m

KOTRA
KOTRA PHARMA (M) SDN BHD
Operational Qualifi cation Protocol
(sooaz-v)

uv/oQP/B/O93

OPERATIONAL QUALIFICATION PROTOCOL

Title: CLEANRO OM M-ONTIORn{G SYSTEM
Bos- t24 (BLo€atgrtRILE, GEL)
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Document No.: uv/oQP/P/yl

Revision No.: 00

Reviewed bv:

Designation Name Signature f)ate

System Engineer t R. Ganapathi -/

Facility & Engineering
" r
Manager '{ Sarj Kumar ;
Assistant IT Manager ,/ Peter Chin /
Technical Manager ,r' Thawaraj Parimanam .,,

Production Manager / Nor Azman Sahad /

Assistant QC Manager * re*r,av@1*)"
Validation Manager Makrand Vijay Mhaskar I
Plant General Manager / Jimmy Piong f

Reviewed and approved by:

Designation Name Signature Date

QA Manager Anderson Lim Kit Yiap

uv/oQP/B/093
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Document Title: Operatiotral Qualificarion J LWS Documenr Number: LMS,OR10243-OO-001 B05-124 DocumentTitle: Operational Qualification I LWS Document Number: LMS-OR10243-OO-001 B05-124
Customer: Kotra Pharma fM) Sdn. Bhd. No.1. 2 & 3. Ialan TTC 12. Chens Industriat Estate. 75250 Melaka Mala Customefl Kotra Pharma rM) Sdn. Bhd. No. 1. 2 & 3. Ialan TTC 12. Chens Industrial Esrate 752So Melak, Mal,
Proiect Cleanroom Monitorins Svste Date: SEP 19,2014 Proiect (;lpanronm Mnnlirrlne Svstem Date: SEP 19,2014
LWS Prepared by: Benneth 6oh LWS Department: Service LWS Prepared by: gsnnslS Goh LWS Department: Service

Final Report Review & Approval:

Revision History
Benneth Goh
Revisioh Dete. I Implemented bg Details,
0 IZMACL4 Masrul First Draft Benneth Goh
sysr.nr EnEinc.r{KPl
1 19SEP14 Benneth Second Draft
z R. Ganapathi
tsacurry & Eng'necnng Mrmgor (KPll
3
Sari Kumar
Produdron Manasd (KP)l

Document Review & Approval: Nor Azman sahad

Asastant IT Mahas.. {KP)

Peter Chin
'lc.hnical M!nq.r iKPl:

Benneth Goh Thawaraj Parimanam

Assr$atrt quartry conuot Min)gc. ((p)

Benneth Goh Tew Lav Tan

v.lnlarion Manascr IKPl:

R. Ganapathi Makrand Viiav Mhaskar

Facilfty & Engnrccring Mrnagc. (KP)
Quality Assur.tr.c Manag.r ((P):

Sari Kumar Anderson Lim KitYiaD

Productjon Man.se.(KP) Prrnrccncrar Managcr (Kpll

Nor Azman Sahad Jimmy Pione

Asis*antlT Manascr ((P)

Peter Chin
Tehnical Managc.((Pl

Thawarai Parimanam
Assstant Qualtry conff ol MaDagc. (KPJI

Tew Lay Tan

yar'danon Managcr (KP):

Makrand Viiav Mhaskar

Qualty Assu.!nce Managcr {KP)l

Anderson Lim Kit YiaD

Plantcener.l Managcr (KP):

Iimmv Piono
Lighthouse Woaldwide Solutions Company Confidential Lighthouse Worldwide Solutions Conpany Confident,al
47300 Kalo Road 'I his document may not be reproduced, copied, or distributed without written permission 47300 Kaio Road
h om This document may notbe reproduced, copied, or distributed without writen permission from
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B05-124 STERILE GEL 805,124 STERILE GEL
Document Titler Ope.ational Qualification
=r
I LWS Document Number: LMS-OR10243-Oe-001 B05-124 Document Title: Opemtional Qualification I LWS Document Number: LMS-OR10243-OQ-001 BO5-124
Customer: Kotra Pharma [M) Sdn. Bhd, No. 1,2 & 3, la]an TTC 12, Chens Industrial Estate.752S0 Melaka. Malavsia
ProjecL Cleanroom Monitorins Svstem Date: SFP '19 20'14 : Cleanroom Monitorins SvslF Date:SF:P1g 201
LWS Prepared by: Benneth Goh LWS Departmenl Service LWS Prepared by: Benneth Goh LWS Depaftment: Service

Table ofContents

5.3 System Floor Plan [Map and Sensor Locations)........"................... ....""....................10

5.5 System Data Collection Redundancy..".... ....................................10

5.7 Room Temperature / Relatrve Humidity Sensors............................... ."..................11

6.2 Test Progress Report Signatures..............,........... ............"...........16

6.7 System Data Collectron Redundancy....... ...................._........_......28

6.9 Room Temperature / Relative Humidity Sensor ....................33

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This document may notbe reproducecl, copied, or distributed withoutwritten permission from 4730O Kalo Road This document may not be reproduced, copied, or distributed withoutwritten permission from
Lighthouse Worldwide Solutions. Fremont, CA 94538 USA
Lighthouse Worldwide Solutions.
(510) 438,0500 TEL
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ffi LTCHTHOUST
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OPERATIONAL QUATIFICATION (OQ)
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OPERATIONAL QUATIFICATION (OQ)
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Page 6 ofTZ

Document Title: Operational Qualification I LWS Document Number: LMS-OR10243-OQ-001 805-124 Document Title: Operational Qualification I LWS Document Numben LMS-OR10243-OQ-001 805-124
Customer: Kotra Pharma IMl Sdn. Bhd, No. 1,2 & 3, Ialan TTC 12, Chens Industrial Estate, 75250 Melaka, Malaysia Customer: Kotra Pharma tMl Sdn. Bhd, No. 1. 2 & 3. Ialan TTC 12, Chene IndustriaL Estate.75250 Melaka. Malaysia
Proiecl Cleanroom Monitorins Svstem Date: SEP 19.2014 Proiecti Cleanroom Monitorins Svstem Dare: SEP 19.2014
LWS Prepared by: Benneth Goh LWS Department: Seruice LWS Prepared by: Benneth Goh LWS DeDartment: Seruice

1.0 Introduction 4.0 Overview and Test PIan

This document details the tests that are required to verify that all equipment and
detailed within the Functional Specification [LMS-0R10243-FRS-102J and the Design
Specification (LMS-0R10243-SDS-107J operate as required.
These tests are to be conducted upon completion of the Installation Qualification Protocol
LMS-0R10243-lQ-111-805-124 and Final report. This document contains
rationale, protocols and resuits.
Test personnel should have a good understanding ofthe LMS Pharma monitoring software,
system and particle counters.
This Operational Qualification has been generated in accordance with the International
Society for Pharmaceutical Engineering (ISPEJ current Good Automated Manufacturing
Practice (cGAMPl forum guide.
).3
E&AF'
This document shall be produced/reviewed by the Project Lead designated in this
document and, upon approval, shall be submitted to the Customer for final review and
approval. Upon completion of the testing and issuance of the final report by LWS, Final
Report approvals shall be documented in the Final Report Review & Approval section.
the test Before these test procedures are commenced, LWS shall complete all Installation
Qualification testing, the IQ Final Summary Report.
A procedure shall be deemed to have "passed" if, and only if, every step in the procedure
results in the specified outcome. If any step in a procedure results in an outcome other than
the specified resulg whereas involving documentation only, that entire procedure shall
"passed with minor deviation" and will require a "Test lncident Report" to be issued. If any
step in a procedure results in outcome other than specified result, whereas involving
functionality test of the system, that entire procedure shall fail" and will require a "Test
Incident Report" to be issued.

