corrective actions such as relabeling, re-segregating materials, or retraining staff.
    • Document corrective actions in the Corrective Action Log (Annexure-12).

6. Abbreviations

See also  SOP for Prevention of Infestation in Raw Material Storage Areas - V 2.0

7. Documents

  1. Allergen Register (Annexure-1)
  2. High-Risk Material Register (Annexure-2)
  3. Allergen Storage Log (Annexure-3)
  4. High-Risk Material Storage Log (Annexure-4)
  5. Allergen Label Log (Annexure-5)
  6. High-Risk Material Label Log (Annexure-6)
  7. Allergen Handling Log (Annexure-7)
  8. High-Risk Material Handling Log (Annexure-8)
  9. Daily Storage Monitoring Log (Annexure-9)
  10. QA Audit Log (Annexure-10)
  11. Deviation Log (Annexure-11)
  12. Corrective Action Log (Annexure-12)

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: Allergen Register

Date Material Name Batch Number Expiry Date Storage Condition
21/02/2025 Lactose Batch 101 21/02/2026 Room Temperature

Annexure-2: High-Risk Material Register

Date Material Name Batch Number Expiry Date Storage Condition
21/02/2025 API Potent X Batch 202 21/02/2026 2-8°C

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP QA Head
21/02/2025 2.0 Updated Handling and Storage Procedures Regulatory Compliance QA Head
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