shellfish-derived ingredients.

Record allergen materials in the Allergen Register (Annexure-1).

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