1) SOP for Waste Management

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the proper disposal of waste materials generated during the manufacturing process, including hazardous waste, in compliance with regulatory requirements and environmental standards.

3) Scope

This SOP applies to all waste materials generated within the pharmaceutical manufacturing facility, including non-hazardous waste, hazardous waste, and recyclable materials.

4) Responsibilities

• Environmental Health and Safety (EHS) Department: Responsible for developing and implementing waste management procedures and ensuring compliance with regulations.
• All Employees: Responsible for following waste management procedures and properly disposing of waste materials.
• Supervisors: Responsible for ensuring their team members are trained on waste management procedures.
• Waste Management Contractor: Responsible for the collection, transportation, and disposal of waste materials as per contractual agreements and regulations.

5) Procedure

1. Classification of Waste
   1. Identify and classify waste materials into categories such as non-hazardous waste, hazardous waste, and recyclable materials.
   2. Label waste containers clearly with the appropriate waste classification.
2. Waste Segregation
   1. Segregate waste materials at the point of generation to prevent cross-contamination.
   2. Use designated waste containers for different types of waste (e.g., general waste, hazardous waste, recyclable materials).
   3. Ensure that waste containers are properly labeled and color-coded according to the type of waste.
3. Waste Collection and Storage
   1. Collect waste materials regularly and transport them to designated storage areas.
   2. Ensure that waste storage areas are secure, well-ventilated, and compliant with regulatory requirements.
   3. Store hazardous waste in appropriate containers that are compatible with the waste material and resistant to leaks and spills.
4. Waste Disposal
   1. Non-Hazardous Waste
      1. Dispose of non-hazardous waste through the municipal waste management system or authorized waste disposal contractor.
   2. Hazardous Waste
      1. Dispose of hazardous waste through a licensed hazardous waste management contractor.
      2. Ensure that hazardous waste is transported and disposed of in compliance with regulatory requirements and safety standards.
   3. Recyclable Materials
      1. Collect recyclable materials separately and transport them to designated recycling facilities.
      2. Ensure that recyclable materials are clean and free from contaminants.
5. Documentation and Record Keeping
   1. Maintain accurate records of waste generation, classification, collection, storage, and disposal.
   2. Document the quantities and types of waste materials disposed of and the methods used for disposal.
   3. Retain waste management records for the required period as per regulatory and company policies.
6. Training and Awareness
   1. Provide training to employees on waste management procedures and regulatory requirements.
   2. Conduct regular refresher training sessions and awareness programs to ensure ongoing compliance.
7. Continuous Improvement
   1. Regularly review and update waste management procedures to ensure compliance with changing regulations and industry best practices.
   2. Encourage employees to provide feedback on waste management practices and suggest areas for improvement.
   3. Implement corrective actions based on audit findings, incidents, or deviations related to waste management.

6) Abbreviations, if any

• EHS: Environmental Health and Safety
• SOP: Standard Operating Procedure

7) Documents, if any

• Waste Classification and Segregation Guidelines
• Waste Collection and Disposal Records
• Training Records

8) Reference, if any

• Resource Conservation and Recovery Act (RCRA)
• Environmental Protection Agency (EPA) Guidelines
• Company-specific waste management policies

9) SOP Version

Version 1.0