Standard Operating Procedure for Waste Management and Disposal

1) Purpose

The purpose of this SOP is to establish guidelines for the proper management and disposal of waste generated in pharmaceutical manufacturing facilities to ensure environmental protection and regulatory compliance.

2) Scope

This SOP applies to all waste generated within pharmaceutical manufacturing facilities, including hazardous, non-hazardous, and pharmaceutical waste.

3) Responsibilities

The Facility Management Department is responsible for implementing and adhering to this SOP. The Waste Management Coordinator oversees waste management and disposal activities.

4) Procedure

1. Waste Segregation
   1. Segregate waste at the point of generation into categories such as hazardous, non-hazardous, recyclable, and pharmaceutical waste.
   2. Use appropriate containers and labeling to ensure proper identification and segregation of waste streams.
2. Storage and Handling
   1. Store waste in designated areas with adequate containment and secondary containment measures.
   2. Ensure compatibility of waste types and containers to prevent leaks or spills.
3. Disposal Methods
   1. Select approved waste disposal methods based on waste type and regulatory requirements, such as incineration, landfill disposal, or recycling.
   2. Contract with licensed waste disposal companies and ensure compliance with local, state, and federal regulations.
4. Documentation and Record Keeping
   1. Maintain accurate records of waste generation, storage, and disposal activities.
   2. Document waste characterization, disposal certificates, and regulatory compliance documentation.
5. Training and Awareness
   1. Provide training to personnel on proper waste management practices, including segregation, handling, and emergency response.
   2. Promote awareness of waste reduction and recycling initiatives among staff.

5) Abbreviations, if any

None

6) Documents, if any

Waste Management Plan, Waste Disposal Records, Disposal Certificates, Training Records

7) Reference, if any

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

8) SOP Version

Version 1.0