overview
7'.$\*kg
2.0
.,<
This protocol documents the ay'ryities and criteria used to verilyy'at the Lighthouse
Monitoring System installed at{Kotra Pharma [M) SDN.BHD, No.1,/]alan TTC 12, Cheng
lndustrial Estate, 75250 Melaka, Malaysia operates according to Kotra Pharma and LWS
requirements. The tests do not verify the system components and installation. These are
tested as part ofthe Installation Qualification. The Operational test qualification will test
the functionality of the software and hardware.
Upon completion of the testing withrn this protocol, LWS will generate a final summary
report to summarize the activities.
3.0 Reference Documents
. LMS-0R10243-FRS-102, Functional Requirement Specification
. LMS-0R10243-SDS-107, System Design Specification
. LMS-0R10243-lQ-111-805-124, lnstallation Qualification
. GAMP 5: A Risk Based Approach to Compliant GxP Computerised System, 2008
o Transmission List
W
After completion ofthe Operational Qualification, a review shall be convened, and the Test
Progress Report and any other relevant items shall be discussed. Special attention shall be
given to any "comments" entered in the Test Progress Report. The Test Progress Report
shall be signed and dated by the Tester and Witness. A Customer Representative will
attend the Review, and his or her signature shall appear in the "Customer Witness" block
on the Test Progress Report. Upon conclusion of the Review, a Review Report shall be
completed and included in Section B, "Reviews," of this document.
The personnel required to perform these test procedures shall consist of at least one
"Tester" and at least one "Witness." The Tester shall place his or her initials in the "lnitials"
block of each procedure step which is completed (irrespective of whether the test step met
the acceptance criteriaJ, and the Witness shall place his or her initials in the "Witness
lnitials" blank of each procedure which is completed [irrespective of whether the test
procedure was completed successfully). All initials may be entered electronically on a soft
copy of this document. If this method is selected a Signature page fSection 4.1..1] must be
used containing the handwfitten initials and signatures of the Tester and Witness.
Upon completion of each procedure, the Tester shall make an entry in the appropriate area
of Section 6.1, "Test Progress Report." The entry shall include the date that the Test was
completed, the "run" number of the Test, the result of the Test ["pass" or "passed with
minor deviation" or "fail"), any relevant comments, and the Tester's initials.

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This document may not be reproduced, copied, or distributed without written permission ftom 47300 Kato Road This document may notbe reproduced, copied, or distributed withoutwritten permission from
Lighthouse Worldwide Solutions. Fremont. CA 94538 USA Lighr]louse Worldwide Solulions.
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DocumentTitle: Operational Qualification
805.124 sTERILE CEL

I LWS Document Number: LMS-OR10243-OQ-001 805-124

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DocumentTitle:OperationalQualification
805.124 STERILE GEL

lLWSDocumentNumber:LMS-OR10243-OQ-001B05-124
Customer: Kot.a Pharma fMl Sdn. Bhd. No. 1.2 & 3. Ialan TTC 12. Chens Industrial Estate 75250 Melaka Mala Customer: Kotra Pharma fMl Sdn. Bhd, No. 1, 2 & 3, JalanTTC 12, Chenq Industrial Estate,75250 Melaka, Malaysia
Proiect Cleanroom Monitoring Svste Dare: SEP 1 g 201 4 ProiecL Cleanroom Monitorine Svstem Date: SEP 19.2014
LWS Prepared by: Benneth Goh LWS Departmenl Sewice LWS Prepared byr Benneth Goh LWS DepartmenL Sewice

If, for whatever reason, a test cannot be sucbessfully completed then a Test Incident Report 4.1.1 Test Personnel Details
must be raised. Full details of the incident must be recorded such that, after review by the
supplier and customer, a decision can be made on how best to resolve the issue. When the AII personnel performing documented activities in this protocol are to read the instructions
incldent has been concluded, the test must be re-run. The Test [ncident Reports and they are to follow and document in the table below that they understand them. The table
subsequent retesting documentation will be retained in Section 7 ofthis document. below is the signature page of the tester and witness.
Namh $CI.Prria$y. siel-r,3-tlIF rnlrirts lElte.i
4.1 Test Equipment Details
The test require of calibrated sensor to be checked such as Remote Particle Counter
(Lighthouse /5704V), Temp/RH [Vaisala/HMT100), Air Velocity (E+E Electronik/EE66),
Differential Pressure [Veris Industries/PLX01) and Air Flow Meter (Aalborg/GFM37J.
The equipment used to perform the tests must be recorded in the following table. AII
instruments used to document testing in this protocol must be calibrated. A copy of the
relevant calibration certificate shall be attached to the completed protocol. Document any
additional test equipment in the blank rows provided.

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Document Title: Operational Qualification

B05.124 STERII,E 6EI,

I LWS Document Number: LMS-OR10243-0Q-001 B05-124

Customer: Kotra Pharma (M) Sdn. Bhd, No. 1,2 & 3, Ialan TTC 12, Chens Industrial Estate.75250 Melaka. Malavsia
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Operational Qualification
B05-124 STERILE GEL

I LWS Document Number: LMS,OR10243-00-001 805-124

Customer: Kotra Pharma (M) Sdn. Bhd, No. 1, 2 & 3, Ialan TTC 12, Cheng Industrial Esrate,7525O Melaka, Malaysia
Proiect Cleanroom Monitorins Svstem Date: SF:P 19 201 Proiect Cleanroom Monitorins Svstem Dare: SEP 19.2014
LWS Prepared by: Benneth Goh LWS Departmentl Seruice LWS Prepared by: Benneth Goh LWS Department: Seruice

5.0 Rationale
It is important to verify that each of the functional requirements Iisted within the User
Requirement Specification [URSJ have been fulfilled. This section wi]l take each of the
listed requirements and state how the requirement has been fulfilled and how it will be
Users belonging to the Administrator Group are allowed to configure the monitoring system and
have full access and control ofthe system. Can view, edit, print, change, configure settings,
disable or enable sensor at all areas.
Users belonging to the Power User Group are allowed to view, print edit (add in batch number),
reset and acknowledge alarms at respective area only.

tested.
0nly one successful test run is required. Additional test runs may be required should the
initial test run fail due to abnormal environmental conditions.
5.1 System Power Up
It is important that the computers power up automatically with the correct software and
configuration loaded, and starts to log data. (Test Reference: LMS/0Q/11
5.2 System Security
Itisimportantthatthesystemispasswordprotected. Therearefourbasicuserlevelgroupsin
the system: Administrators, Manager, Supervisor and Operators. Within those accounts each user
can havc lurther permission reslrictions
Users belonging to the Operators Group are allowed to vie\ir', print at respective area only.
This test will establish that the system access (logging onl is restricted to users with
correct privileges and that new users can be configured and access permissions set by the
System Adminrstrator (Test Reference: LMS/OQ/2J
5.3 System Floor Plan (Map and Sensor Locations)
The View CIient application can display a facility floor plan showing specific sensor
locations and their current status. A test will be preformed to show this ability in the
software. (Test References: LMS/OQ/31
5.4 Provide Client PC Access
The LMS Pharma software provides client access for data viewing or configuration. The
system will be tested to verify this client access is functional.

