Standard Operating Procedure for Handling and Disposal of Waste Materials

1) Purpose

The purpose of this SOP is to establish procedures for the safe handling, segregation, and disposal of waste materials generated during the manufacturing of dental dosage forms to ensure compliance with environmental regulations and minimize environmental impact.

2) Scope

This SOP applies to all waste materials generated in the production of dental pastes, gels, and mouthwashes within the pharmaceutical industry.

3) Responsibilities

The Production Department is responsible for implementing waste handling procedures. The Environmental Health and Safety (EHS) Department is responsible for verifying compliance with environmental regulations.

4) Procedure

4.1 Waste Segregation

4.1.1 Segregate waste materials at the point of generation into appropriate categories (e.g., general waste, hazardous waste, recyclable waste).

4.1.2 Use designated containers and labels for each waste category to prevent mixing and ensure proper identification.

4.2 Storage and Accumulation

4.2.1 Store waste materials in designated areas with adequate labeling and signage.

4.2.2 Maintain storage containers in good condition and ensure they are leak-proof and secure.

4.3 Handling and Transport

4.3.1 Handle waste materials with appropriate personal protective equipment (PPE) and follow safe handling practices.

4.3.2 Transport waste containers safely to designated waste collection points or storage areas.

4.4 Disposal

4.4.1 Dispose of waste materials through approved waste management vendors or facilities in compliance with local regulations.

4.4.2 Complete waste disposal manifests or documentation as required by regulatory authorities.

4.5 Emergency Response

4.5.1 Respond promptly to spills, leaks, or other emergencies involving waste materials.

4.5.2 Implement emergency procedures and containment measures to minimize environmental impact.

4.6 Documentation

4.6.1 Maintain records of waste handling activities, including waste generation, segregation, storage, transport, and disposal.

4.6.2 Retain disposal receipts, manifests, and certificates of disposal for audit and regulatory purposes.

5) Abbreviations, if any

SOP – Standard Operating Procedure

EHS – Environmental Health and Safety

6) Documents, if any

Waste Management Plan

Waste Disposal Records

Emergency Response Procedures

7) Reference, if any

Environmental Protection Agency (EPA) regulations

Local waste management regulations

8) SOP Version

Version 1.0