Standard Operating Procedure for Emergency Procedures for Handling Chemical Spills at Receiving
| Department | Warehouse / Quality Assurance / Health and Safety |
|---|---|
| SOP No. | SOP/RM/059/2025 |
| Supersedes | SOP/RM/059/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 01/02/2025 |
| Effective Date | 05/02/2025 |
| Review Date | 01/02/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the emergency procedures for safely handling chemical spills during the receiving of raw materials. It ensures the safety of personnel, prevents environmental contamination, and complies with Good Manufacturing Practices (GMP) and safety regulations.
2. Scope
This SOP applies to all chemical spills occurring during the receipt of raw materials at the facility. It includes procedures for managing spills of hazardous, flammable, corrosive, and toxic materials at the receiving dock and storage areas.
3. Responsibilities
- Warehouse Personnel: Identify and report chemical spills immediately, evacuate the area if needed, and assist in containment procedures as trained.
- Health and Safety Officer: Lead the spill response, ensure proper use of personal protective equipment (PPE), and oversee cleanup procedures.
- Quality Assurance (QA): Review spill reports, assess material integrity post-spill, and determine disposition.
- Procurement Department: Inform suppliers about spill incidents and coordinate corrective actions if due to supplier error.
4. Accountability
The Health and Safety Manager is responsible for ensuring that emergency spill procedures are implemented and personnel are trained. The Warehouse Manager ensures that spills are reported immediately, while the QA Manager assesses the impact of spills on material integrity. The Procurement Manager coordinates with suppliers if the spill is due to transportation or packaging failure.
5. Procedure
5.1 Immediate Response to Spills
-
Identify the Spill:
- Warehouse personnel must immediately identify the type and severity of the spill. Refer to the Material Safety Data Sheet (MSDS) for guidance.
- If the spill involves hazardous or flammable materials, activate the emergency alarm and evacuate the area.
-
Alert and Evacuate:
- Notify the Health and Safety Officer, QA, and Warehouse Manager immediately.
- Evacuate all non-essential personnel from the spill area.
- Secure the area to prevent unauthorized access.
5.2 Spill Containment Procedures
-
Use of Personal Protective Equipment (PPE):
- Ensure that all personnel involved in containment wear appropriate PPE (e.g., gloves, goggles, respirators, chemical-resistant suits).
-
Contain the Spill:
- Use absorbent materials, spill containment kits, or dikes to contain the spill and prevent it from spreading.
- For flammable spills, eliminate all ignition sources in the area immediately.
- Document containment actions in the Spill Containment Log (Annexure-1).
5.3 Spill Cleanup Procedures
-
Neutralization (if applicable):
- If the spilled chemical requires neutralization, follow the MSDS instructions carefully.
-
Remove Contaminated Materials:
- Use appropriate tools to collect contaminated materials and dispose of them in designated hazardous waste containers.
- Label waste containers clearly and document in the Hazardous Waste Disposal Log (Annexure-2).
-
Decontaminate the Area:
- Thoroughly clean the affected area with approved cleaning agents and decontamination procedures.
- Ventilate the area if needed, and ensure all residues are removed.
5.4 Post-Spill Actions
-
QA Assessment:
- QA inspects the area to ensure no cross-contamination occurred and assesses whether the spilled materials can be salvaged.
- Document QA findings in the Spill Assessment Report (Annexure-3).
-
Reporting:
- Complete a detailed Spill Incident Report (Annexure-4) describing the cause, containment actions, cleanup, and corrective actions.
- Submit the report to the Health and Safety Manager and QA for review.
-
Supplier Notification (if applicable):
- If the spill resulted from supplier packaging or transportation failure, Procurement must notify the supplier and request corrective actions.
- Document supplier responses in the Corrective Action Log (Annexure-5).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- MSDS: Material Safety Data Sheet
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Spill Containment Log (Annexure-1)
- Hazardous Waste Disposal Log (Annexure-2)
- Spill Assessment Report (Annexure-3)
- Spill Incident Report (Annexure-4)
- Corrective Action Log (Annexure-5)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- OSHA Hazardous Waste Operations and Emergency Response (HAZWOPER)
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Spill Containment Log
| Date | Chemical Name | Batch Number | Type of Spill | Contained By | Remarks |
|---|---|---|---|---|---|
| 01/02/2025 | Acetone | A-2025-001 | Flammable Spill | Ravi Sharma | Contained within 5 minutes |
Annexure-2: Hazardous Waste Disposal Log
| Date | Chemical Name | Batch Number | Disposal Method | Disposed By | Remarks |
|---|---|---|---|---|---|
| 01/02/2025 | Acetone | A-2025-001 | Incineration | Anjali Mehta | Disposed at authorized facility |
Annexure-3: Spill Assessment Report
| Date | Chemical Name | Batch Number | Impact on Material | Reviewed By | Disposition |
|---|---|---|---|---|---|
| 02/02/2025 | Acetone | A-2025-001 | No cross-contamination detected | Deepak Joshi | Rejected |
Annexure-4: Spill Incident Report
| Date | Chemical Name | Batch Number | Description of Incident | Actions Taken | Reported By |
|---|---|---|---|---|---|
| 01/02/2025 | Acetone | A-2025-001 | Container leakage during unloading | Spill contained and area decontaminated | Ravi Sharma |
Annexure-5: Corrective Action Log
| Date | Supplier Name | Chemical Name | Batch Number | Corrective Action Taken | Follow-Up Required |
|---|---|---|---|---|---|
| 03/02/2025 | PharmaChem Ltd. | Acetone | A-2025-001 | Reinforced packaging provided for future shipments | Yes |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Expanded spill containment procedures | Compliance with updated regulations | QA Head |