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    Annexure 1 CHANGE CONTROL RECORD

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    BlueSaga
    This document summarizes a change control record for a proposed change to an existing system. It includes sections for detailing the proposed change, conducting an impact analysis to determine how it may affect various areas, obtaining approval to implement the change, tracking action items to closure, implementing and closing out the change, and conducting post-change monitoring. The last section documents any observations from post-change monitoring and the conclusions drawn.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Annexure 1 CHANGE CONTROL RECORD

    Uploaded by

    BlueSaga
    60 views7 pages
    This document summarizes a change control record for a proposed change to an existing system. It includes sections for detailing the proposed change, conducting an impact analysis to determine how it may affect various areas, obtaining approval to implement the change, tracking action items to closure, implementing and closing out the change, and conducting post-change monitoring. The last section documents any observations from post-change monitoring and the conclusions drawn.

    Original Title

    Annexure-1-CHANGE-CONTROL-RECORD (1)

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    This document summarizes a change control record for a proposed change to an existing system. It includes sections for detailing the proposed change, conducting an impact analysis to determine how it may affect various areas, obtaining approval to implement the change, tracking action items to closure, implementing and closing out the change, and conducting post-change monitoring. The last section documents any observations from post-change monitoring and the conclusions drawn.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    60 views7 pages

    Annexure 1 CHANGE CONTROL RECORD

    Uploaded by

    BlueSaga
    This document summarizes a change control record for a proposed change to an existing system. It includes sections for detailing the proposed change, conducting an impact analysis to determine how it may affect various areas, obtaining approval to implement the change, tracking action items to closure, implementing and closing out the change, and conducting post-change monitoring. The last section documents any observations from post-change monitoring and the conclusions drawn.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 7

    ANNEXURE 1

    CHANGE CONTROL RECORD


    SECTION A:
    Date of
    CCR No.
    issuance

    Area Utility Product System Document T.C.D.


    Applicable
    to Equipment Material Instrument Other Ext. I
    Title of
    Ext. II
    Change

    Product / Reference
    material / Batch No./
    Document / AR No. /
    Instrument/ Doc. No./
    Equipment/ Equipment ID
    Area/Utility/ /Instrument
    Other ID/Area

    Previous change control form No.(if any)


    Initiated By
    (Name) Logged By
    QA (Name)
    Department
    CHANGE DETAILS
    Existing system

    Page 1 of 7
    ANNEXURE 1
    CHANGE CONTROL RECORD
    CCR No.:
    Proposed change

    Justification

    Approved by
    Initiated by
    HOD/Designee
    (Sign & Date)
    (Sign & Date)

    SECTION B:
    IMPACT ANALYSIS
    Concerned
    Impact Recommendation of Impacted Dept.
    Items Action Item No. HOD
    (Yes/No) HOD/ Designee
    (Sign & Date)
    Process

    Quality Parameter
    Calibration
    Schedule

    Page 2 of 7
    ANNEXURE 1
    CHANGE CONTROL RECORD

    CCR No.:
    Concerned
    Impact Recommendation of Impacted Dept.
    Items Action Item No. HOD
    (Yes/No) HOD/ Designee
    (Sign & Date)
    Stability
    Process
    Validation
    Cleaning
    Validation
    Training
    Information
    (As per annexure
    7)
    Hold time
    Sampling
    Regulatory
    Approval
    Mfg. product
    Lic./COPP
    Marketing
    Approval
    DCGI

    Product list
    Cleaning/
    Passivation/
    Sanitation
    Preventive
    Maintenance
    Schedule
    Equipment /
    Instrument
    Master List
    Layout/ Drawing/
    Diagram
    Segregation of the
    Area/ Caution
    Display
    Utility Impact
    Spec./ATP (RM,
    PM,FP, stability)

    Page 3 of 7
    ANNEXURE 1
    CHANGE CONTROL RECORD
    CCR No.:
    Concerned
    Impact Recommendation of Impacted Dept.
    Items Action Item No. HOD
    (Yes/No) HOD/ Designee
    (Sign & Date)
    MBMR / Mfg.
    BOM
    MBPR / Pkg.
    BOM
    SOP / Protocol
    LIMS /
    METIS/SAP
    Qualification

    Calibration
    Packing Material/
    Pack style
    Change parts /
    tooling
    Artwork
    Rejection /
    Destruction
    Price, equipment
    list
    E.H.S.(If yes
    annexure)
    Risk Assessment
    Cross function
    investigation
    report
    CAPA
    MSTG/FDD
    Comment
    Any Other

    Dep. Head
    (Sign & Date)

    Impact Analysis Review


    by QA Head /Designee
    (Sign and Date)

    Page 4 of 7
    ANNEXURE 1
    CHANGE CONTROL RECORD

    CCR No.:
    Notification Comment Sign & Date

    Plant Head

    SECTION C:
    APPROVAL FOR EXECUTION
    To be filled by QA Head/Designee
    Approved Rejected Change Review Level:  Level I  Level II  Level III
    Approved By Comment Sign & Date
    Department Head /
    Production Head

    Q.A. Head

    Site Quality Head

    SECTION D:
    ACTION ITEM CLOSURE DETAILS
    Action Item Action Item Initiator/Designee Reference Document Reviewed By QA
    Number Completion Date Sign and Date Details Sign and Date

    Page 5 of 7
    ANNEXURE 1
    CHANGE CONTROL RECORD

    CCR No.:
    Reviewed By
    Action Item Initiator/Designee Reference Document
    Action Item Number QA
    Completion Date Sign and Date Details
    Sign and Date

    ACTION ITEM CLOSURE EVALUATION


    Department Comments Sign & Date
    Department
    Head

    Quality
    Assurance

    SECTION E:
    IMPLEMENTATION AND CHANGE CLOSURE DETAILS
    Change implemented Change not implemented
    Closure comments:

    Post changes review requirement (PCRR) Yes No


    Recommendation for PCRR:

    Checked by QA Head Approved by Site Quality Head


    (Sign & Date) (Sign & Date)

    Page 6 of 7
    ANNEXURE 1
    CHANGE CONTROL RECORD

    CCR No.:
    Sign and Date

    Change control closer status:  Closed  Not implemented

    SECTION F:
    POST CHANGES AND EFFECTIVENESS MONITORING DETAILS
    Reference Tracking No.:
    Mode : APQR / Protocol / Self Inspection /
    Target Date
    CAPA
    Date & Sign
    Final Checked by
    Date Observation Ref. Doc. No.
    conclusion Sign and Date

    Documents Attached:
    1.
    2.
    3.
    4.
    5.

    Page 7 of 7

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