Standard Operating Procedure for Handling and Disposal of Waste in Transdermal Patches Production

1) Purpose

The purpose of this SOP is to establish guidelines for the proper handling, segregation, storage, and disposal of waste generated during the production of transdermal patches to ensure environmental protection and regulatory compliance.

2) Scope

This SOP applies to all waste generated in the manufacturing process of transdermal patches, including raw material waste, packaging waste, and process waste.

3) Responsibilities

The Production Manager is responsible for overseeing the implementation of waste handling and disposal procedures. All personnel involved in waste management must adhere to this SOP.

4) Procedure

4.1 Waste Segregation and Collection

• 4.1.1 Segregate different types of waste (e.g., chemical, biological, general) at the point of generation using designated containers.
• 4.1.2 Label each waste container with the type of waste, date, and area of origin.
• 4.1.3 Use color-coded bins or labels to distinguish between different types of waste as per regulatory requirements.

4.2 Storage of Waste

• 4.2.1 Store waste containers securely in designated storage areas that are inaccessible to unauthorized personnel.
• 4.2.2 Ensure that storage areas are well-ventilated, fire-safe, and equipped with spill containment measures.
• 4.2.3 Monitor and maintain waste storage areas to prevent leaks, spills, or environmental contamination.

4.3 Waste Disposal

• 4.3.1 Dispose of hazardous waste (e.g., solvents, chemicals) according to local regulatory requirements and guidelines.
• 4.3.2 Contract with authorized waste disposal vendors for proper collection, transportation, and disposal of hazardous and non-hazardous waste.
• 4.3.3 Complete waste disposal manifests and other required documentation for tracking and regulatory compliance.

4.4 Spill Response

• 4.4.1 Develop and maintain a spill response procedure for accidental spills of hazardous materials.
• 4.4.2 Train personnel on spill response protocols, including containment, cleanup, and reporting procedures.
• 4.4.3 Document all spill incidents, including root cause analysis and corrective actions taken.

4.5 Training and Awareness

• 4.5.1 Provide training to personnel involved in waste handling and disposal on the proper segregation, storage, and disposal practices.
• 4.5.2 Conduct periodic refresher training sessions and maintain records of training attendance.

4.6 Compliance and Documentation

• 4.6.1 Maintain records of waste generation, handling, and disposal activities, including waste manifests, disposal certificates, and training records.
• 4.6.2 Conduct regular audits and inspections to ensure compliance with SOPs and regulatory requirements.
• 4.6.3 Review and update the SOP as necessary based on changes in waste management practices or regulatory requirements.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Waste Manifests
Training Records

7) Reference, if any

EPA Guidelines for Hazardous Waste Management
WHO Guidelines on Health-Care Waste Management

8) SOP Version

Version 1.0