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    asep suparman
    4 views49 pages
    The document summarizes validation reports for HVAC and weighing booth systems at PT Hermed's Solid Hormonal Non Sterile facility. It lists the personnel responsible for executing installation qualification protocols and reports, including engineers from PT Kusuma Persada and PT Hermed. Final approval is given by managers from both companies once the reports are reviewed and systems are deemed qualified according to specifications.

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    Validasi Team n Final Approve

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    The document summarizes validation reports for HVAC and weighing booth systems at PT Hermed's Solid Hormonal Non Sterile facility. It lists the personnel responsible for executing installation qualification protocols and reports, including engineers from PT Kusuma Persada and PT Hermed. Final approval is given by managers from both companies once the reports are reviewed and systems are deemed qualified according to specifications.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    4 views49 pages

    Validasi Team N Final Approve

    Uploaded by

    asep suparman
    The document summarizes validation reports for HVAC and weighing booth systems at PT Hermed's Solid Hormonal Non Sterile facility. It lists the personnel responsible for executing installation qualification protocols and reports, including engineers from PT Kusuma Persada and PT Hermed. Final approval is given by managers from both companies once the reports are reviewed and systems are deemed qualified according to specifications.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 49

    INSTALLATION QUALIFICATION PROTOCOL

    FACILITIES HVAC SYSTEM SOLID HORMONAL NON STERILE


    AT PT HERMED

    SYSTEM : HVAC DOCUMENT NO : IQ-MP/SHNS/HMD/22


    AREA : Solid Hormonal Non Sterile REVISION : 00

    4.0 Validation Team

    The following personnel comprise the validation team who responsible for the execution of the
    Installation Qualification Protocol, visual inspection, data record and writing the Installation
    Qualification Protocol:

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Technical

    Quality Support - QA

    PT KUSUMA PERSADA ENGINEERING 7


    INSTALLATION QUALIFICATION PROTOCOL
    FACILITIES HVAC SYSTEM SOLID HORMONAL NON STERILE
    AT PT HERMED

    SYSTEM : HVAC DOCUMENT NO : IQ-MP/SHNS/HMD/22


    AREA : Solid Hormonal Non Sterile REVISION : 00

    5.0 Final Approvals

    After reviewing this Installation Qualification Protocol and its attachment, we, undersign below,
    approve that this Protocol is qualified to conform HVAC System installation and specification in
    technical specification and operation PT Hermed .

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Engineering &
    Maintenance Manager

    Quality Assurance Manager

    PT KUSUMA PERSADA ENGINEERING 8


    INSTALLATION QUALIFICATION REPORT
    FACILITIES HVAC SYSTEM SOLID HORMONAL NON STERILE
    AT PT HERMED

    SYSTEM : HVAC DOCUMENT NO : IQ-MR/SHNS/HMD/22


    AREA : Solid Hormonal Non Sterile REVISION : 00

    4.0 Validation Team

    The following personnel comprise the validation team who responsible for the execution of the
    Installation Qualification Report, visual inspection, data record and writing the Installation
    Qualification Report:

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Technical

    Quality Support - QA

    PT KUSUMA PERSADA ENGINEERING 7


    INSTALLATION QUALIFICATION REPORT
    FACILITIES HVAC SYSTEM SOLID HORMONAL NON STERILE
    AT PT HERMED

    SYSTEM : HVAC DOCUMENT NO : IQ-MR/SHNS/HMD/22


    AREA : Solid Hormonal Non Sterile REVISION : 00

    5.0 Final Approvals

    After reviewing this Installation Qualification Report and its attachment, we, undersign below,
    approve that this Report is qualified to conform HVAC System installation and specification in
    technical specification and operation PT Hermed .

