Standard Operating Procedure for Waste Management and Disposal in GMP Facilities
1) Purpose
This SOP outlines the procedures for the management and disposal of waste generated in GMP-regulated production areas. Proper waste management is critical for preventing contamination and ensuring compliance with environmental regulations.
2) Scope
This SOP applies to all personnel involved in waste handling and disposal at [Company Name].
3) Responsibilities
- Operators: Ensure proper segregation of waste and disposal in designated areas.
- Supervisors: Monitor waste disposal activities and ensure compliance with waste management procedures.
- Environmental, Health, and Safety (EHS) Team: Ensure compliance with local regulations for waste disposal and manage waste disposal contractors.
4) Procedure
4.1 Waste Segregation
4.1.1 Waste Categories
- Waste generated in GMP areas must be segregated into the following categories:
- Hazardous waste
- Non-hazardous waste
- Biological waste
- Recyclable waste
4.1.2 Proper Labeling
- Label all waste containers clearly, specifying the type of waste and any relevant handling instructions. Ensure labels are visible and legible at all times.
- For hazardous waste, include hazard symbols and any necessary precautions on the labels.
4.2 Waste Disposal Procedures
4.2.1 Hazardous Waste Disposal
- Dispose of hazardous waste following the guidelines provided
in the Safety Data Sheet (SDS) for each chemical. Coordinate with certified waste disposal contractors for hazardous waste removal.
Document all hazardous waste disposals in the waste management log, including the type of waste, quantity, and disposal method.
4.2.2 Non-Hazardous Waste Disposal
- Dispose of non-hazardous waste in designated containers and ensure it is removed regularly. Non-hazardous waste may include packaging materials, paper, and general waste from GMP areas.
4.2.3 Biological Waste Disposal
- Dispose of biological waste following regulatory guidelines. This includes biological samples, used gloves, or any contaminated equipment. Use biohazard bags and ensure that waste is autoclaved before disposal.
4.3 Post-Operation Activities
4.3.1 Waste Management Documentation
- Record all waste disposal activities, including the type of waste, quantity, and disposal method, in the waste management log. Ensure all entries are reviewed by the EHS team and QA.
4.3.2 Compliance Monitoring
- The EHS team will perform regular audits to ensure compliance with waste management regulations. Any deviations from the SOP must be documented in the deviation log and corrective actions implemented.
5) Abbreviations, if any
- GMP: Good Manufacturing Practices
- EHS: Environmental, Health, and Safety
6) Documents, if any
- Waste Management Log
- Deviation Log
7) References, if any
- Local environmental regulations
- Internal SOP for hazardous waste disposal
8) SOP Version
Version 1.0
Annexure
1. Waste Management Log Template
| Date | Waste Type | Quantity (kg/L) | Disposal Method | Operator Initials | Supervisor Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | Type of Waste | Quantity Disposed | Disposal Method | Operator Name | Supervisor Name |