Standard Operating Procedure for Handling and Storing Raw Materials With Biohazard Risks
| Department | Warehouse / Quality Assurance / Safety |
|---|---|
| SOP No. | SOP/RM/188/2025 |
| Supersedes | SOP/RM/188/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 23/04/2025 |
| Effective Date | 30/04/2025 |
| Review Date | 23/04/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the procedures for the safe handling, storage, and management of raw materials with biohazard risks, ensuring compliance with Good Manufacturing Practices (GMP) and biosafety standards.
2. Scope
This SOP applies to all warehouse personnel involved in the receipt, handling, storage, and disposal of biohazardous raw materials, including biological substances, cultures, and other potentially infectious materials.
3. Responsibilities
- Warehouse Personnel: Follow proper handling and storage procedures for biohazardous materials and use appropriate personal protective equipment (PPE).
- Quality Assurance (QA) Team: Ensure compliance with biosafety and GMP guidelines through regular audits and inspections.
- Safety Officer: Oversee the implementation of biosafety protocols and provide training to warehouse staff on biohazard handling.
4. Accountability
The Warehouse Manager is accountable for ensuring that biohazardous materials are handled and stored according to regulatory requirements. The QA Manager ensures compliance with GMP and biosafety standards, while the Safety Officer
is responsible for implementing and monitoring biosafety procedures.
5. Procedure
5.1 Identification and Labeling of Biohazardous Materials
- Material Identification:
- Ensure all biohazardous materials are properly identified upon receipt, with clear documentation of their biohazard classification.
- Document identification details in the Biohazard Material Identification Log (Annexure-1).
- Labeling Requirements:
- Affix biohazard labels to all containers, indicating the material name, biohazard level, and handling precautions.
- Record labeling activities in the Biohazard Labeling Log (Annexure-2).
5.2 Storage of Biohazardous Materials
- Designated Storage Areas:
- Store biohazardous materials in designated, secure areas with restricted access and proper ventilation.
- Document storage locations in the Biohazard Storage Log (Annexure-3).
- Environmental Controls:
- Maintain appropriate temperature and humidity levels for biohazardous materials, as specified by regulatory guidelines.
- Record environmental monitoring in the Biohazard Environmental Monitoring Log (Annexure-4).
5.3 Handling and Transport of Biohazardous Materials
- Use of Personal Protective Equipment (PPE):
- Ensure all personnel handling biohazardous materials wear appropriate PPE, including gloves, lab coats, face shields, and respirators as needed.
- Document PPE usage in the PPE Compliance Log (Annexure-5).
- Safe Transport Procedures:
- Transport biohazardous materials in sealed, leak-proof containers with secondary containment to prevent spills.
- Record transport activities in the Biohazard Transport Log (Annexure-6).
5.4 Spill Response and Waste Disposal
- Spill Response Procedures:
- Immediately contain and clean up spills of biohazardous materials using appropriate disinfectants and spill kits.
- Document spill incidents in the Biohazard Spill Log (Annexure-7).
- Waste Disposal:
- Dispose of biohazardous waste in accordance with local regulations, using autoclaving, incineration, or other approved methods.
- Record disposal activities in the Biohazard Waste Disposal Log (Annexure-8).
5.5 Training and Compliance Monitoring
- Biosafety Training:
- Provide regular training to warehouse staff on biosafety protocols, proper handling techniques, and emergency response procedures.
- Document training sessions in the Biohazard Training Log (Annexure-9).
- Compliance Monitoring:
- Conduct periodic audits to ensure compliance with biosafety guidelines and update procedures as necessary.
- Record audit results in the Biohazard Compliance Audit Log (Annexure-9).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- PPE: Personal Protective Equipment
- CDC: Centers for Disease Control and Prevention
- OSHA: Occupational Safety and Health Administration
7. Documents
- Biohazard Material Identification Log (Annexure-1)
- Biohazard Labeling Log (Annexure-2)
- Biohazard Storage Log (Annexure-3)
- Biohazard Environmental Monitoring Log (Annexure-4)
- PPE Compliance Log (Annexure-5)
- Biohazard Transport Log (Annexure-6)
- Biohazard Spill Log (Annexure-7)
- Biohazard Waste Disposal Log (Annexure-8)
- Biohazard Training Log (Annexure-9)
8. References
- CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL)
- OSHA Guidelines for Handling Biohazardous Materials
- WHO Laboratory Biosafety Manual
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
Annexure-1: Biohazard Material Identification Log
| Date | Material Name | Biohazard Level | Identified By |
|---|---|---|---|
| 23/04/2025 | Culture X | Biohazard Level 2 | Ravi Kumar |
Annexure-2: Biohazard Labeling Log
| Date | Material Name | Label Applied | Labeled By |
|---|---|---|---|
| 23/04/2025 | Culture X | Biohazard Level 2 Label | Neha Verma |
Annexure-3: Biohazard Storage Log
| Date | Material Name | Storage Location | Stored By |
|---|---|---|---|
| 23/04/2025 | Culture X | Biohazard Storage Room 1 | Amit Joshi |
Annexure-4: Biohazard Environmental Monitoring Log
| Date | Storage Area | Temperature (°C) | Humidity (%) | Checked By |
|---|---|---|---|---|
| 23/04/2025 | Biohazard Storage Room 1 | 4°C | 40% | Kiran Patel |
Annexure-5: PPE Compliance Log
| Date | Employee Name | PPE Used | Checked By |
|---|---|---|---|
| 23/04/2025 | Ravi Kumar | Gloves, Lab Coat, Face Shield | Safety Officer |
Annexure-6: Biohazard Transport Log
| Date | Material Name | From | To | Transported By |
|---|---|---|---|---|
| 23/04/2025 | Culture X | Receiving Area | Biohazard Storage Room 1 | Amit Joshi |
Annexure-7: Biohazard Spill Log
| Date | Material Name | Spill Description | Cleaned By |
|---|---|---|---|
| 23/04/2025 | Culture X | Minor spill during transfer | Neha Verma |
Annexure-8: Biohazard Waste Disposal Log
| Date | Material Name | Disposal Method | Disposed By |
|---|---|---|---|
| 23/04/2025 | Culture X | Autoclaved and incinerated | Kiran Patel |
Annexure-9: Biohazard Training Log
| Date | Employee Name | Training Topic | Trainer | Remarks |
|---|---|---|---|---|
| 23/04/2025 | Ravi Kumar | Biohazard Handling and Safety | Safety Officer | Completed Successfully |
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 |
| 23/04/2025 | 2.0 | Included detailed spill response and waste disposal procedures. | Regulatory Update | QA Head |