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Engineering &
    Maintenance Manager

    Quality Assurance Manager

    PT KUSUMA PERSADA ENGINEERING 8


    INSTALLATION QUALIFICATION PROTOCOL
    WEIGHING BOOTH SYSTEM
    PT HERMED

    SYSTEM : Weighing Booth DOCUMENT NO : IQ-MP/SHNS-02/HMD/23


    LOCATION : Solid Hormonal Non Sterile REVISION : 00

    3.0 Validation Team

    The following personnel comprise the validation team who responsible for the execution of
    the Installation Qualification Protocol, visual inspection, data record and writing the Installation
    Qualification Protocol:

    PT Kusuma Persada Engineering

    Name Signature Initials Date


    Reza Febrian

    Qualification Team
    Dilla Habibah

    Qualification
    Coordinator

    PT Hermed

    Name Signature Initials Date

    Technical

    Quality Support - QA

    PT KUSUMA PERSADA ENGINEERING 3


    INSTALLATION QUALIFICATION REPORT
    WEIGHING BOOTH SYSTEM
    PT HERMED

    SYSTEM : Weighing Booth DOCUMENT NO : IQ-MR/SHNS-02/HMD/23


    LOCATION : Solid Hormonal Non Sterile REVISION : 00

    3.0 Validation Team

    The following personnel comprise the validation team who responsible for the execution of
    the Installation Qualification Report, visual inspection, data record and writing the Installation
    Qualification Report:

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification
    Coordinator

    PT Hermed

    Name Signature Initials Date

    Technical

    Quality Support - QA

    PT KUSUMA PERSADA ENGINEERING 5


    INSTALLATION QUALIFICATION REPORT
    WEIGHING BOOTH SYSTEM
    PT HERMED

    SYSTEM : Weighing Booth DOCUMENT NO : IQ-MR/SHNS-02/HMD/23


    LOCATION : Solid Hormonal Non Sterile REVISION : 00

    4.0 Final Approvals

    After reviewing this Installation Qualification Report and its attachment, we, undersign below,
    approve that this Report is qualified to conform Weighing Booth System installation and
    specification in technical specification and operation PT Hermed.

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification
    Coordinator

    PT Hermed

    Name Signature Initials Date

    Engineering &
    Maintenance Manager

    Quality Assurance Manager

    PT KUSUMA PERSADA ENGINEERING 4


    OPERATIONAL QUALIFICATION REPORT
    FACILITIES HVAC SYSTEM SOLID HORMONAL NON STERILE
    AT PT HERMED

    SYSTEM : HVAC DOCUMENT NO : OQ-MR/SHNS/HMD/22


    LOCATION : Solid Hormonal Non Sterile REVISION : 00

    2.0 Validation Team

    The following personnel comprise the validation team who responsible for the execution of the
    Operational Qualification Report, visual inspection, data record and writing the Operational
    Qualification Report:

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Technical

    Quality Support - QA

    PT KUSUMA PERSADA ENGINEERING 4


    OPERATIONAL QUALIFICATION REPORT
    FACILITIES HVAC SYSTEM SOLID HORMONAL NON STERILE
    AT PT HERMED

    SYSTEM : HVAC DOCUMENT NO : OQ-MR/SHNS/HMD/22


    LOCATION : Solid Hormonal Non Sterile REVISION : 00

    3.0 Final Approvals

    After reviewing this Operational Qualification Report and its attachment, we, undersign below,
    approve that this Report is qualified to conform HVAC System Operational and specification in
    technical specification and operation PT Hermed.

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Engineering and
    Maintenance Manager

    Quality Assurance Manager

    PT KUSUMA PERSADA ENGINEERING 3


    OPERATIONAL QUALIFICATION PROTOCOL
    FACILITIES HVAC SYSTEM SOLID HORMONAL NON STERILE
    AT PT HERMED

    SYSTEM : HVAC DOCUMENT NO : OQ-MP/SHNS/HMD/22


    LOCATION : Solid Hormonal Non Sterile REVISION : 00

    2.0 Validation Team

    The following personnel comprise the validation team who responsible for the execution of the
    Operational Qualification Protocol, visual inspection, data record and writing the Operational
    Qualification Protocol:

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Technical

    Quality Support - QA

    PT KUSUMA PERSADA ENGINEERING 4


    OPERATIONAL QUALIFICATION PROTOCOL
    FACILITIES HVAC SYSTEM SOLID HORMONAL NON STERILE
    AT PT HERMED

    SYSTEM : HVAC DOCUMENT NO : OQ-MP/SHNS/HMD/22


    LOCATION : Solid Hormonal Non Sterile REVISION : 00

    3.0 Final Approvals

    After reviewing this Operational Qualification Protocol and its attachment, we, undersign
    below, approve that this Protocol is qualified to conform HVAC System Operational and
    specification in technical specification and operation PT Hermed.

