Standard Operating Procedure for Waste Disposal System in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish procedures for the proper disposal of waste generated during the manufacturing of ocular dosage forms to ensure compliance with environmental regulations and maintain a clean and safe manufacturing environment.

2) Scope

This SOP applies to all waste disposal activities within the facility related to the manufacturing of ocular dosage forms, including the disposal of chemical, biological, and general waste.

3) Responsibilities

Facility management and designated waste management personnel are responsible for the implementation and enforcement of waste disposal procedures. All employees involved in the manufacturing process are responsible for adhering to waste disposal guidelines.

4) Procedure

4.1 Waste Segregation

1. Segregate waste at the point of generation into categories such as chemical waste, biological waste, and general waste.
2. Use color-coded bins or labeled containers to facilitate proper waste segregation.

4.2 Waste Collection

1. Collect waste regularly from designated bins and containers to prevent overflow and contamination.
2. Wear appropriate personal protective equipment (PPE) when handling waste.

4.3 Chemical Waste Disposal

1. Store chemical waste in labeled, leak-proof containers until disposal.
2. Dispose of chemical waste according to local environmental regulations and facility guidelines.
3. Maintain records of chemical waste disposal, including the type and quantity of waste and the disposal method.

4.4 Biological Waste Disposal

1. Decontaminate biological waste using autoclaving or other approved methods before disposal.
2. Dispose of decontaminated biological waste in designated biohazard waste containers.
3. Follow local regulations and facility guidelines for the disposal of biological waste.

4.5 General Waste Disposal

1. Dispose of non-hazardous general waste in standard waste bins.
2. Ensure general waste is regularly collected and disposed of by authorized waste management services.

4.6 Hazardous Waste Disposal

1. Identify and label hazardous waste appropriately.
2. Store hazardous waste in designated secure areas until disposal.
3. Dispose of hazardous waste through licensed hazardous waste disposal services.

4.7 Emergency Procedures

1. Develop and maintain emergency procedures for waste spills, leaks, or other incidents.
2. Train personnel on emergency response procedures and ensure the availability of spill containment kits and other necessary equipment.

4.8 Documentation and Records

1. Maintain records of waste generation, collection, and disposal activities.
2. Document any deviations from standard procedures and corrective actions taken.

4.9 Training

1. Provide training to all personnel involved in waste handling and disposal activities.
2. Ensure personnel are aware of SOP updates and revisions related to waste disposal procedures.

5) Abbreviations, if any

SOP: Standard Operating Procedure

PPE: Personal Protective Equipment

6) Documents, if any

1. Waste disposal log
2. Hazardous waste disposal records
3. Emergency response plan

7) Reference, if any

Environmental Protection Agency (EPA) Guidelines

Local Environmental Regulations

8) SOP Version

Version 1.0