[Test References: LMS/OQ/a)

Administrator

5.5 System Data Collection Redundancy

A separate PC will be setup as a Backup Server to act as a redundant data collection
machine in the event of a system failure. Failover tests will be run to veriE/ the systems
ability to recover from a failure. (Test References: LMS/OQ/S]

47300 Kaio Road
Fremont. CA 94538 USA
(s10) 4s8-0500 TEL
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]M.qoliOhlhouse.com
Liqhthouse Wo.ldwide Solulions Company Coafidential Lighthouse Worldwide Sqlutions Companv Confidential
This document may not be reproduced, copied, or distributed without written permission from 47300 Kato Road This document may not be reproduced, copied, or distributed without written permission ffom
Lighthouse Worldwide Solutions. Fremont. CA 94538 USA
Lighthouse Worldwide Solutions.
(510) 4s8-0500 TEL
(s1 0) 438-3840 FAX
vlw.goliqhthouse.com
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Document Title: Operational Quaiification I LWS Documenr Number: LMS-OR10243-OQ-001 805-124 DocumentTirle: Operariondl 0ualificalion I LWS Document Numben L\4S-ORt0243-OO.0018O5.124
Customer: Kotra Pharma (M) Sdn. Bhd, No. 1,2 & 3, lalan TTC 12. Chene Industrial Estate.75250 Melaka. Malavsia Customer: Kotra Pharma IM) Sdn. Bhd, No. 1, 2 & 3, Ialan TTC 12, Chenq Industrial Estate, 75250 Melaka, Ma]avsi
ProiF.t. Cle2nroom Monitorine Svste Datp:SEP19 20'14 Proiect: Cleanroom Monitorins System Date: SEP 19.2014
LWS Prepared byr Benneth Goh LWS Departmentr Service LWS Prepared by: Benneth Goh LWS Department: Seruice

5.6 Remote Particle Counters 5.l1Viable Samplers

Two (21 Lighthouse remote pafticle counters (model# Remote 5104V1 will be tested Two [2) Veltek SMA Atriums will be tested during the OQ. Each Viable Sampler must be
duringthe0Q. Eachparticlecountermustbeverifiedtoconfirmthatthecorrectmodel verified to confirm that the correct model has been supplied. Tests are to be conducted to
hasbeensupplied. Testsaretobeconductedtoensurethattheequipmentiscorrect. ensure that the equipment is correct. [Test References: LMS/OQ/11J
[Test References: LMS/0Q/6]

5.12 Alarm Indicators

5.7 Room Temperature / Relative Humidity Sensors
One (1J Patlite WEP-302TFB will be tested during the 0Q. Each Alarm Indicator must be
Two [Z] Vaisala Humidity and Tsrnpsl2lure HMT100 sensors will be tested during the verified to confirm that the correct model has been supplied. Tests are to be conducted to
0Q. Each Temperature / Relative Humidity must be verified to confirm that the correct ensure that the equipment is correct. (Test References: LMS/OQ/12)
model has been supplied. Tests are to be conducted to ensure that the equipment is
correct. [Test References: LMS/0Q/7]
5.13 Reports and Trends
5.8 Air Velocity Sensors The test will verify that reports can be generated and saved, that Trends Graphs can be
created, and that the data reported in Reports and Trends Graphs is the actual data
0ne[1JE+EElektronikEE66AirVelocitysensorswillbetestedduringthe0Q. EachAir collected. [Test References: LMS/OQ/].3J
Velocity sensor must be verified to confirm that the correct model has been supplied.
Tests are to be conducted to ensure that the particle counter equipment is correct.
5,14 Calibration Report
[Test References: LMS/OQ/B)
Itis important for the system to alert the calibration date period following the due date of
each sensor. The system will have a report to end user to view and the near due sensor
5.9 Differential Pressure Sensors will be highlighted starting one month before the calibration is due.
Three [3] Veris PX Series differential pressure sensors will be tested during the OQ. Each (Test References: LMS/OQ/1al
differential pressure sensor must be verified to confirm that the correct model has been
supplied. Tests are to be conducted to ensure that the equipment is correct.
5.15 Cleanroom States
(Test References: LMS/0Q/9)
The Cleanroom States Test is to verifi/ that the Cleanroom states changes, including At
Rest Disinfection, In Operation, No Production, reflects the correct cleanroom state, with
5.10 Air Flow Sensors proper alarm Iimits and vacuum pump behavior. (LMS/OQ/151
Two (2] GFM mass flow meters will be tested during the OQ. Each Air Flow Sensor must
beverifiedtoconfirmthatthecorrectmodelhasbeensupplied. Testsaretobeconducted
to ensure that the equipment is correct. [Test References: LMS/OQ/10J

47300 Kato Road
Fremont. CA 94538 USA
(s1 0) 438-0500 TEL
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This document may not be reproduced, copied, or distributed without written permission from 47300 Kaio Road This document may not be reproduced, copied, or distributed without wriften permission fuom
Lighthouse Worldwide Solutions. Fremoni. CA 94538 USA Lighthouse Worldwide Solutions.
(510) 438-0s00 TEL
(s10) 438-3840 FAX
ww,goli0hthouse.com
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Document Title: Operational Qualification I LWS Document Number: LMS-OR10243-OO-001 805-124 QualiFication I LWS Document Numben LMS-oR10243-00-001 805-124
Document Titler Operational
Customer: Kotra Pharma (Ml Sdn. Bhd, No. 1, 2 & 3, lalan TTC 12, Cheng Industrial Estare, 75250 Melaka, Malaysia Customer: Kotra Pharma IM) Sdn. Bhd, No. 1,2 & 3, Jalan TTC 12, Cheng lndustrial Estate,75250 Melaka, Malaysia
Proiecb Cleanroom Monitorins Date: SEP 19.2014 Proiect: Cleanroom Monitoring Svstem Date: SEP 19.2014
LWS Prepared by: Benneth Goh LWS Department: Service LWS Prepared by: Benneth Coh LWS Department: Service

5.16 Vacuum Pump 6.0 Operational Qualification Tests

This test is to verify the pump can be controlled by manual control through software
interface. (LMS/0Q/161 LMS/0Q/1 System Power Up

LMS/0Q/2 System Security

5.17 System Alarms LMS/0Q/3 System Floor Plan [Map and Sensor Locations]

The System Alarms test will establish the ability of LMS Pharma software to indicate real LMS/oQ/4 Provide Client PC Access
time alarms by way of color changes as a result of out of specification environmental LMS/0Q/s System Data Collection Redundancy
conditions, and instrument malfunctions. The ability of the software to log the alarms will
betested. tLMS/0Q/171 LMS/0Q/6 Remote Particle Counters

LMs/oQ/7 Room Temperature / Relative Humidity Sensors

5.18 EMAIL Notification LMS/0Q/8 Air Velocity Sensors
The System Alarms test will establish the abilily of LMS Pharma software to send an email LMS/0Q/e Differential Pressure Sensors
notification to user as a result of out of specification environmental conditions, and
LMS/0Q/10 Air Flow Sensors
instrument malfunctions. The ability ofthe softvvare to send the alarms notification
through email will be tested. ILMS/0Q/18) LMS/0Q/11 Viable Samplers
LMS/oQ/12 Alarms Indicator
5,19 SPC
LMS/0Q/13 Report and Trends
The System Alarms testwill establish the ability of LMS Pharma software to indicate real LMS/oQ/t4 Calibration Report
time alarms by way of color changes as a result of out of specification environmental
conditions, and instrument malfunctions based on Statistical Process Control [SPC]. The LMS/oQ/1s Cleanroom States
ability of the softlyare to log the alarms based on number of alarm condition will be LMs/oQ/16 Vacuum Pump
tested. (LMS/0Q/19J
LMS/oQ/77 System Alarms
LMs/oQ/18 Email Notification
5.20 GHOST Recovery ls.o LMS/oQ/1e SPC
To create backup hard disk using GHOST Sotrware u"..,(ilDi}d
restore image
LMS/oQ/20 GHOST Recovery
again to the disk to verify so[tware have no problem and )tso-Iqyeri4y'data recording will
be resuming after the system is up. [LMS/0Q/20]

For testing purposes, it is acceptable to change the sampling or alarm parameters ofthe
configured Sample Points and/or Units. The tester must ensure that any changed
parameters are reset to their original values.