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Engineering and
    Maintenance Manager

    Quality Assurance Manager

    PT KUSUMA PERSADA ENGINEERING 3


    OPERATIONAL QUALIFICATION REPORT
    FACILITIES HVAC SYSTEM SOLID HORMONAL NON STERILE
    AT PT HERMED

    SYSTEM : HVAC DOCUMENT NO : OQ/MR/SHNS/HMD/22


    LOCATION : Solid Hormonal Non Sterile REVISION : 00

    2.0 Validation Team

    The following personnel comprise the validation team who responsible for the execution of the
    Operational Qualification Report, visual inspection, data record and writing the Operational
    Qualification Report:

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Technical

    Quality Support - QA

    PT KUSUMA PERSADA ENGINEERING 4


    OPERATIONAL QUALIFICATION REPORT
    FACILITIES HVAC SYSTEM SOLID HORMONAL NON STERILE
    AT PT HERMED

    SYSTEM : HVAC DOCUMENT NO : OQ-MR/SHNS/HMD/22


    LOCATION : Solid Hormonal Non Sterile REVISION : 00

    3.0 Final Approvals

    After reviewing this Operational Qualification Report and its attachment, we, undersign below,
    approve that this Report is qualified to conform HVAC System Operational and specification in
    technical specification and operation PT Hermed.

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Engineering and
    Maintenance Manager

    Quality Assurance Manager

    PT KUSUMA PERSADA ENGINEERING 3


    OPERATIONAL QUALIFICATION REPORT
    WEIGHING BOOTH SYSTEM
    PT HERMED

    SYSTEM : Weighing Booth DOCUMENT NO : OQ-MR/SHNS-02/HMD/23


    LOCATION : Solid Hormonal Non Sterile REVISION : 00

    2.0 Validation Team

    The following personnel comprise the validation team who responsible for the execution of the
    Operational Qualification Report, visual inspection, data record and writing the Operational
    Qualification Report:

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Technical

    Quality Assurance

    PT KUSUMA PERSADA ENGINEERING 4


    OPERATIONAL QUALIFICATION REPORT
    WEIGHING BOOTH SYSTEM
    PT HERMED

    SYSTEM : Weighing Booth DOCUMENT NO : OQ-MR/SHNS-02/HMD/23


    LOCATION : Solid Hormonal Non Sterile REVISION : 00

    3.0 Final Approvals

    After reviewing this Operational Qualification Report and its attachment, we, undersign below,
    approve that this Report is qualified to conform Weighing Booth System Operational and
    specification in technical specification and operation PT Hermed.

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Engineering &
    Maintenance Manager

    Quality Assurance Manager

    PT KUSUMA PERSADA ENGINEERING 3


    OPERATIONAL QUALIFICATION PROTOCOL
    WEIGHING BOOTH SYSTEM
    PT HERMED

    SYSTEM : Weighing Booth DOCUMENT NO : OQ-MP/SHNS-02/HMD/23


    LOCATION : Solid Hormonal Non Sterile REVISION : 00

    2.0 Validation Team

    The following personnel comprise the validation team who responsible for the execution of
    the Operational Qualification Protocol, visual inspection, data record and writing the
    Operational Qualification Protocol:

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Technical

    Quality Support - QA

    PT KUSUMA PERSADA ENGINEERING 4


    OPERATIONAL QUALIFICATION PROTOCOL
    WEIGHING BOOTH SYSTEM
    PT HERMED

    SYSTEM : Weighing Booth DOCUMENT NO : OQ-MP/SHNS-02/HMD/23


    LOCATION : Solid Hormonal Non Sterile REVISION : 00

    3.0 Final Approvals

    After reviewing this Operational Qualification Protocol and its attachment, we, undersign
    below, approve that this Protocol is qualified to conform Weighing Booth System Operational
    and specification in technical specification and operation PT Hermed.

