SOP for Identification and Management of High-Risk Raw Materials in Storage – V 2.0
Standard Operating Procedure for Identification and Management of High-Risk Raw Materials in Storage
| Department |
Warehouse / Quality Assurance / Safety Department |
| SOP No. |
SOP/RM/141/2025 |
| Supersedes |
SOP/RM/141/2022 |
| Page No. |
Page 1 of 15 |
| Issue Date |
10/03/2025 |
| Effective Date |
17/03/2025 |
| Review Date |
10/03/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the procedures for the identification, classification, storage, and management of high-risk raw materials, ensuring compliance with Good Manufacturing Practices (GMP) and safety regulations.
2. Scope
This SOP applies to all high-risk raw materials, including but not limited to hazardous chemicals, flammable substances, toxic materials, and materials requiring special storage conditions within the warehouse facility.
3. Responsibilities
- Warehouse Personnel: Identify and manage high-risk materials according to safety protocols and storage requirements.
- Safety Officer: Ensure proper classification of high-risk materials and conduct safety training sessions.
- Warehouse Manager: Supervise the storage and management of high-risk materials, ensuring compliance with this SOP.
- Quality Assurance (QA): Review documentation and ensure compliance with GMP and safety standards.
4. Accountability
The Warehouse Manager and Safety Officer are accountable for the safe identification and management of high-risk raw materials. The QA Manager is responsible for reviewing documentation and ensuring compliance with GMP standards.
5. Procedure
5.1 Identification and Classification
- Initial Identification:
- Review the Safety Data Sheets (SDS) provided by the supplier to classify materials as high-risk based on toxicity, flammability, reactivity, or environmental hazards.
- Label materials with hazard symbols according to the Globally Harmonized System (GHS) standards.
- Document the classification in the High-Risk Material Identification Log (Annexure-1).
- Periodic Review:
- Review high-risk material classifications quarterly to ensure they meet current safety standards.
- Update labels and documentation as necessary based on new safety information.
5.2 Storage and Handling Procedures
- Designated Storage Areas:
- Store high-risk materials in designated, clearly marked areas with restricted access.
- Ensure that flammable and reactive materials are stored separately in compliance with safety guidelines.
- Document storage conditions in the High-Risk Material Storage Log (Annexure-2).
- Personal Protective Equipment (PPE):
- Ensure all personnel handling high-risk materials are equipped with appropriate PPE, including gloves, goggles, and respirators.
- Record PPE usage in the PPE Compliance Log (Annexure-3).
5.3 Risk Mitigation and Emergency Procedures
- Risk Assessment:
- Conduct risk assessments for all high-risk materials, identifying potential hazards and implementing control measures.
- Document risk assessments in the Risk Assessment Log (Annexure-4).
- Emergency Response:
- Develop emergency procedures for handling spills, exposures, or fires involving high-risk materials.
- Ensure all personnel are trained in emergency response protocols.
- Document emergency drills and responses in the Emergency Response Log (Annexure-5).
5.4 Documentation and Review
- Record-Keeping Requirements:
- Maintain all records related to the identification, storage, and management of high-risk materials for a minimum of five years.
- Ensure records are available for regulatory inspections and internal audits.
- Document record retention in the Record Retention Log (Annexure-6).
- Review and Continuous Improvement:
- QA and Safety Officers shall review high-risk material management procedures quarterly and recommend improvements as needed.
- Document review findings in the Management Review Log (Annexure-7).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- PPE: Personal Protective Equipment
- SDS: Safety Data Sheet
- GHS: Globally Harmonized System of Classification and Labeling of Chemicals
7. Documents
- High-Risk Material Identification Log (Annexure-1)
- High-Risk Material Storage Log (Annexure-2)
- PPE Compliance Log (Annexure-3)
- Risk Assessment Log (Annexure-4)
- Emergency Response Log (Annexure-5)
- Record Retention Log (Annexure-6)
- Management Review Log (Annexure-7)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- OSHA Hazard Communication Standard (29 CFR 1910.1200)
- WHO GMP Guidelines
- Globally Harmonized System of Classification and Labeling of Chemicals (GHS)
9. SOP Version
Version: 2.0
10. Approval Section
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11. Annexures
Annexure-1: High-Risk Material Identification Log
| Date |
Material Name |
Classification (Flammable/Toxic/Reactive) |
Batch Number |
Identified By |
| 10/03/2025 |
Acetone |
Flammable |
ACT-1234 |
Ravi Kumar |
Annexure-2: High-Risk Material Storage Log
| Date |
Material Name |
Batch Number |
Storage Location |
Storage Conditions |
Stored By |
| 10/03/2025 |
Acetone |
ACT-1234 |
Flammable Storage Cabinet A1 |
Temperature: 20°C, Ventilated |
Ravi Kumar |
| 10/03/2025 |
Hydrochloric Acid |
HCL-5678 |
Corrosive Materials Room B3 |
Temperature: 22°C, Isolated from bases |
Neha Verma |
Annexure-3: PPE Compliance Log
| Date |
Employee Name |
Material Handled |
PPE Used |
Compliance Status |
Checked By |
| 10/03/2025 |
Amit Joshi |
Acetone |
Gloves, Respirator, Safety Goggles |
Compliant |
Priya Singh |
| 10/03/2025 |
Neha Verma |
Hydrochloric Acid |
Chemical-Resistant Apron, Gloves, Face Shield |
Compliant |
Ravi Kumar |
Annexure-4: Risk Assessment Log
| Date |
Material Name |
Risk Identified |
Severity Level |
Control Measures Implemented |
Assessed By |
| 10/03/2025 |
Acetone |
Flammability risk near heat sources |
High |
Stored in flammable cabinet, away from ignition |
Priya Singh |
| 10/03/2025 |
Hydrochloric Acid |
Corrosive risk to skin and eyes |
Medium |
Use of PPE and isolated storage |
Ravi Kumar |
Annexure-5: Emergency Response Log
| Date |
Emergency Type |
Material Involved |
Response Actions Taken |
Outcome |
Reported By |
| 10/03/2025 |
Spill |
Acetone |
Evacuated area, used spill kit, ventilated room |
Area cleared and material safely contained |
Neha Verma |
| 10/03/2025 |
Exposure |
Hydrochloric Acid |
Administered first aid, flushed skin with water |
Minor injury, no further action required |
Amit Joshi |
Annexure-6: Record Retention Log
| Date |
Document Name |
Retention Period |
Stored By |
Storage Location |
| 10/03/2025 |
High-Risk Material Storage Log |
5 Years |
Priya Singh (QA) |
Document Control Room A |
| 10/03/2025 |
Emergency Response Log |
5 Years |
Ravi Kumar |
Document Control Room B |
Annexure-7: Management Review Log
| Date |
Review Type |
Findings |
Recommendations |
Reviewed By |
| 10/03/2025 |
Quarterly Review |
Improper segregation of flammable and corrosive materials |
Rearrange storage areas, reinforce training |
Priya Singh (QA) |
| 10/03/2025 |
Annual Review |
PPE compliance satisfactory, minor labeling issues |
Standardize hazard labeling procedures |
Ravi Kumar |
Revision History:
| Revision Date |
Revision No. |
Revision Details |
Reason for Revision |
Approved By |
| 01/01/2024 |
1.0 |
Initial Version |
New SOP Implementation |
QA Head |
| 10/03/2025 |
2.0 |
Updated risk management protocols and emergency procedures |
Alignment with updated GMP and OSHA guidelines |
QA Head |