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'[his document may not be reproduced, copied, or distributed withoutwritten permission from 47300 Kato Road This document may not be reproduced, copied, or distributed without written permission from
Lighthouse Worldwide Solutions. Fremont, CA 94538 USA
Lighthouse Worldwide Solutions.
(510) 438-0500 TEL
(510) 4s8-3840 FAX
ww.golighthouse-com
 &eAs,.r u
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BO5-124 STERI],E GEI-
Page 16 of72

DocumenLTitle:OperarionalQudlification lLWSDocumenrNumber:LMS-OR10243-OQ-001B05-I24 Document Title: Operational Qualification I LWS Document Numben LMS-OR10243-OQ-001 805-124
Customer: Kotra Pharma IMl Sdn. Bhd, No. 1, 2 & 3, Ialan TTC 12, ChenE lndustrial Estate. 75250 Melaka. Ma]avsia Customer; Kotra Pharma fMl Sdn. Bhd, No. 1, 2 & 3, Ialan TTC 12, Chenq lndustrial Estate,75250 Melaka, Malavsia
ProiecL Cleanroom Monitoring System Dare: SEP 19.20.14 Proiecti Cleanroom Monitorins Svstem I Date: SEP 19.2014

LWS Prepared by: Benneth Goh LWS Departmenl Service LWS Prepared by: Benneth Goh LWS Department: Seryice

6.2 Test Progress Report Signatures

6.1 Test Progress Report
[e.,...q!:ftsf€r:encf .;ii
![Hsl Rri4r+l ::i :: rt :: rT-ast Rlirr.Si2.::= ii iJi Pgst:Rn+#.3 ,il
IRdsult/D5tallri iri;trt , aladaiiIfl rlnTc fi ritli;H:
f Riirtrlt lDate llnitialil
LMS/0Q/1
LMS/oQ/2
LMS/oQ/3
LMS/0Q/4
LMS/0Q/s
LMS/0Q/6
LMS/oQ/7
LMS/oQ/8
LMS/0Q/e
LMS/0Q/10
LMS/OQ/11
LMS/oQ/12
LMS/0Q/13
LMS/0Q/14
LMS/oQ/1s
LMS/oQ/16
LMS/oQ/17
LMS/0Q/18
LMS/oQ/1e
LMS/0Q/20

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This document may not be reproduced, copied, or distributed without written permission from 47300 Kato Road This document may not be reproduced, copied, or distributed without written permission from
Lighthouse !Vorldwide Solutions. F.emont, CA 94538 USA Lighthouse Worldwide Solutions.
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# LICHTHOUSE
llt0fl t Dv,r0E 50tllIt0fl t
oPERATTONAL QUALTFTCATToN (oQ)
BO5-124 S']'ERILE GEL
Page77 of72 #
:er
LTGHTHOUSE
I'j0f, 101#l 0 t 50t |J Il0N5
OPERATIONAL QUALIFICATION (OQ)
B05.124 STERILE GEL
Page LB of72
-M
DocumeniTirle: Operational Qudlification I LWS DocumentNumber: LMS-OR10243.OO.001 805-I24 DocumentTirle:OperatlonalQualificdtion lLWSDocumentNumber:LMS-OR10243-00-001805-l'24
Customer: Kotra Pharma (Ml Sdn. Bhd, No. 1, 2 & 3, Ialan TTC 12. Chens lndustrial Estate, 75250 Melaka, I ustomer: Koira Phar md (14) Sdn. Bhd, No 2 Ialan TTC 12, Chene Industrial Estate,75250 Melaka, Malaysia
ProiecL Cleanroom Monitorins Svstem Date: SEP 19.2014 Proiect Cieanroom Monitorine SVstem Date: SEP 19,2014
LWS Prepared by: Benneth Goh LWS Department: Seruice LWS Prepared by: Benneth Goh LWS Department: Sewice

6.3,2 System Power Up / Power Down / Power Failure Test Comments

6.3 System Power Up Result: _ (passed/ passed with minor
deviation/ failed) Witness Initials:
Test Reference: LMS/OQ/1
Test Incident number: Date:
Performed by: Title: ffi18r1ffi*s.ii{id na,t :,si$EJcatffiirh:ii,6'6* fi ilfiiii. 4{i., :

i,3.1" Systilm P.oWCr.:Un /=,Power.Doiln;/ FowCr-::Fail ure Test Ta bl e

, .:::] :Siiebifidd:Eesulti i r::= AQtlal.Result: Viirined gt:
LLt Spedfied Result & Verifi@tion Method ii l{eeEIpgJifiedReill! Initial/Date by
I rjri]':rY8'/.N; i :i::j::

1. tsootuptheLMSPharma -MS Pharma Seruer and Configuration

Server and verify that the y'iewstation must start correctly,
LMS Pharma View Client
interface starts..
2. Verify the time and date )ate and time of the computer and LMS
is correcL lharma application are confirmed and are
Nithin 1 minute of that of a cell phone with
ruto uDdatine time.
3. Record the time that you -MS Pharma application and LMS Pharma
exit the LMS Pharma ;eryer must shutdown. Record the date and
application and :ime thatthe LMS Pharma application was
shutdown the LMS :urned off in the result section.
Pharma Seryer.
Re-start the LMS Pharma -MS Pharma Setrer and Configuration
Seruer, restart the y'iewstation must re-start correctly. Document
Configuration :he date and time that the LMS Pharrra
ViewStation software, tpplication restarted in the results section.
and verify that the
aDoiication re-starts.
Log onto the system and y'erify the date and tim e of the computer and
confirm the time and -MS Pharma application to confirm agreement
dith the cell Dhone.
Simulate the incomint System supply will be taking over by
supply interruption t( while waiting Auto changer over
the svstem. Generator. Svstem workins as normal.

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LICHTHOUSE,
wof,r"o,r,roE sortlnolr
oPERATTONAL QUALTFTCATIoN (OQ) Page !9 of 72 LTCHTHOUST oPERATToNAL QUALTFTCATTON (OQ) Page 20 of 72

:ustomer: Kotra Pharma fMl Sdn. Bhd, No.

5

n
Docume nt Title: Opera ti ona I Qualifi catio
BO5-124 STERILE GEL

I LWS D ocu m en r N umber: LMS-OR1 0 243,00-0 0 1 805 - 1 24

=
ffi!
Document
Yi0nL0]til !f 50tljIt0}ls
Title: Operational Qualification
805,124 STERILE GEL

I LWS Documenr Number: LMS-OR10243-OO-001 805-124

:1., 2 & 3. Ialan TTC 12. Chens Industrial Estate.75250 Melaka Mala CustomeI Kotra Pharma IM) Sdn. Bhd, No. 1, 2 & 3, Ialan TTC 12, Cheng Industrial Estate,7525O Melaka, Malaysia
ProiecL Cleanroom Monitorins Svstem Proiect: Cleanroom Monitorins Svstem Date: SEP 19,2014
LWS Prepared by: Benneth Goh LWS Departmentt Seryice LWS Prepared by: Benneth Goh LWS D€'partmenl Seryice

6.4 System Security 1 Security Test Table

Test Reference: LMS / OQ/z Run Number:

3. Close the LMS Pharma
Configuration Viewstation. Start
Performed by: Title: the Configuration ViewStation
again, and log on as the newly
i.4.1 Security Test Table confi gured [Testoperator] and
login of this new user, the
must force the user to
their password.
system must allow the User lD:

