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    QMS 010 Classification Definition and Approval Matrix of GMP Documents Sample

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    Rosella Planta

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    QMS 010 Classification Definition and Approval Matrix of GMP Documents Sample

    Uploaded by

    Rosella Planta
    200 views5 pages

    Original Title

    QMS-010-Classification-Definition-and-Approval-Matrix-of-GMP-Documents-sample

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    Copyright:

    © All Rights Reserved
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    Download as pdf or txt
    200 views5 pages

    QMS 010 Classification Definition and Approval Matrix of GMP Documents Sample

    Uploaded by

    Rosella Planta

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 5

    Standard Operating Procedure

    Title: Classification, Definition and Approval Matrix of GMP Documents

    Quality Documents Prefix ID


    1. SOP Area specific e.g QMS
    2. Forms Form
    3. Policies POL
    4. Visual Display VD
    5. Audit Reports AUD
    6. Quality Manual MAN
    7. Training TRN
    8. QA (GMP) Agreements GMP
    9. Investigation/Incident Meeting Minutes INV/INI
    10. Position Paper POS
    11. Quality Template TEM
    12. Vendor Audit Report AUD-vendor no
    13. TPM (Third Party Manufacture) Dispatch Report TPM
    14. Technical Files TF
    15. Project File PF
    16. Maintenance and Operation Manual MAN
    17. Procedural Manual MAN
    18. Presentation PPT
    19. Regulatory Standards STD
    20. Compendia -

    Master File Documents Prefix ID

    1. Control Method CM
    2. Specification (Raw Material/Finished Product/Packaging) SPC
    3. Formulation FLN
    4. Packaging Material Specifications and Test Report PMS
    5. Manufacturing Formula MF
    6. Manufacturing Instruction MI
    7. Bill of Materials BOM
    8. Stability Specification SS
    9. Finished Goods Specification and Test Report FGS
    10. Raw Material Specification and Test Report RMS

    2. Definition of all types of Quality Documents

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    Unauthorized copying, publishing, transmission and distribution of any part of the content by
    electronic means are strictly prohibited. Page 2 of 11
    Standard Operating Procedure
    Title: Classification, Definition and Approval Matrix of GMP Documents

    Packaging
    Developm Procurement Technical Service
    Packaging Specifications N/A
    ent Manager

    4. Approval Matrix for Master File Documents


    NOTE: Not all documents may be required for the Master File.
    Prefix ID Document Type Quality Technical Production Regulatory
    Assurance
    CM Control Method LM TSM/TPM - -
    SPC Specification LM TSM /TPM - RAM
    FLN Formulation QAM TSM /TPM PM RAM
    PMS Packaging Material Specification- QAM TSM /TPM PM RAM
    Test Report
    MF Manufacturing Formula QAM TSM /TPM PM RAM
    MI Manufacturing Instruction QAM TSM /TPM PM -
    BOM Bill Of Materials QAM TSM /TPM PM -
    SS Stability Specification LM TSM /TPM - -
    FGS Finished Goods Specification LM TSM/ TPM
    - -
    and Test Report
    RMS Raw Materials Specification and LM TSM /TPM - -
    Test Report
    Keys:

    QAM Quality Assurance Manager TSM Technical Service Manager


    PM Production Manager TPM Technical Project Manager
    RAM Regulatory Affairs Manager LM Laboratory Manager
    A delegate may be authorised to sign on behalf of the nominated, responsible person.

    5. Review Period for Master File Documents


    Prefix ID Document Type Review Period

    CM Control Method 3 years unless change initiated


    SPC Specification 3 years unless change initiated
    FLN Formulation 3 years unless change initiated
    PMS Packaging Material Specification and Test Report 3 years unless change initiated
    MF Manufacturing Formula 3 years unless change initiated
    MI Manufacturing Instruction 3 years unless change initiated
    BOM Bill Of Materials 3 years unless change initiated
    SS Stability Specification 3 years unless change initiated
    FGS Finished Goods Specification and Test Report 3 years unless change initiated
    RMS Raw Materials Specification and Test Report 3 years unless change initiated

    Copyright©www.gmpsop.com. All rights reserved


    Unauthorized copying, publishing, transmission and distribution of any part of the content by
    electronic means are strictly prohibited. Page 5 of 11
    Standard Operating Procedure
    Title: Classification, Definition and Approval Matrix of GMP Documents

    Document Technical QA Dept Regulatory

    Manufacturing • Complies with registered Product Details • Reflects bulk formulations used in • Complies with registered Product Details
    Formula (MF) and other registered details production and other registered details

    • Batch size stated in line with machine • Batch size stated in line with machine
    capability and registered details capability and registered details

    Manufacturing • Complies with registered Product Details • Based on local production knowledge and
    Instruction and other registered details validation

    (MI) • Based on local production knowledge and


    validation

    Bill of Materials • Complies with registered Product Details • Based on local production knowledge and
    and other registered details validation
    (BOM)
    • Batch size stated in line with machine
    capability and registered details

    Stability • Compliance with registered Product Details Analytical Not applicable


    Specification or other registered details
    (SS) • Updated to current pharmacopoeia
    • Updated to current pharmacopoeia
    • Reflects stability of product
    • Reflects stability of product
    Raw Material • Complies with registered Product Details Analytical Not applicable
    Specification
    and Test Report • Reflects current pharmacopoeia • Reflects current pharmacopoeia

    (RMS) • Reflects current in-house specification • Reflects current in-house specification


    (where applicable) (where applicable)
    Finished Goods • Complies with registered Product Details Analytical Not applicable
    Specification
    and Test Report • Reflects current pharmacopoeia • Reflects current pharmacopoeia

    (FGS) • Reflects current in-house specification • Reflects current in-house specification


    (where applicable) (where applicable)

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    Unauthorized copying, publishing, transmission and distribution of any part of the content by electronic means are strictly prohibited. Page 7 of 11
    Standard Operating Procedure
    Title: Classification, Definition and Approval Matrix of GMP Documents

    8. Document Database for Quality Document

    Documentation Database Live

    Draft SOP

    Circulation Forms

    Obsolete QA Agreement

    Superseded Visual Display

    Under review Training Session Plan

    Templates Policy

    Status box
    Project Files

    Comment
    Manual
    Live
    Incident Meeting Minutes

    TPM Dispatch Report

    Position Paper

    Technical Files

    Standards

    Compendia

    Copyright©www.gmpsop.com. All rights reserved


    Unauthorized copying, publishing, transmission and distribution of any part of the content by
    electronic means are strictly prohibited. Page 9 of 11
    Standard Operating Procedure
    Title: Classification, Definition and Approval Matrix of GMP Documents

    10. Document Database for Audit Document

    Audit Document Database Live

    Draft Inter Quality Audit

    Circulation Vendor Audit

    Obsolete Environmental, Health and


    Safety Audit

    Superseded

    EHS Workplace Inspection


    Under review

    Housekeeping Audit
    Templates

    Status box
    Regulatory Inspection

    Master Document List

    Live

    11. Summary of Changes

    Version # Revision History


    QMS-010 New

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    Unauthorized copying, publishing, transmission and distribution of any part of the content by
    electronic means are strictly prohibited. Page 11 of 11

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