Skip to content
  • Clinical Studies
  • Pharma GMP
  • Pharma Tips
  • Stability Studies
  • Pharma Books
  • Schedule M

SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

  • Home
  • Job Safety Analysis (JSA)
    • Oral Dosage Forms (Tablets & Capsules)
    • Oral Liquid Dosage Forms (Syrups, Elixirs, Suspensions, Emulsions)
    • Powder and Granule Dosage Forms
    • Topical Dosage Forms (Creams, Ointments, Gels, Lotions, Pastes)
    • Transdermal Dosage Forms (Patches)
  • Standard Test Procedures (STP)
  • SOP – Blog Post
  • Toggle search form

SOP for Archiving Expired or Obsolete Safety Documents

Posted on By

SOP for Archiving Expired or Obsolete Safety Documents

Standard Operating Procedure for Archiving Expired or Obsolete Safety Documents

1) Purpose

The purpose of this SOP is to establish a standardized process for archiving expired or obsolete safety documents to ensure proper record management, compliance with regulatory standards, and ease of retrieval when needed.

2) Scope

This SOP applies to all expired or obsolete safety-related documents, including policies, procedures, training materials, inspection records, and regulatory compliance documentation maintained by the organization.

3) Responsibilities

  • Document Control Manager: Oversee the archiving process and ensure compliance with retention policies.
  • Records Manager: Organize and secure archived documents in both physical and digital repositories.
  • Department Heads: Identify documents within their departments that need archiving and approve their transfer to the archive.
  • Compliance Officer: Ensure archived documents are retained for the appropriate duration as per regulatory requirements.
See also  SOP for Emergency Decontamination Procedures

4) Procedure

4.1 Identifying Documents for Archiving

  1. Review Retention Schedules:
    • Refer to the organization’s document retention policy to identify documents eligible for archiving.
  2. less
    Copy code

  3. Classify Documents:
    • Classify documents as “expired” if they are no longer valid or as “obsolete” if they have been replaced by updated versions.
  4. Notify Relevant Departments:
    • Inform department heads about documents identified for archiving and obtain their approval.

4.2 Preparing Documents for Archiving

  1. Label Documents:
    • Label each document with its category, expiration or obsolescence
date, and a unique identifier for tracking.

less
Copy code

  • Create an Archive Inventory:
    • List documents to be archived in the Archive Inventory Log (Annexure 1), including details such as document title, category, and retention period.
  • Organize by Category:
    • Group documents by type, such as training records, inspection reports, or regulatory submissions, for efficient storage and retrieval.
  • 4.3 Archiving Documents

    1. Digital Archiving:
      • Scan physical documents, if applicable, and store digital copies in a secure document management system with restricted access.
    2. less
      Copy code

    3. Physical Archiving:
      • Store physical documents in labeled folders or boxes in a designated archive room, ensuring protection from environmental damage.
    4. Secure Access:
      • Restrict access to archived documents to authorized personnel and maintain an access log.

    4.4 Maintaining Archived Documents

    1. Conduct Regular Audits:
      • Audit the archive annually to ensure documents are stored properly and remain accessible when needed.
    2. less
      Copy code

    3. Track Retention Periods:
      • Monitor retention periods and schedule the destruction of documents that are no longer required to be kept.
    4. Document Changes:
      • Update the Archive Inventory Log to reflect any changes, such as additions or destruction of records.

    4.5 Destruction of Expired Records

    1. Follow Destruction Policies:
      • Dispose of expired records securely as per the organization’s destruction policy, such as shredding physical copies or securely deleting digital files.
    2. less
      Copy code

    3. Document Destruction:
      • Record the destruction of documents in the Document Destruction Log (Annexure 2) for audit purposes.

    5) Abbreviations, if any

    • EHS: Environmental, Health, and Safety

    6) Documents, if any

    • Archive Inventory Log
    • Document Destruction Log
    • Retention Policy Document

    7) Reference, if any

    • ISO 15489-1 Records Management Standards
    • Local Regulations for Document Retention and Disposal

    8) SOP Version

    Version: 1.0

    Annexure

    Template 1: Archive Inventory Log

     
    Document ID Document Title Category Retention Period Archival Date
    DOC-001 Fire Safety Inspection Report Inspection Records 5 Years DD/MM/YYYY

    Template 2: Document Destruction Log

     
    Document ID Document Title Destruction Date Method Approved By
    DOC-002 Expired Hazardous Waste Permit DD/MM/YYYY Shredding John Doe
    See also  SOP for Sampling Hazardous Materials Safely
    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

    Post navigation

    Previous Post: SOP for Preclinical Study Data Review Meetings
    Next Post: SOP for Preparing and Maintaining Audit Trail for EHS Activities

    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

    Read SOPs in your Language:

     - 
    Bengali
     - 
    bn
    English
     - 
    en
    Gujarati
     - 
    gu
    Hindi
     - 
    hi
    Malayalam
     - 
    ml
    Marathi
     - 
    mr
    Punjabi
     - 
    pa
    Tamil
     - 
    ta
    Telugu
     - 
    te

    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

    New Publication: A must for All.

    Copyright © 2025 SOP Guide for Pharma.

    Powered by PressBook WordPress theme

    Go to mobile version