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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 Handling and Disposal of Expired Pharmaceuticals

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
  2. less
    Copy code

  3. 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.
  4. 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
  5. 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
  6. 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.
See also  SOP for Preparing and Maintaining EHS Policies

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
Environment, Health and Safety Tags:Emergency response for hazardous materials incidents, Hazardous materials classification, Hazardous materials compliance audits, Hazardous materials decontamination procedures, Hazardous materials disposal methods, Hazardous materials emergency planning, Hazardous materials emergency response guidebook, Hazardous materials exposure limits, Hazardous materials handling, Hazardous materials handling equipment, Hazardous materials incident command system, Hazardous materials incident reporting, Hazardous materials inventory management, Hazardous materials labeling requirements, Hazardous materials monitoring equipment, Hazardous materials packaging requirements, Hazardous materials placarding requirements, Hazardous materials regulatory agencies, Hazardous materials response team training, Hazardous materials risk assessment, Hazardous materials security plans, Hazardous materials shipping papers, Hazardous materials spill response, Hazardous materials storage guidelines, Hazardous materials training requirements, Hazardous materials transportation regulations, Hazardous materials transportation safety, Personal protective equipment for hazardous materials, Regulatory compliance in hazardous materials management, Safety procedures for hazardous materials

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Standard Operating Procedures V 1.0

  • Aerosols
  • Analytical Method Development
  • Bioequivalence Bioavailability Study
  • Capsule Formulation
  • Clinical Studies
  • Creams
  • Data Integrity
  • Dental Dosage Forms
  • Drug Discovery
  • Environment, Health and Safety
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  • Good Distribution Practice
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  • Lotions
  • Lyophilized Products
  • Maintenance Dept.
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  • Microbiology Testing
  • Nanoparticle Formulation
  • Nasal Spray Formulations
  • Nebulizers
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  • Pharmacovigilance
  • Powder & Granules
  • Purchase Departments
  • Quality Assurance
  • Quality Control
  • Raw Material Stores
  • Regulatory Affairs
  • Tablet Manufacturing
  • Rectal Dosage Forms
  • Transdermal Patches
  • Vaginal Dosage Forms
  • Validations and Qualifications

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NEW! Revised SOPs – V 2.0

  • Aerosols V 2.0
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
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  • Ointments V 2.0
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