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Engineering &
    Maintenance Manager

    Quality Assurance Manager

    PT KUSUMA PERSADA ENGINEERING 3


    PERFORMANCE QUALIFICATION PROTOCOL
    FACILITIES HVAC SYSTEM SOLID HORMONAL NON STERILE
    AT PT HERMED

    SYSTEM : HVAC DOCUMENT NO : PQ-MP/SHNS/HMD/23


    AREA : Solid Hormonal Non Sterile REVISION : 00

    3.0 Validation Team

    The following personnel comprise the validation team who responsible for the execution of the
    Performance Qualification Protocol, visual inspection, data record and writing the Performance
    Qualification Protocol:

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Technical

    Quality Support - QA

    PT KUSUMA PERSADA ENGINEERING 14


    PERFORMANCE QUALIFICATION PROTOCOL
    FACILITIES HVAC SYSTEM SOLID HORMONAL NON STERILE
    AT PT HERMED

    SYSTEM : HVAC DOCUMENT NO : PQ-MP/SHNS/HMD/23


    AREA : Solid Hormonal Non Sterile REVISION : 00

    4.0 Final Approvals

    After reviewing this Performance Qualification Protocol and its attachment, We the under
    signers approved that the performance qualification of the HVAC installed in solid hormone
    non sterile Facility PT Hermed are met with the predefined specification and the system can be
    used to supply the air to analysis facilities.

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Engineering &
    MaintenanceManager

    Quality Assurance Manager

    PT KUSUMA PERSADA ENGINEERING 13


    PERFORMANCE QUALIFICATION REPORT
    FACILITIES HVAC SYSTEM SOLID HORMONAL NON STERILE
    AT PT HERMED

    SYSTEM : HVAC DOCUMENT NO : PQ-MR/SHNS/HMD/23


    AREA : Solid Hormonal Non Sterile REVISION : 00

    3.0 Validation Team

    The following personnel comprise the validation team who responsible for the execution of the
    Performance Qualification Report, visual inspection, data record and writing the Performance
    Qualification Report:

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Technical

    Quality Support - QA

    PT KUSUMA PERSADA ENGINEERING 14


    PERFORMANCE QUALIFICATION REPORT
    FACILITIES HVAC SYSTEM SOLID HORMONAL NON STERILE
    AT PT HERMED

    SYSTEM : HVAC DOCUMENT NO : PQ-MR/SHNS/HMD/23


    AREA : Solid Hormonal Non Sterile REVISION : 00

    4.0 Final Approvals

    After reviewing this Performance Qualification Report and its attachment, We the under signers
    approved that the performance qualification of the HVAC installed in solid hormone non
    sterile Facility PT Hermed are met with the predefined specification and the system can be used
    to supply the air to analysis facilities.

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Engineering &
    MaintenanceManager

    Quality Assurance Manager

    PT KUSUMA PERSADA ENGINEERING 13


    INSTALLATION QUALIFICATION PROTOCOL
    HVAC SYSTEM OF RETENSI ROOM FACILITY
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : IQ-MP/RTS/HMD/22


    AREA : RETENSI ROOM REVISION : 00

    4.0 Validation Team

    The following personnel comprise the validation team who responsible for the execution of the
    Installation Qualification Protocol, visual inspection, data record and writing the Installation
    Qualification Protocol:

    PT Kusuma Persada Engineering

    Name Signature Initials Date


    Reza Febrian

    Qualification Team
    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Technical

    Quality Support - QA

    PT KUSUMA PERSADA ENGINEERING 6


    INSTALLATION QUALIFICATION PROTOCOL
    HVAC SYSTEM OF RETENSI ROOM FACILITY
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : IQ-MP/RTS/HMD/22


    AREA : RETENSI ROOM REVISION : 00

    5.0 Final Approvals

    After reviewing this Installation Qualification Protocol and its attachment, we, undersign below,
    approve that this Protocol is qualified to conform HVAC System installation and specification in
    technical specification and operation PT Hermed .

    PT Kusuma Persada Engineering

    Name Signature Initials Date


    Reza Febrian

    Qualification Team
    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Engineering &
    Maintenance Manager

    Quality Assurance Manager

    PT KUSUMA PERSADA ENGINEERING 5


    INSTALLATION QUALIFICATION PROTOCOL
    HVAC SYSTEM OF STABILITY ROOM FACILITY
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : IQ-MP/SBY/HMD/22


    AREA : STABILITY ROOM REVISION : 00

    4.0 Validation Team

    The following personnel comprise the validation team who responsible for the execution of the
    Installation Qualification Protocol, visual inspection, data record and writing the Installation
    Qualification Protocol:

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team
    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Technical

    Quality Support - QA

    PT KUSUMA PERSADA ENGINEERING 6


    INSTALLATION QUALIFICATION PROTOCOL
    HVAC SYSTEM OF STABILITY ROOM FACILITY
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : IQ-MP/SBY/HMD/22


    AREA : STABILITY ROOM REVISION : 00

    5.0 Final Approvals

    After reviewing this Installation Qualification Protocol and its attachment, we, undersign below,
    approve that this Protocol is qualified to conform HVAC System installation and specification in
    technical specification and operation PT Hermed .

