SOP Guide for Pharma

SOP for Documentation of Waste Management Activities

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SOP for Documentation of Waste Management Activities

Standard Operating Procedure for Documentation of Waste Management Activities

1) Purpose

The purpose of this SOP is to establish a standardized process for documenting all waste management activities, ensuring accurate record-keeping, regulatory compliance, and traceability of waste generation, storage, transportation, and disposal.

2) Scope

This SOP applies to all personnel responsible for recording, reviewing, and managing waste-related activities in manufacturing units, laboratories, warehouses, and administrative offices.

3) Responsibilities

  • Supervisors: Ensure waste documentation is completed accurately and submitted for review.
  • Waste Management Personnel: Record waste-related data, update logs, and coordinate with vendors.
  • Safety Officers: Review documentation for accuracy and compliance with regulatory standards.
  • Auditors: Verify records during internal and external waste management audits.

4) Procedure

4.1 Categories of Waste Documentation

The following documents must be maintained for proper waste management activities:

  1. Waste Generation Records: Logs recording the type, quantity, and source of waste.
  2. Waste Storage Records: Logs documenting storage conditions, location, and duration.
  3. Waste Transport Records: Transport manifests for internal and external movement of waste.
  4. Waste Disposal Records: Certificates and manifests confirming final disposal by authorized vendors.
  5. Incident Reports: Records of spills, leaks, or any incidents during waste management activities.
See also  SOP for Responding to Hazardous Material Exposure Incidents

4.2 Waste Documentation Process

  1. Recording Waste Generation:
    • Identify the type of waste generated (hazardous, biomedical, chemical, general, e-waste).
    • Record waste data in the Waste
Generation Log (Annexure 1) with the following details:
  • Source (e.g., department, production line)
  • Type of waste
  • Quantity (Kg or Liters)
  • Date of generation
  • Handled by

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  • Documenting Waste Storage:
    • Record the storage location, duration, and safety precautions taken.
    • Ensure each container is labeled with waste type, hazard symbol, and generation date.
    • Update the Waste Storage Log (Annexure 2) weekly to prevent overstocking.
  • Internal Waste Transport Documentation:
    • Document waste movement from generation areas to storage or treatment zones.
    • Use the Internal Waste Transport Log (Annexure 3) to include:
      • Waste type and quantity
      • Source and destination
      • Date and time of transport
      • Handled by
  • External Waste Transport and Disposal Documentation:
    • Ensure waste is transported using authorized vendors and compliant vehicles.
    • Retain all transport manifests and disposal certificates provided by vendors.
    • Update the Waste Disposal Log (Annexure 4) with:
      • Waste type and quantity
      • Disposal method
      • Vendor details
      • Certificate number
  • Incident Documentation:
    • In the event of a spill, leak, or mishandling, complete the Incident Report Form (Annexure 5).
    • Document details of the incident, including root cause, corrective actions, and personnel involved.

    • 4.3 Review and Submission of Waste Documentation

    1. Daily Review: Supervisors must verify the accuracy of logs maintained by waste handlers.
    2. Weekly Updates: Waste management personnel must compile all logs and submit them to Safety Officers for review.
    3. Monthly Reporting: Summarize waste management activities, including:
      • Waste generation trends
      • Disposal records
      • Incidents reported

      Submit monthly reports to management for review and compliance monitoring.

    4.4 Record Retention

    1. Maintain all waste-related records for a minimum of 5 years for compliance audits.
    2. Store physical records in secure filing cabinets and ensure digital records are backed up on a centralized system.

    5) Abbreviations, if any

    • PPE: Personal Protective Equipment
    • EPA: Environmental Protection Agency

    6) Documents, if any

    • Waste Generation Log
    • Waste Storage Log
    • Internal Waste Transport Log
    • Waste Disposal Log
    • Incident Report Form

    7) Reference, if any

    • Hazardous Waste Management Rules, 2016
    • EPA Resource Conservation and Recovery Act (RCRA)
    • OSHA Hazard Communication Standard

    8) SOP Version

    Version: 1.0

    Annexure

    Template 1: Waste Generation Log
    Date Department Waste Type Quantity Handled By
    DD/MM/YYYY Production Chemical Waste 20 Kg John Doe

    Template 2: Waste Storage Log
    Date Waste Type Storage Location Duration Inspected By
    DD/MM/YYYY Expired Chemicals Hazardous Room 3 7 Days Jane Smith

    Template 3: Waste Disposal Log
    Date Waste Type Quantity Disposal Method Vendor Name Certificate No.
    DD/MM/YYYY Biohazard Waste 15 Kg Incineration XYZ Disposal CERT-12345

    Template 4: Incident Report Form
    Date Incident Type Location Description Corrective Action Reported By
    DD/MM/YYYY Spill Storage Area 2 5 Liters of solvent spilled Contained and cleaned up John Doe
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