1. Start LMS Pharma Configuration
Viewstation application, iog on as
Administrator with administrator
priyileges, and close the application
window. Verify thatthis use. has
ail administrator privileges
configured.
In the database tree, copy the
'Configuration.Users.Templates-
>Default Operator, copy and paste
into the same folder, rename it into
(TestOperator) Double-click on
Testoperator in the database tree
to edit the account. Set the
Password to [Test]. Verily the
system requires a minimum 6
character password. Veriry the
password is accEpted. Ensure the
Pre-expired check box is selected to
force this user to change the
password on initial Iogin. Ve.ify
that the home page is set to the
facility overyiew djsplay. Verify
that the Group 1 field is set to
"Operators"; this wili apply the
Operator group permissions to the
new user. Click on the Viewx Tab
and make sure this user does NQT
have permission for any ofthe
items in the Configuration section.
Click File and Save to save
Test[)nerrtor
':r.,sqcss
ri",t.o,::i*1If,:,ll*,Xfl
lti
llld"*
[he Administrator shall have ali
a rdminist.ator privileges.
Testoperatorl will configured be
vith standard User level privileges
iet.
lhe Password: Test must not be
rccepted by the system. The user
ihould be prompted to enter a
)assword of a minimum length of 6
:haracters.
[he Passwordt Test_Operator
nust be accepted by the system.
Actual ReSult: ge
verify that this user is forced to
change the password. Enter the
stoperator) to login with the
!4eetSSpreified:ne*lt$ !! it!!!/Da!€.Iy
:: :.:::v.t / N^ :::::T6tel : Password: (Lighthouse) and verify
Close and restart the LMS Pharma TestManagerl will be configured
Configura tion Viewstation standard Power llser level
application. Log on as the iviieges seL
administrator user. Create a new
User ID: (TestManager) by copying
the Default Poweruser user
template. Set Password to
[Test_Manager] Verify that the
Group 1 field is set to "Power
Users"; this wjll apply the Power
User group permissions to the new
[TestManager]. Verify that the
Home Page for the user is set to the
faciliry overview display. Click on
the Viewx Tab and make sure this
user does NOT have permission for
any of the items i n the
Create and a new User IDI stAdmin) will be configured
[TestAdmin] by copying the standard Administrator Ievel
Default Administrator user vileges set.
template. Verjfy that the Group 1
field is set to'Administrators"j this
will apply the Administrator group
permissions to the new
(TestAdmin). Set Password to
(Test_Adminl. Verify that the
Home Page for the user is set to the
facility overuiew display. Click on
the Viewx Tab and make sure this
user has permission for all ofthe

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This document may not be reproduced, copied, or distributed without written permission from 47300 Kato Road This document may notbe reproduced, copied, or distribuled withoutwritten permission from
Lighthouse Worldwide Solutions. Fremonl, CA 94538 USA
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 $}R"A$T IT

LICHTHOUSE, oPERATI0NAL (OQ) Page 27 of 72 # LICHTHOUSE oPERATTONAL QUALIFTCATTON (OQ) Page 22 of72
=
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oRrDvirDr. sorttloil5
v,i 805.124 STERILE GEL ffi wof,r.DvlrDr sorsrotts 805.124 STERILE GEL
=q
Ilocument Title: Operational Qualificatron I LWS Document Number: LMS-OR10243-OQ-001 805-124 Document Title: Operational Qualification I LWS Document Number: LMS-OR10243-OQ-001 805,124
Customer: Kotra Pharma IM) Sdn. Bhd, No. 1, 2 & 3, JalanTTC 12, Chene lndustrial Estate, 75250 Melaka, Mala Customer: KotraPharmafM)Sdn-Bhd.No.1.2&3 IalanTTCl2.ChenslndustrialEstatc 7525oMelaka Malawsi:
Proiecl Cleanroom Monitorins Svstem Dater SEP 19.2014 Cleanroom Monitorins Svstem Drtp SEPlq 2O1
LWS Prepared by: Bentreth Goh LWS Department: Seruice LWS Prepared by: Benneth Goh LWS Departmenl Seruice

i.4.1 Securitv Test Table i.4.1 Securitv Test Table

Ftdtbduie Stbh: r ii spgglqqYeijn i 'A-ftal Reaultl. VeriflEd Brt ::::r,,.$ s!fig- - &- .i ii lit{.clrisl Rejulti: VgrjfiCil Ev:
,iflpf t ion ::l Mc.ekjpecit,dRdse!! lllitiiyDate.by : ri !rie.{ tie$ Fel} i..:SlvellIl.tlrlqn MePr:rs,'$::i:*Ef bl,,
ff Sa,,"d...&.iTf !
, ::l:::!t:Ye( / Nd :::: :
: ii.ist
iii ;i:: iMEiShd iri6nt;ihl6 lrts :r:lnlnavDir
r:l: ,:::,: if;ilir

CIose the Configuration
Viewstation, and sta.t the
application again. Make 3
successive login attempls using the
TestAdmin user name buf a n
invalid password. On Ore 4s
attempt, use the correct password.
Verify that the login fails, even
thoush the Dassword is correct.
Create a sample point alarm and
iogin into the Configuration
Viewstation as (Testoperator).
Display the All Alarms page and
verify that (TestOperatorl
aANNnT r.Lh^.,16dd6 ihd.l..-
3. Logged-ln to the Configuration
ViewStation as {Testopeff aorJ
display the Ail Events page and
verify that (TestOperatorl
CAN NOT insed a comment on an
event.
Close the ConFigurarion Viewstatior [TestManager) MUST be able to
and restart the appiication. Login acknowledge the alarm.
as (TestManager); when
prompted, change the password to
(Lighthouse). Verify that
(TestMatragerl CAN acknowledBe
the alarm.
10. Logged-ln to the Configuration
Viewstation as (TestManager)
verify that [TestManager) CAN
insert a comment on an event.
1. Close the Configuration
Viewstation restart the application
Attempt to login as (test_this), and
veriFy that Configu ration
ViewStation access is denied.
12. Close the Configuration
Viewstation restart the application.
Login as [TestAdmin]; when
prompted, change the password to
(Lighthouse). Verify that
Configuration Station access is
After 3 tries the user account will
locked.
[TestOperator] must NOT be able
to acknowledge the alarm.
(TestoperatorJ must NOT be able
to lo8 an event com ment.
TestManager) MUST be able to lo€
Ln event comment.
Vhen attempting to Login to the
lonfiguration Viewstation as
test_this), (an invalid user
Lccount] access to this application
nust be denied.
Vhen attempting to Login to the
lonfiguration Viewstation as
TestAdmin), with the correct
)assword, access to this application
nust be accepted.
b€ 13. Close the Configuration
ViewStation restart the application. rcknowledge the alarm.
Login as ('IestAdmin]. Verify that
(TestAdmin) CAN acknowledge the
alarm.
14. Logged-ln to the Configuration
Viewsta tion as [TestAdminJ, verify
that [TestAdmin) CAN insert
comment on an eyent on the All
EvenLs tab.
15. Rectiti the Unique user ID by
creating new user. Try using the
existins user ID fTestAdminl
16. Password Agjng. Change the
password aging to 1 day for
(TestAdminJ.
17. Auto Log Out. Change user
(TestAdminl to logout after 10
minutes
18. Llser lD barred. Test key in wrong
password for 3 times for user
fTestAdminl
19. Administrator (TestAdminJ will
select different use. to enable and
disable
20. Print Event [,og to ensure the
change test is recorded.
TestAdminl MUST be able to
.TestAdminl
MUST be able to log
ln event comment.
lhe user ID must be unique and
ran't be duplicate
Verify the password need to be
:hange after 1 day. Each user need
:o set password aging. User need to
'e-input new password after the
rassword reach asine limiL
For each log in user ID wili be log
oul automatically after certain
Verify User ID will be barred after
failed login for 3 times.
/erify Administrator will have
tuthority options to control end
tser.
Verify the tests are recorded
accordingly