    PT Kusuma Persada Engineering

    Name Signature Initials Date


    Reza Febrian

    Qualification Team
    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Engineering &
    Maintenance Manager

    Quality Assurance Manager

    PT KUSUMA PERSADA ENGINEERING 5


    INSTALLATION QUALIFICATION REPORT
    HVAC SYSTEM OF RETENSI ROOM FACILITY
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : IQ-MR/RTS/HMD/22


    AREA : RETENSI ROOM REVISION : 00

    4.0 Validation Team

    The following personnel comprise the validation team who responsible for the execution of the
    Installation Qualification Report, visual inspection, data record and writing the Installation
    Qualification Report:

    PT Kusuma Persada Engineering

    Name Signature Initials Date


    Reza Febrian

    Qualification Team
    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Technical

    Quality Support - QA

    PT KUSUMA PERSADA ENGINEERING 6


    INSTALLATION QUALIFICATION REPORT
    HVAC SYSTEM OF RETENSI ROOM FACILITY
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : IQ-MR/RTS/HMD/22


    AREA : RETENSI ROOM REVISION : 00

    5.0 Final Approvals

    After reviewing this Installation Qualification Report and its attachment, we, undersign below,
    approve that this Report is qualified to conform HVAC System installation and specification in
    technical specification and operation PT Hermed .

    PT Kusuma Persada Engineering

    Name Signature Initials Date


    Reza Febrian

    Qualification Team
    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Engineering &
    Maintenance Manager

    Quality Assurance Manager

    PT KUSUMA PERSADA ENGINEERING 5


    INSTALLATION QUALIFICATION REPORT
    HVAC SYSTEM OF STABILITY ROOM FACILITY
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : IQ-MR/SBY/HMD/22


    AREA : STABILITY ROOM REVISION : 00

    4.0 Validation Team

    The following personnel comprise the validation team who responsible for the execution of the
    Installation Qualification Report, visual inspection, data record and writing the Installation
    Qualification Report:

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team
    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Technical

    Quality Support - QA

    PT KUSUMA PERSADA ENGINEERING 6


    INSTALLATION QUALIFICATION REPORT
    HVAC SYSTEM OF STABILITY ROOM FACILITY
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : IQ-MR/SBY/HMD/22


    AREA : STABILITY ROOM REVISION : 00

    5.0 Final Approvals

    After reviewing this Installation Qualification Report and its attachment, we, undersign below,
    approve that this Report is qualified to conform HVAC System installation and specification in
    technical specification and operation PT Hermed .

    PT Kusuma Persada Engineering

    Name Signature Initials Date


    Reza Febrian

    Qualification Team
    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Engineering &
    Maintenance Manager

    Quality Assurance Manager

    PT KUSUMA PERSADA ENGINEERING 5


    OPERATIONAL QUALIFICATION PROTOCOL
    HVAC SYSTEM OF RETENSI ROOM FACILITIES
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : OQ-MP/RTS/HMD/22


    LOCATION : RETENSI ROOM REVISION : 00

    2.0 Validation Team

    The following personnel comprise the validation team who responsible for the execution of the
    Operational Qualification Protocol, visual inspection, data record and writing the Operational
    Qualification Protocol:

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team
    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Technical

    Quality Support - QA

    PT KUSUMA PERSADA ENGINEERING 4


    OPERATIONAL QUALIFICATION PROTOCOL
    HVAC SYSTEM OF RETENSI ROOM FACILITIES
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : OQ-MP/RTS/HMD/22


    LOCATION : RETENSI ROOM REVISION : 00

    3.0 Final Approvals

    After reviewing this Operational Qualification Protocol and its attachment, we, undersign
    below, approve that this Protocol is qualified to conform HVAC System Operational and
    specification in technical specification and operation PT Hermed.

