Standard Operating Procedure for Environmental Compliance in Maintenance

1) Purpose

The purpose of this SOP is to establish guidelines for maintaining environmental compliance during maintenance activities to prevent pollution and ensure regulatory adherence in pharmaceutical manufacturing facilities.

2) Scope

This SOP applies to all maintenance activities conducted within pharmaceutical manufacturing facilities, including equipment, utilities, facilities, and safety systems, with potential environmental impact.

3) Responsibilities

The Facility Management Department is responsible for implementing and adhering to this SOP. The Environmental Health and Safety (EHS) Officer collaborates with the Maintenance Supervisor to ensure environmental compliance in maintenance activities.

4) Procedure

1. Environmental Risk Assessment
   1. Conduct environmental risk assessments before initiating maintenance tasks.
   2. Identify potential environmental hazards, such as chemical spills or emissions.
   3. Implement controls and mitigation measures to prevent environmental impacts.
2. Waste Management
   1. Segregate and dispose of waste generated during maintenance activities according to regulatory requirements.
   2. Label hazardous waste containers and store them in designated areas.
3. Spill Response and Containment
   1. Develop spill response procedures and maintain spill kits for immediate containment and cleanup of hazardous materials.
   2. Train personnel on spill response protocols and reporting requirements.
4. Compliance Monitoring
   1. Monitor compliance with environmental regulations and permit requirements during maintenance activities.
   2. Conduct regular inspections and audits to verify adherence to environmental standards.
5. Documentation and Reporting
   1. Maintain records of environmental permits, inspections, and compliance assessments.
   2. Generate reports on environmental performance and incidents, including corrective actions taken.

5) Abbreviations, if any

EHS: Environmental Health and Safety

6) Documents, if any

Environmental Risk Assessment Reports, Waste Disposal Records, Spill Response Plans, Compliance Audit Reports

7) Reference, if any

Environmental regulations such as EPA regulations, and relevant regulatory requirements for environmental compliance in pharmaceutical manufacturing facilities.

8) SOP Version

Version 1.0