Liqhtho!se Worldwide Solutions Company CoAfidential Lighthouse Worldwide Solutions Conrpany Confidential
47300 Kalo Road This document may notbe reproduced, copied, or distributed withoutwritten permission from 47300 Kato Road This document may notbe reproduced, copied, or distributed withoutwritten permission from
Fremont. CA 94538 USA Lighthouse Wor ldwide Solutions. Fremont, CA S4538 USA Lighthouse Worldwide Solutions.
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#
Eq
LTCHTHOUSE oPERATTONAL QUALTFTCATToN (OQ) Page 23 of 72 LTGHTHOUSE oPERATToNAL QUATTFTCATTON [OQ) Page 24 of72
lli0RL0w!0 E 50l"I]Il 0il5
Document Titler Operctional Qualificatron
Kotra Pharma fMl Sdn. Bhd, No.
B05.124 STERII,E GEI,

i LWS Document Number: LMS-OR10243-OQ-001 B05-124

=
-t
110ft r.0l|ItDt 50LUTt0il5
Document Title: Operational Qualification
805.124 STERILE GEL

I LWS Document Number: LMS,OR10243-OO-001 805-124

1, 2 & 3, lalan TTC 12, Chens Indusrrial Estate, 75250 Melaka, I Customer: Kotra Pharma lMl Sdn. Bhd. No. 1. 2 & 3. Ialan TTC I 2 Chens Industrial Estatc 752S0 Molak, M.l.
ProiecL Cleanroom Monitorins Svstem Date: SEP 19.2014 Proi-"ct Cleanroom Monitorins S Drre: SEP 19,2014
LWS Prepared by: Benneth Goh LWS Departmentr Service LWS Prepared by: Benneth Goh LWS Departmenti Seruice

6.4,2 System Security Test Comments 6.5 System Floor Plan

Result: _ (passed/ passed with minor
deviation/ failed) Witness Initials: Test Reference: LMS/0Q/3 Run Number;

Test Incident number: Date: Performed by Title:

i;5.1 :SVstefi.Flobr,Plan (Mau and Sensor Locations TeslTelile
:A.d-ttlal:RilSiiltl
Ytiilisg"qy,
lr-sl*lfltlffttlti III:t{o,l:,:.o,1..
1. Startthe Configuration displayed Floor Plan must be a tlue
Viewstation and Login resentation of the actual cleanroom with
with any User level DCP icons correctly located.
accounL Click on the Map
tab to display Kotra LWS 140206-805-124-SP-A
Pharma's Floor Plan map.
Verify the floor plan is a
true representation of the d\+{<..
facility layout for the area.
Click on individual areas
and verify that the Data
Collection Points IDCP]
icons are correctlv located.
2. Verity that the DCP icons ,ach DCP on the map should have a label
have the proper name, and ndicating the sensor name and sensor status.
sensor statlls

47300 Kato Road
Fremont, CA 94538 USA
(51 0) 438-0500 TEL
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This document nray not be reproduced, copjed, or distributed withoul written permission frorn 47300 Kato Road This document may not be reproduced, copied, or distributed without written permission fron)
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(510) 438-0s00 TEL
(510) 438-3840 FAX
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 mm.P"ffiY

# LTCHTHOUSE
w0f, tD'r,t0t 50L0It0Nt
oPERATTONAL QUALTFTCATTON (OQ)
805,124 S]:ERILE CEL
Page 25 of 72 #
ffii
LIGHTHOUSE,
woRtDrgtBs 5sluTloN5
OPERATIONAL QUALIFICATION (OQ)
805.124 STERILE CEL
Page 26 of 72

-il
DocumentTitle: Operational Qualification I LWS Document Number: LMS-OR10243,OQ-001 805-124 Document Title: ODerational Qualjfication I LWS Document Number: LMS-OR10243-OQ-001 B05-124
Customer: Kotra Pharma fM) Sdn. Bhd, No. 1,2 & 3. Ialan TTC 12. Chens lndustrial Estate.75250 Melaka. Malavsia Customer: Kotra Pharma fMl Sdn. Bhd, No. 1, 2 & 3. Ialan TTC 12, Chenq Industrial Estate, 75250 Melaka, Malavsia
Proiect Cleanroom Monitorins Svstem Date: SEP 1g 201 Proiect: Cleanroom Monitoring System Date: SEP 19,2014
LWS Prepared by: Benneth Goh LWS Departmentr SeNice LWS Prepared byi Benneth Coh LWS Department: Seruice

6.5.2 System Floor Plan (Map and Sensor Locations) Test Comments
Result: _ (passed/ passed with minor 6.6 Provide Client PC Access
deviation/ failed) Witness Initials:
Test Reference: LMS/ oQ/4 Run Number:
Test Incident number: Date:
loiilhsnts fincludesiebarure arrd date wiitr vour commentd) ] ,I' .{.ii:" Performed by: TitIE:

t Pro Uerctiehi:.Pc Ac0es$ Tdlt Tt'bleli . i

Sneclfied Result: qerined EVi

t i.t sp"qn*a-iil[e v:*-GIiron'u.*,oa ir hidil/D4te by:
Tester &wiltrEs
From a PC on the network, LMS Pharma Seruer must be able to
launch the LMS Pharma access by a client pC.
Configuration View51211eP and
login to the system. VerifY the
LMS Pharma main seruer can be
aCcess Via another client PLI
To-view ana conauct test f ser able to execute according to
Client PC with regards lo level and privileges which
A\rthorify fuser Level
Operator, power User

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This document may not be reproduced, copied, or distributed without written permission from 47300 Kaio Road 'l his document may
not be reproduced, copied, or distributed without wriften permission from
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# LICHTHOUSE, OPERATIONAL QUALIFICATION (OQ) Page 27 of 72 LrcFrTH0usE oPERATTONAL QUAilFTCATTON (OQ) Page 28 of72
ffi wttf;[DwroE sortiltollt
Qualification
Documetrt Title: Operationai
805.124 STERILE GEL

I LWS Document Number: LMS-OR10243-OQ-001 805-124

Customer: Kotra Pharma fN4l Sdn. Bhd, No. 1,2 & 3, Ialao TTC 12, Chens Industrial Estate.75250 Melaka. Malavsia
=
-il
Yi0f, r.Dl{r 0E 50Luil0t{5
DocumentTitle: OperdLional QuJli[ication
Customer: Kotra Pharma (M) Sdn. Bhd, No. 1, 2 & 3,
BO5-124 STERILE CEL

I LWS DocumentNumber: LN4S-0R10243-OO-001 805-f24

lalan TTC 12, Cheng Industrial Estate,75250 Melaka, Malaysia
Proiect: Cleanroom Monitorine Svstem Date: SEP 19 2014 ProiecL Cieanroom Monitorins SVStem Date: SEP 19.2014
LWS Prepared by: Benneth Goh LWS Department Sewice LWS Prepared by: Benneth Goh LWS Department: Service

6.6.2 Provide Client PC Access Test Comments

Result: _ (passed/ passed with minor 6.7 System Data Collection Redundancy
deviation/ failedJ Witness Initials:

Test Incident number: Date:

TestReference: LMS/OQ/S Run Number:

uf#*fsjifi*t}'ti'dE.s-]cilet\ri W.i+Al#Wff .ffi$.fft*tri,;,7: ,:,,:,1:r1ri:itillllil#.$i#rii$ Performed bv Title:

i,7ri1 : Svstem Data tollectionRddundantv::ifbst llable

Procedufe StCr: : Acttiil:RCSiilti,: refridir BJ{:
M.geB:Speqitrid Rasnlr lp.itjsl/qbhy:
::.:: ,i:::::::Yi< lsd:, : ::
LJ With the system running, connected lhe Back-Up Server failover must
ro the conrrol panel, and collecung )stablish connection to the control
data, remove the network )anel atrd instruments.
connection from the primary LMS
Pharma Seryer. VeriFy the Back-Up
Server establishes communication
with the control panel and stores
.iata lo.2llv
2l Reconnect the LMS Pharma Seryer /Vith the LMS Pharma Seryer back on-
and verify the system is collecting ine and collecting data, the Back-Up
data. Data from the Back-Up Server ;erver mLlst forward it's data up to
will be sent to the LMS Pharma .he Primary Sewer. Data for both
Primary Seruer. )oint should show similarity in any
'eports print for comparison. Data
ost in between switch over should
rot more than 5 samnles-
I Shutdown one ofthe redundarcy Vith the LMS Pharma Server back orr-
server for t hours and restart the ine and collecting data, the Back-Up
shutdown system server. Wait until erver mLrst forward it's data up to
the data finishes synchronize, Than he Primary Server. Data for both
obsewed all data point and compare roint should show similarity in any
the data on bolh seryers. eports print for comparison. Data
,ost in hetueen switch over should
Lot more than 5 samples.