    PT Kusuma Persada Engineering

    Name Signature Initials Date


    Reza Febrian

    Qualification Team
    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Engineering &
    Maintenance Manager

    Quality Assurance Manager

    PT KUSUMA PERSADA ENGINEERING 3


    OPERATIONAL QUALIFICATION PROTOCOL
    HVAC SYSTEM OF STABILITTY ROOM FACILITIES
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : OQ-MP/SBY/HMD/22


    LOCATION : STABILITY ROOM REVISION : 00

    2.0 Validation Team

    The following personnel comprise the validation team who responsible for the execution of the
    Operational Qualification Protocol, visual inspection, data record and writing the Operational
    Qualification Protocol:

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team
    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Technical

    Quality Support - QA

    PT KUSUMA PERSADA ENGINEERING 4


    OPERATIONAL QUALIFICATION PROTOCOL
    HVAC SYSTEM OF STABILITTY ROOM FACILITIES
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : OQ-MP/SBY/HMD/22


    LOCATION : STABILITY ROOM REVISION : 00

    3.0 Final Approvals

    After reviewing this Operational Qualification Protocol and its attachment, we, undersign
    below, approve that this Protocol is qualified to conform HVAC System Operational and
    specification in technical specification and operation PT Hermed.

    PT Kusuma Persada Engineering

    Name Signature Initials Date


    Reza Febrian

    Qualification Team
    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Engineering &
    Maintenance Manager

    Quality Assurance Manager

    PT KUSUMA PERSADA ENGINEERING 3


    OPERATIONAL QUALIFICATION REPORT
    HVAC SYSTEM OF RETENSI ROOM FACILITIES
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : OQ-MR/RTS/HMD/22


    LOCATION : RETENSI ROOM REVISION : 00

    2.0 Validation Team

    The following personnel comprise the validation team who responsible for the execution of
    the Operational Qualification Report, visual inspection, data record and writing the
    Operational Qualification Report:

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team
    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Technical

    Quality Support - QA

    PT KUSUMA PERSADA ENGINEERING 4


    OPERATIONAL QUALIFICATION REPORT
    HVAC SYSTEM OF RETENSI ROOM FACILITIES
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : OQ-MR/RTS/HMD/22


    LOCATION : RETENSI ROOM REVISION : 00

    3.0 Final Approvals

    After reviewing this Operational Qualification Report and its attachment, we, undersign below,
    approve that this Report is qualified to conform HVAC System Operational and specification in
    technical specification and operation PT Hermed.

    PT Kusuma Persada Engineering

    Name Signature Initials Date


    Reza Febrian

    Qualification Team
    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Engineering &
    Maintenance Manager

    Quality Assurance Manager

    PT KUSUMA PERSADA ENGINEERING 3


    OPERATIONAL QUALIFICATION REPORT
    HVAC SYSTEM OF STABILITTY ROOM FACILITIES
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : OQ-MR/SBY/HMD/22


    LOCATION : STABILITY ROOM REVISION : 00

    2.0 Validation Team

    The following personnel comprise the validation team who responsible for the execution of
    the Operational Qualification Protocol, visual inspection, data record and writing the
    Operational Qualification Protocol:

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team
    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Technical

    Quality Support - QA

    PT KUSUMA PERSADA ENGINEERING 4


    OPERATIONAL QUALIFICATION REPORT
    HVAC SYSTEM OF STABILITTY ROOM FACILITIES
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : OQ-MR/SBY/HMD/22


    LOCATION : STABILITY ROOM REVISION : 00

    3.0 Final Approvals

    After reviewing this Operational Qualification Protocol and its attachment, we, undersign
    below, approve that this Protocol is qualified to conform HVAC System Operational and
    specification in technical specification and operation PT Hermed.

