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

• Warehouse Personnel: Ensure proper handling and storage of allergens and high-risk materials according to this SOP.
• Warehouse Manager: Oversee dedicated storage areas and ensure compliance with storage requirements.
• Quality Assurance (QA): Monitor storage conditions, conduct audits, and verify compliance with GMP standards.

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).

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).

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

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• MSDS: Material Safety Data Sheet
• PPE: Personal Protective Equipment

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

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• WHO GMP Guidelines
• OSHA Hazardous Material Handling Standards

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