Procedure for Handling Hazardous Materials During Dispensing
| Department | Production/Quality Assurance/Safety |
|---|---|
| SOP No. | SOP/Ointment/009 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a safe and standardized process for handling hazardous raw materials during dispensing in ointment manufacturing. This ensures the safety of personnel, prevents contamination, and maintains compliance with Good Manufacturing Practices (GMP) and occupational health standards.
2. Scope
This SOP applies to all personnel involved in the handling, weighing, and dispensing of hazardous materials, including active pharmaceutical ingredients (APIs) and excipients classified as hazardous. It covers material handling, personal protective equipment (PPE) requirements, emergency procedures, and documentation.
3. Responsibilities
- Production Operator: Ensures safe handling, dispensing, and labeling of hazardous materials.
- Quality Control (QC) Personnel: Verifies compliance with material handling guidelines.
- Production Supervisor: Monitors dispensing activities to prevent exposure and contamination.
- Quality Assurance (QA) Officer: Ensures compliance with safety and GMP regulations.
- Safety Officer: Provides training on hazardous material handling and ensures emergency preparedness.
4. Accountability
The Production Manager and Safety Officer are accountable for ensuring that hazardous materials are handled and dispensed safely, and that records are maintained properly.
5. Procedure
5.1 Identification of Hazardous Materials
- Refer to the Material Safety
Data Sheet (MSDS) for each hazardous material.
Ensure that hazardous materials are labeled with proper warning signs.
Maintain an updated inventory of all hazardous raw materials used in dispensing.
5.2 Personal Protective Equipment (PPE) Requirements
- Wear the following PPE before handling hazardous materials:
- Disposable gloves (Nitrile or Latex-resistant)
- Full-body protective gown
- Safety goggles or face shield
- Respiratory mask (if material has airborne exposure risk)
- Shoe covers
- Ensure PPE is changed after each dispensing session or if visibly contaminated.
5.3 Handling and Dispensing Process
- Ensure the dispensing booth is operational with proper airflow and exhaust.
- Dispense hazardous materials inside a dedicated containment area with local exhaust ventilation.
- Weigh and transfer hazardous materials using dedicated, non-reactive containers.
- Minimize direct contact and avoid spills by using precision dispensing tools.
- Ensure all dispensed materials are immediately labeled with appropriate hazard warnings.
5.4 Emergency Procedures for Spills and Exposure
- In case of a spill:
- Alert nearby personnel and restrict access to the contaminated area.
- Use spill control absorbents to contain and neutralize hazardous materials.
- Dispose of spill residues in designated hazardous waste containers.
- Record the incident in the Hazardous Material Incident Log.
- In case of skin contact:
- Rinse the affected area with water for at least 15 minutes.
- Seek medical attention if irritation persists.
- Document the incident in the Safety Incident Report.
- In case of inhalation exposure:
- Move to fresh air immediately.
- Administer oxygen if necessary and seek medical attention.
- Document the incident and review PPE effectiveness.
5.5 Storage of Hazardous Materials
- Store hazardous materials in dedicated safety cabinets with proper ventilation.
- Ensure materials are segregated based on compatibility to prevent reactions.
- Label storage areas with appropriate hazard signs and warnings.
5.6 Disposal of Hazardous Waste
- Collect hazardous material waste in designated, labeled disposal containers.
- Follow regulatory guidelines for hazardous waste disposal.
- Maintain records of disposed materials in the Hazardous Waste Disposal Log.
5.7 Documentation and Record-Keeping
- Maintain records of hazardous material handling, spills, and waste disposal.
- Ensure all entries are reviewed and approved by the QA and Safety Officer.
- Conduct regular safety audits and update SOPs accordingly.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- MSDS – Material Safety Data Sheet
- PPE – Personal Protective Equipment
7. Documents
- Hazardous Material Incident Log (Annexure-1)
- Hazardous Waste Disposal Log (Annexure-2)
8. References
- OSHA Hazard Communication Standard (29 CFR 1910.1200)
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
- ICH Q7: Good Manufacturing Practice Guide
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Hazardous Material Incident Log
| Date | Material Name | Incident Type | Corrective Action | Reviewed By |
|---|---|---|---|---|
| 01/02/2025 | Material A | Spillage | Neutralized with absorbent | Safety Officer |
| 02/02/2025 | Material B | Inhalation Exposure | Medical Assistance Provided | QA Head |
Annexure-2: Hazardous Waste Disposal Log
| Date | Material Name | Quantity | Disposal Method | Disposed By |
|---|---|---|---|---|
| 01/02/2025 | Material A | 5 kg | Incineration | John Doe |
| 02/02/2025 | Material B | 3 kg | Hazardous Waste Facility | Jane Smith |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Approved By |
|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | QA Head |