SOP Guide for Pharma

SOP for Archiving Expired or Obsolete Safety Documents

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.

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.
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  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    • Classify documents as “expired” if they are no longer valid or as “obsolete” if they have been replaced by updated versions.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.

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  • 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.
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    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.
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    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.
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    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
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