Elixir Department: SOP for Documentation Control – V 2.0

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Elixir Department: SOP for Documentation Control – V 2.0

Standard Operating Procedure for Documentation Control in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/246/2025
Supersedes SOP/ELX/246/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To establish a systematic approach for the preparation, approval, issuance, revision, retrieval, archival, and destruction of GMP-related documents used in elixir manufacturing to ensure accuracy, consistency, traceability, and regulatory compliance.

2. Scope

This SOP applies to all controlled documents within the Elixir Department, including SOPs, batch manufacturing records (BMR), forms, logs, protocols, reports, and any other GMP-critical documentation.

3. Responsibilities

  • Document Originator:
    • Draft and revise documents as per standard format.
  • QA Documentation Cell:
    • Assign document numbers, control issuance, maintain the document master list, and retrieve obsolete documents.
  • Department Head:
    • Review and approve department-specific documents and ensure implementation.

4. Accountability

The QA Head is accountable for the implementation and compliance of the documentation control procedure across the Elixir Department.

See also  Elixir Department: SOP for Conductivity Monitoring - V 2.0

5. Procedure

5.1 Document Types

  • SOPs (Standard Operating Procedures)
  • Protocols (e.g., validation, qualification)
  • Reports (e.g., validation, deviation, investigation)
  • Records (e.g., BMRs, logbooks,
forms)
  • Master documents (e.g., MFR, MPCR, specifications)

    • 5.2 Document Numbering System

    1. Each document will have a unique identifier (e.g., SOP/ELX/XXX/YYYY) where:
      • XXX = serial number
      • YYYY = year of issue
    2. QA shall maintain a Document Master Index (Annexure-1).

    5.3 Document Preparation

    1. Use standard templates provided by QA.
    2. Include all required sections such as title, purpose, scope, procedure, responsibilities, version, and revision history.
    3. Drafted documents are reviewed by the Department Head and submitted to QA for approval.

    5.4 Document Issuance and Control

    1. QA issues controlled copies with a red “Controlled Copy” stamp and serial number.
    2. Uncontrolled copies (e.g., for training) are marked “Uncontrolled Copy – For Reference Only”.
    3. Obsolete documents are removed from circulation and replaced with updated versions.

    5.5 Document Revision

    1. Revisions are initiated when:
      • Regulatory guidelines change
      • Process/equipment changes
      • Periodic review identifies gaps
    2. Each revision must be reflected in the “Revision History” section.

    5.6 Document Archival and Retention

    1. All obsolete and completed records must be archived in a secure, access-controlled environment.
    2. Retention period:
      • Batch records: 1 year after expiry
      • SOPs and logs: Minimum of 5 years

    5.7 Document Destruction

    1. Expired records are destroyed under QA supervision with documented approval.
    2. Record destruction must be entered in the Document Disposal Register (Annexure-2).

    6. Abbreviations

    • SOP: Standard Operating Procedure
    • QA: Quality Assurance
    • BMR: Batch Manufacturing Record
    • MFR: Master Formula Record

    7. Documents

    1. Document Master Index (Annexure-1)
    2. Document Disposal Register (Annexure-2)
    3. Document Revision Log

    8. References

    • 21 CFR Part 211.180 – General Requirements
    • WHO GMP Guidelines for Pharmaceuticals
    • ICH Q10 – Pharmaceutical Quality System

    9. SOP Version

    Version: 2.0

    10. Approval Section

    Prepared By Checked By Approved By
    Signature
    Date
    Name
    Designation
    Department

    11. Annexures

    Annexure-1: Document Master Index

    Document No. Document Title Version Effective Date Location Status
    SOP/ELX/246/2025 Documentation Control 2.0 15/04/2025 QA Archive Room Active

    Annexure-2: Document Disposal Register

    Date Document No. Title Reason for Disposal Disposed By Approved By
    11/04/2025 SOP/ELX/212/2020 Old Batch Record Procedure Retention Period Over Rajesh Kumar Sunita Reddy

    Revision History:

    Revision Date Revision No. Revision Details Reason for Revision Approved By
    01/01/2024 1.0 Initial SOP Release New SOP Creation QA Head
    11/04/2025 2.0 Added Annexures and clarified retention & disposal Regulatory Update QA Head
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