    PT Kusuma Persada Engineering

    Name Signature Initials Date


    Reza Febrian

    Qualification Team
    Dilla Habibah

    Qualification Coordinator

    PT Hermed

    Name Signature Initials Date

    Engineering &
    Maintenance Manager

    Quality Assurance Manager

    PT KUSUMA PERSADA ENGINEERING 3


    INSTALLATION QUALIFICATION PROTOCOL
    HVAC SYSTEM OF MICROBIOLOGY LABORATORY FACILITY
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : IQ-MP/ML/HMD/22


    AREA : Microbiology Laboratory REVISION : 00

    4.0 Validation Team

    The following personnel comprise the validation team who responsible for the execution of the
    Installation Qualification Protocol, visual inspection, data record and writing the Installation
    Qualification Protocol:

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian
    Qualification Team

    Dilla Habibah
    Qualification Coordinator
    Tegi Septian Hakiki
    Site Project

    PT Hermed

    Name Signature Initials Date

    Technical

    Quality Support - QA

    PT KUSUMA PERSADA ENGINEERING 6


    INSTALLATION QUALIFICATION PROTOCOL
    HVAC SYSTEM OF MICROBIOLOGY LABORATORY FACILITY
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : IQ-MP/ML/HMD/22


    AREA : Microbiology Laboratory REVISION : 00

    5.0 Final Approvals

    After reviewing this Installation Qualification Protocol and its attachment, we, undersign below,
    approve that this Protocol is qualified to conform HVAC System installation and specification in
    technical specification and operation PT Hermed .

    PT Kusuma Persada Engineering

    Name Signature Initials Date


    Reza Febrian
    Qualification Team

    Dilla Habibah
    Qualification Coordinator

    Tegi Septian Hakiki


    Site Project

    PT Hermed

    Name Signature Initials Date

    Engineering &
    Maintenance Manager

    Quality Assurance Manager

    PT KUSUMA PERSADA ENGINEERING 5


    INSTALLATION QUALIFICATION REPORT
    HVAC SYSTEM OF MICROBIOLOGY LABORATORY FACILITY
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : IQ-MR/ML/HMD/22


    AREA : Microbiology Laboratory REVISION : 00

    4.0 Validation Team

    The following personnel comprise the validation team who responsible for the execution of the
    Installation Qualification Report, visual inspection, data record and writing the Installation
    Qualification Report:

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    Tegi Septian Hakiki

    Site Project

    PT Hermed

    Name Signature Initials Date

    Technical

    Quality Support - QA

    PT KUSUMA PERSADA ENGINEERING 6


    INSTALLATION QUALIFICATION REPORT
    HVAC SYSTEM OF MICROBIOLOGY LABORATORY FACILITY
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : IQ-MR/ML/HMD/22


    AREA : Microbiology Laboratory REVISION : 00

    5.0 Final Approvals

    After reviewing this Installation Qualification Report and its attachment, we, undersign below,
    approve that this Report is qualified to conform HVAC System installation and specification in
    technical specification and operation PT Hermed .

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    Tegi Septian Hakiki

    Site Project

    PT Hermed

    Name Signature Initials Date

    Engineering &
    Maintenance Manager

    Quality Assurance Manager

    PT KUSUMA PERSADA ENGINEERING 5


    OPERATIONAL QUALIFICATION REPORT
    HVAC SYSTEM MICROBIOLOGY OF LABORATORY FACILITY
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : OQ-MR/ML/HMD/22


    LOCATION : Microbiology Laboratory REVISION : 00

    2.0 Validation Team

    The following personnel comprise the validation team who responsible for the execution of the
    Operational Qualification Report, visual inspection, data record and writing the Operational
    Qualification Report:

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    Tegi Septian Hakiki

    Site Project

    PT Hermed

    Name Signature Initials Date

    Technical

    Quality Support - QA

    PT KUSUMA PERSADA ENGINEERING 4


    OPERATIONAL QUALIFICATION REPORT
    HVAC SYSTEM MICROBIOLOGY OF LABORATORY FACILITY
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : OQ-MR/ML/HMD/22


    LOCATION : Microbiology Laboratory REVISION : 00

    3.0 Final Approvals

    After reviewing this Operational Qualification Report and its attachment, we, undersign
    below, approve that this Report is qualified to conform HVAC System Operational and
    specification in technical specification and operation PT Hermed.

