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SOP for Equipment Decommissioning and Disposal

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SOP for Equipment Decommissioning and Disposal

Standard Operating Procedure for Equipment Decommissioning and Disposal

1) Purpose

The purpose of this SOP is to establish guidelines for the proper decommissioning and disposal of equipment in pharmaceutical manufacturing facilities to ensure compliance with environmental regulations and safety standards.

2) Scope

This SOP applies to all equipment that is no longer in use and requires decommissioning and disposal within the facility premises.

3) Responsibilities

The Facilities Management Department is responsible for implementing and adhering to this SOP. The Equipment Manager or designated personnel are responsible for overseeing the decommissioning and disposal process.

See also  SOP for Preventive Maintenance Program

4) Procedure

  1. Inventory and Assessment
    1. Compile an inventory of equipment slated for decommissioning.
    2. Assess each piece of equipment for potential reuse, recycling, or disposal.
  2. Decommissioning Process
    1. Disconnect equipment from utilities and remove any hazardous materials, such as chemicals or radioactive sources, following safety protocols.
    2. Ensure proper labeling and tagging of decommissioned equipment.
  3. Disposal Methods
    1. Select appropriate disposal methods based on equipment type and condition, such as recycling through certified vendors or disposal in accordance with local regulations.
    2. Dispose of hazardous materials in compliance with hazardous waste disposal regulations.
  4. Documentation and Reporting
    1. Maintain detailed records of equipment decommissioning activities, including inventory lists, disposal receipts, and hazardous waste manifests.
    2. Document any environmental assessments or approvals required for disposal activities.
See also  SOP for Continuous Improvement in Maintenance Activities

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Equipment Inventory List, Disposal Records, Hazardous Waste Manifests, Environmental Assessment Reports

7) Reference, if any

EPA regulations for hazardous waste disposal, local recycling guidelines, manufacturer’s recommendations for equipment disposal, and internal environmental policies.

8) SOP Version

Version 1.0

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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
  • Formulation Development
  • Gels
  • Good Distribution Practice
  • Good Warehousing Practices
  • In-Process Control
  • Injectables
  • Liquid Orals
  • Liposome and Emulsion Formulations
  • Lotions
  • Lyophilized Products
  • Maintenance Dept.
  • Medical Devices
  • Metered-Dose Inhaler
  • Microbiology Testing
  • Nanoparticle Formulation
  • Nasal Spray Formulations
  • Nebulizers
  • Ocular (Eye) Dosage Forms
  • Ointments
  • Otic (Ear) Dosage Forms
  • 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
  • Capsules V 2.0
  • Creams V 2.0
  • Elixers V 2.0
  • Ointments V 2.0
  • Raw Material Warehouse V 2.0
  • Tablet Manufacturing V2.0

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