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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 Assurance Staff

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 and 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 Assurance Staff

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 and 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

 Upon successful completion of the installation qualification, the Final Approval Section will be
completed signifying the installation of the Weighing Booth system is acceptable and have met
specification and requirements.

1.7 Attachments

All data collection forms and equipment specifications are provided as attachments to this Protocol. These
documents will cover all necessary information required to succesed installation quality of the Weighing
Booth System.

2.0 Change Controls Procedure

Any change to the qualified equipment system should be proceeding thought a change control procedures and
should be documented. Re-qualification may be necessary to check its qualification status and named as revision
document.

PT KUSUMA PERSADA ENGINEERING 3


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 Hermed

Name Signature Initials Date

Technical Manager

Quality Assurance Manager

PT Kusuma Persada Engineering

Name Signature Initials Date

Reza Febrian

Qualification Team

Dilla Habibah

Qualification Coordinator

PT KUSUMA PERSADA ENGINEERING 4


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 Manager

Quality Assurance Manager

Operational Manager

PT KUSUMA PERSADA ENGINEERING 4


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

Technical Manager

Quality Assurance Manager

Operational Manager

PT KUSUMA PERSADA ENGINEERING 5


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

Technic

Quality Assurance Staff

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

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 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

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

Technic

Quality Assurance Staff

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

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 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

Technic

Quality Assurance Staff

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

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 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

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 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

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

Technical Manager

Quality Assurance Manager

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

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 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

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

Technical Manager

Quality Assurance Manager

PT KUSUMA PERSADA ENGINEERING 4


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

Technician

Quality Assurance

PT KUSUMA PERSADA ENGINEERING 13


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 & Maintenance


Manager

Quality Assurance Manager

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

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

Technician

Quality Assurance

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

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 & Maintenance


Manager

Quality Assurance Manager

PT KUSUMA PERSADA ENGINEERING 14


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 Manager

Quality Assurance Manager

PT KUSUMA PERSADA ENGINEERING 5


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

Technical Manager

Quality Assurance Manager

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

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 Assurance

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

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

Technical Manager

Quality Assurance Manager

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

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 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

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

Technical Manager

Quality Assurance Manager

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

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 Assurance

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

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

Technical Manager

Quality Assurance Manager

PT KUSUMA PERSADA ENGINEERING 6


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

Technic and Maintenance

Quality Assurance

PT KUSUMA PERSADA ENGINEERING 3


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

Technical and Maintenance Manager

Quality Assurance Manager

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

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

Technic and Maintenance

Quality Assurance

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

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

Technical and Maintenance Manager

Quality Assurance Manager

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

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

Technic and Maintenance

Quality Assurance

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

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

Technical and Maintenance Manager

Quality Assurance Manager

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

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

Technic and Maintenance

Quality Assurance

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

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

Technical and Maintenance Manager

Quality Assurance Manager

PT KUSUMA PERSADA ENGINEERING 4


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 Assurance Staff

PT KUSUMA PERSADA ENGINEERING 5


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 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

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 Assurance Staff

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

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 6


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 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

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 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

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 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

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 4


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

Teknik

Quality Support – QA

Analis QC

PT KUSUMA PERSADA ENGINEERING 12


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 Hermed

Name Signature Initials Date

Teknik

Engineering

Quality Assurance

PT Kusuma Persada Engineering

Name Signature Initials Date

Reza Febrian

Qualification Team

Dilla Habibah

Qualification Coordinator

Tegi Septian Hakiki

Site Project

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

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

Teknik

Quality Support – QA

Analis QC

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

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 Hermed

Name Signature Initials Date

Teknik

Engineering

Quality Assurance

PT Kusuma Persada Engineering

Name Signature Initials Date

Reza Febrian

Qualification Team

Dilla Habibah

Qualification Coordinator

Tegi Septian Hakiki

Site Project

PT KUSUMA PERSADA ENGINEERING 13

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