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This document may not be reproduced, copied, or distributed without written permission from 47300 Kaio Road This documert may not be reproduced, copied, or distributed without written permission from
LiehLhou,e Worl,lwide Solulions. FIemont. CA 94538 USA Lrphthouse Worldwide SolutLons.
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 LICHTHOUSE
ty0RtDWl0[ 50LuTt0NI
Document Title: Operatjonal Quaiification
Kotra Pharma fM) Sdn. Bhd No
LWS Prepared by: Benneth Goh
6,7.2 System Data Collection Redundancy Test Comments
Result: _ (passed/ passed with minor
deviation/ failed)
Test Incident number:
47300 Kato Road
Fremont. CA 94538 USA
(51 0) 438-0s00 TEL
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oPERATTONAL QUALTFTCATTON (OQ) Page 29 of72 LICHTHOUSE oPERATToNAL QUALTFTCATTON (OQ) Page 30 of 72
805.124 STERILE CEL
LWS Document Number: LMS-OR10243-OQ-001 805-124
=
ffii woRtDwror 5otunoris
DocumentTitle: Operdtional Qudlrticdtion
805.124 STERII,E CEI,
I LWS DocumentNumber: L\4S-OR10243-OQ-001 B0q-124
1 & 3, lalan TTC 12, Cheng Industrial Estate, 75250 Melaka, Mala Lustomer: KoLra Pharma (Ml Sdn. Bhd, No. 1, 2 & 3, Ialan TTC 12, Chene Industrial Estate.75250 Melaka. Malavsia
Dare: SEP 19.2014 Proiece Cleanroom Monitorine Svstem Date: SEP 1 9. 201 4
LWS Department: Seruice LWS Prepared by: Benneth Goh LWS Department: Service
6.8 Remote Particle Counters
Witness lnitials:
Test Reference: LMS/OQ/6 Run Number:
Date:
Performed by:
mOte Partitle CounterlTes$hE Trble
$piai ned Ra jJ[iti]r*6 spem'ia se*it'a
1) Observe Background Verifi Bti0n Mebod if lppliGble
Counts for Reference
Room Levels should represent true condition of
Instrument and
the installed particle the cleanroom (lS0 Class 5 / Grade A conditionsJ
counter. Verify the after a 5 minute pur-ge period of less than [100)
LMS Pharma system is
0.5-micron particles/fl3 and less than [1J 5.0-
reflecting the true micron particle/ft3 (3,520 0.5-micron particles/m3
particle condition of and iess than 20 5.0-micron particle/m3J or
particLe readings comparable to reference uniL.
the Cleanroom using a
essivc counts lor each Darticle size.
reference uniL The
counts For the remote
particle counter will be
obserued on the LMS
Pharma system.
Make / Model:
LiBhthouse Remote
5 104V
805-1 24-RPC1
2J initiate a high particle High counts are measured for both channels of the
count at installed installed rcmote p.nrcle counter on LMS Pharma.
remote particle
counter by tapping the
sample inleL 805-124,RPC1
3] lnsert a Zero Count After 5 minutes, each counter will report 0
Filter on the installed particles/ft3 in the 0.5 micron and 5.0 micron
remote particle channels.
counter. Verify particle
count drops to zero.
Lighthouse lruoddwide Solutions Company Confidential Liqhthouse Worldwide Solutions Compaily C0nfidential
This document may not be reproduced, copiecl, or distributed without written permission fi om 47300 Kato Road
l his document may not be reproduced, copied, or distributed without written permission ftont
Lighthouse Worldwide Solutions. Fremonl, CA 94538 USA Lighthouse Worldwide Solutions.
(s10) 438-0500 IEL
(510) 438.3840 FAX
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 ffi
:&
LICHTHOUSE
0itD'r,t0t
$i s0l"tlIl0Nl
oPERATT0NAL QUALTFTCATTON (oQ)
B05-124 STERILE GEL
Page 3l of 72 #
Ht
LICHTI-iOUST,
y1
0RL0rr/tDt 501J10ps
oPERATTONAL QUAL!FTCATTON (OQl
B05.124 STERILE GEI,
Page 32 of 72

Document Title: Operational Qualification I LWS Document Number: LMS-OR10243-Oe-001 805-124 Documenl Title: Opemtional QualiFication I LWS Document Number: LMS-OR10243-OQ-001 B05-124
Customer: Kotra Pharma (MJ Sdn. Bhd, No. 1,2 & 3, JalanTTC 12, Cheng Industrial Estate, 75250 Melaka, Malaysia Customer: Kotra Pharma fM) Sdn. Bhd, No. 1,2 & 3, lalan TTC 12, Chene Industrial Estate,75250 Melaka, Malavsia
ProiecL Cleanroom Monitorins Svste Date: SEP 19.2014 Proiect Cieanroom Monitorins Svstem Date: SEP L9.2014
LWS Prepared by: Benneth ooh LWS Department: Seruice LWS Prepared by: Benneth Goh LWS Deparlment: Service

6.8.3 Remote Particle Counter Test Comments

Test Reference: LMS/OQ/6 Run Number:
Result: *-- (passed/ passed with tninor
Performed by: TitIE: deviation/ failed) Witness lnitials:
6.Bi?,Remote Priticle'.CountCr TesrineTable Test Incident number: Date:
PaoaedrlrA Sfeil: SpceifietlResultr Lisr sDecified Re$tr & A&riaLReiult: Yefifiilit Blri
r) Obserue Background Enter'specified i:,:: ItrldaryDate blr
fdaul8 ln ficlds ,,:::i, Tester & lvitness.
Counts for Reference
Room Levels should represent true condition of ;;i;*.:::: , ::::
Instrument and
the cleanroom (lSO Class 5 / Grade B conditionsl
the installed particle
counter. Verify the after a 5 minute purge perjod ofless than [100)
LMS Pharma system o.s-micron particles,/ft3 and less than [1) 5.0-
is reFlecting the true micron particle/ft3 [3,520 0.5 micron particles/m3
particle condition of and less than 20 5.0-micron particle/m3J or
pafticle readings comparable to reference uniL.
the Cleanroom using
Record 3 successive counts for each Dafticle si7e.
a reFerence unit. The :L"e$ #
Refddre Itrffihbflt I SiTp Comt$ Obscfyed
counts for the
S/N: 5 Mi.r
remote particle I
counter will be 5.0 Microns =
obseryed on the LMS 2
Pharma system. Make / Model: 5.0 I
Lighthouse Remote 0 5 Mirr
3
51 04V 50I
Seilsr.:IS Test# :ChannelSize Counts Obser IDitiallDatc
0.5 Mi.rons =
I
5.0 Mi.rons
0.5 Microns
BO5-124-RPC2 2
5.0 Mi.rons
0.5 I
3
5.0 Microns
2J Initiate a high particle lligh counts are measured for both channels ofthe
count at installed installed remote particle counter on LMS Pharma.
remote particlq Siz€ Counts Obmrusd r'lnitial /t)
counter by tapping the 0.5 Microns =
sample inleL 805-124-RPC2
5.0 Microns -
3) lnsert a Zero Count After 5 minutes, each counter will report 0
Filteron the installed particles/ft3 in the 0.5 micron and 5.0 micron
remote particle channels.
counter. Verify particle SdilST ID Test * SlTs ConbKObseruedl Initial/Drta
count drops to zero.
805-124-RPC2 1
5.0 Microns =