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    Tegi Septian Hakiki

    Site Project

    PT Hermed

    Name Signature Initials Date

    Engineering &
    Maintenance Manager

    Quality Assurance Manager

    PT KUSUMA PERSADA ENGINEERING 3


    OPERATIONAL QUALIFICATION REPORT
    HVAC SYSTEM MICROBIOLOGY OF LABORATORY FACILITY
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : OQ-MR/ML/HMD/22


    LOCATION : Microbiology Laboratory REVISION : 00

    2.0 Validation Team

    The following personnel comprise the validation team who responsible for the execution of the
    Operational Qualification Report, visual inspection, data record and writing the Operational
    Qualification Report:

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    Tegi Septian Hakiki

    Site Project

    PT Hermed

    Name Signature Initials Date

    Technical

    Quality Support - QA

    PT KUSUMA PERSADA ENGINEERING 4


    OPERATIONAL QUALIFICATION REPORT
    HVAC SYSTEM MICROBIOLOGY OF LABORATORY FACILITY
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : OQ-MR/ML/HMD/22


    LOCATION : Microbiology Laboratory REVISION : 00

    3.0 Final Approvals

    After reviewing this Operational Qualification Report and its attachment, we, undersign
    below, approve that this Report is qualified to conform HVAC System Operational and
    specification in technical specification and operation PT Hermed.

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    Tegi Septian Hakiki

    Site Project

    PT Hermed

    Name Signature Initials Date

    Engineering &
    Maintenance Manager

    Quality Assurance Manager

    PT KUSUMA PERSADA ENGINEERING 3


    PERFORMANCE QUALIFICATION PROTOCOL
    HVAC SYSTEM MICROBIOLOGY OF LABORATORY FACILITY
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : PQ-MP/ML/HMD/22


    AREA : Microbiology Laboratory REVISION : 00

    3.0 Validation Team

    The following personnel comprise the validation team who responsible for the execution of the
    Performance Qualification Report, visual inspection, data record and writing the Performance
    Qualification Report:

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    Tegi Septian Hakiki

    Site Project

    PT Hermed

    Name Signature Initials Date

    Technical

    Quality Support – QA

    Analis QC

    PT KUSUMA PERSADA ENGINEERING 13


    PERFORMANCE QUALIFICATION PROTOCOL
    HVAC SYSTEM MICROBIOLOGY OF LABORATORY FACILITY
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : PQ-MP/ML/HMD/22


    AREA : Microbiology Laboratory REVISION : 00

    4.0 Final Approvals

    After reviewing this Performance Qualification Report and its attachment, We the under signers
    approved that the performance qualification of the HVAC installed in Microbioilogy Of
    Laboratory Facility PT Hermed are met with the predefined specification and the system can be
    used to supply the air to analysis facilities.

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    Tegi Septian Hakiki

    Site Project

    PT Hermed

    Name Signature Initials Date

    Engineering &
    Mainteance manager

    Quality Assurance Manager

    PT KUSUMA PERSADA ENGINEERING 12


    PERFORMANCE QUALIFICATION REPORT
    HVAC SYSTEM MICROBIOLOGY OF LABORATORY FACILITY
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : PQ-MR/ML/HMD/22


    AREA : Microbiology Laboratory REVISION : 00

    3.0 Validation Team

    The following personnel comprise the validation team who responsible for the execution of the
    Performance Qualification Report, visual inspection, data record and writing the Performance
    Qualification Report:

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    Tegi Septian Hakiki

    Site Project

    PT Hermed

    Name Signature Initials Date

    Technical

    Quality Support – QA

    Analis QC

    PT KUSUMA PERSADA ENGINEERING 13


    PERFORMANCE QUALIFICATION REPORT
    HVAC SYSTEM MICROBIOLOGY OF LABORATORY FACILITY
    PT HERMED

    SYSTEM : HVAC DOCUMENT NO : PQ-MR/ML/HMD/22


    AREA : Microbiology Laboratory REVISION : 00

    4.0 Final Approvals

    After reviewing this Performance Qualification Report and its attachment, We the under signers
    approved that the performance qualification of the HVAC installed in Microbioilogy Of
    Laboratory Facility PT Hermed are met with the predefined specification and the system can be
    used to supply the air to analysis facilities.

    PT Kusuma Persada Engineering

    Name Signature Initials Date

    Reza Febrian

    Qualification Team

    Dilla Habibah

    Qualification Coordinator

    Tegi Septian Hakiki

    Site Project

    PT Hermed

    Name Signature Initials Date

    Engineering &
    Maintenance Manager

    Quality Assurance

    PT KUSUMA PERSADA ENGINEERING 12

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