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(51 0) 438-0500 TEL
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Liqhthouse lilorldwide Solutaons Company Confidential Lighthouse Worldwide Solutions Company Confidential
This documentmay notbe reproduced, copied, ordistributedwithoutwritten permission fi'om 47300 Kato Road This document may not be reproduced, copied, or distributed wilhout written permission from
Lighthouse !Vorldwide Solutions. Fremonl, CA 94538 USA
Lighlhouse Worldwide Solutions.
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 BHrh r"T
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LICHTHOLJSE oPERATTONAL CATION (OQ) Pags 3) of 72 ffiItOHTHOUSE oPERATTONAL QUATTFTCATTON (OQ) Page 34 of 72

= QUALTFI qtsL
EE w0RrDrttBp E61n1 lcNS 805-124 STERil.E ru ilox10WlBE s0tllTl0llls B05.124 STERII,E GEI,
*TLw.sD;.*rrftr-b",-,Ln"ts'oRl02ia5Q-o0li0;-],4
D*Tftl.,op"rrtt-n"lourli4!1!!L- pocumentlidg; Operational Qualificarion I LWS Documenr Number: LMS-OR10243-OQ-001 B05-124
..;-merKorraphzm;lMls;i.Eq!g:!<&- I"tr" TTC 1r-Ch""- I.d*ktrl Estate, 7s250 !1gl91q. Mrt"r':u-
p-i".r ct"* m 1q qf,ftn.ffilf!9l!.__- Dater sEPiIJ014 'roiect Cle;;dom Monitorins Svstem Date: SEP 1 9. 201 4
LWS Prepared by: Benneth coh LWS DepEft,rent: Sevi6q pWS Prepq1.4 5y: Benneth Goh LWS DeDartment: Seruice

6,9.2 Roorrt Temperature / Relative Humidity Sensor Test Comments

6.9 Room TemPs/ature / Relative Humidity Seq56r Result: (passed/ passed with minor
deviation/ Failed) Witness lnitials:
Test Reference, LMS/oQ/z RUnNumber.
Test lnciderrt number; Date:
Performed by: Title;
-

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*'ied' or distriDuted without written per;issron from 47300 Kato Road This document may not be reproduced, copied, or distributed withoutwritten permission ftom
;fii[:T;;1il,";,i:::;J;:l:o*"0' lremonl, CA g4S3B USA Li gh*rouse Worldwide Solutions.
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 LICHTHOUSE
yli0[tDvlt0E
oPERATT0NAL QUATTFTCATTON (OQ) Page 35 of 72 LICHTHOUSE, oPERATTONAL QUATTFTCATTON (OQ) Page 36 of 72

=
-=
Document
50tljil0t{5
Title: Operational Qualification
B05-124 STERILE GEL

I LWS Document Number; LMS-OR10243-OO-001 B05-124

=
-I
yj0RrDwr0t 50[llil0l,r s
Document Title: OperationalQualification
BO5-124 STERILE GEL

I LWS Document Number: LMS-OR10243-OQ-001 805-124

Customer: Kotra Pharma fMl Sdn. Bhd. No. 1. 2 & 3. Ialan TTC 1 2 Chens Indrrsrrial Estare 7525o Mcl,ka M,le Customer: Kolra Pharma fM) Sdn. Bhd. No. 1.2 & 3, Ialan TTC 12. Chetrs lndustrial Estate.7525O Melaka. Malavsia
Cleanroom Monitorins Svstem Dare: SEP 19,2014 Proiect Cleanroom Monitorins Svstem Date: SEP 19, 2014
LWS Prepared by: Benneth Goh LWS DepartmenL Seryice LWS Prepared by: Benneth Goh LWS DepartmenL Service

6,10.2 Air Velocity Sensor Test Comments

6.10 Air Velocity Sensor Result: _ (passed/ passed with minor
deviation/ failed) Witness Initials:
TestReference: IMS/OQ/8 Run Number:
Testlncidentnumber: Date:
Performed by: Title
ffi*frfifi$.ffi: FlH-tRi #%F+i.1-

,6 r l. 0i [ #ir,,rV, bloEi1iii-:$'s']136i ilrii,liii i:i;i.;+ii=:]t..:N\ttts,1ili.fn{i,llSjff; i-,ji[E#.4*i:r=r.;;.i+i:r:=;?.,i$llLiirll

Prof'eilu: Steii= d& iift r Ir! illi:+\ r_;.\ l,.iN\ i Ildtif,iF.';ftiEo,i4
1) Compare installed tsili-itffi$-*.lp,y.1lli
sensors to a
reference sensor.
Record the time of
the reference
instrument data.
Record data from
Installed units
and reference
unit should be
l
Software ID
ryffi ilffiif,ffiru
lniUal/Date
the sensors in LMS
within +/- 10%
Pharma and print
ofmeasuring
out a report of the
level, based on
data for that time 3
the higher E
period.
precision unit
reading,
805-1.24-AV01

(Note: The time ofthe reference and the collected data in LMS Pharma will not be exactly the same

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Fremont, cA 94538 usA
(510) 438-0500 TEL
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Liqhthouse Worldwide Solutions Company Confident,al Lighthouse Worldwide Soldions Company Confidential
'Ihis document may notbe reproduced, copied, or distributed withoutwritten permission liom 47300 Kato Road This documenl may not be reproduced, copied, or distributed witlout wriftetr permission from
Lrehl-house Worldwide Solutions. Fremonl. CA 94538 USA Li"htl,ouse Worldwide SoluLions.
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(510) 438-3840 FAX
w.oolighihouse-com
l

LTCHTHOUSE oPERATToNAL QUALIFICATIoN (oQ) Page37 of72 LICHTHOUSE oPERATT0NAL qUALTFTCATIoN (OQ) Page 38 of 72
!0tuII0[t
=
-I
lY0fiLDWt0t
Document Title: operational Qualification I lws
B05-124 STERILE GEL

0f,ffiflt number LMs-oR10243-oe-001 B0s-124 =

-I
rij0Rt Dv{t 0t 50[lJTt0il5
Qualification
Document Title: operational
BO5-124 STERtI,E CF,I,

I LWs Document Number: LMS-oR10243-oo-001 805-124

customer: KotraPharma(M)sdn.Bhd,No.1,?&3,JalanTTCl2,chenglndustrialEsrate,T5250Melaka,Malaysia
Proiece Cleanroom Monitoring System I O"t.Sep fS.2Ol Proiece Cleanroom Monitorins SvstFm Date: SEP 19,2014
LWS Prepared by: Benneth Coh I LWS Department: serurce LWS Prepared byr Benneth coh LWS Departmenh Service

6.11.2 Differential Pressure Sensor Test Comments

6.11 Differential Pressure Sensor Result: _ (passed/ passed with minor
deviation/ failed) Witness Initials:
Test Reference: LMS/OQ/9 Run Number:
Test Incident number: Date:
Performed by: Title:

Lighthouse worldwide Solutions company confidential Lighthouse Worldwide Soldions

47300 Kato Road
Fremonl, CA 94538 [.]SA
(510) 438-0s00 TEL
(51 0) 438-3840 FAX
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Company Contidential
Jl: 9*'*:.it T:y.lo!b! t"p'odu."d,
LiBh[house Worldwide Solutions
.opied, or distributed wirhout written permission from 47300 Kaio Road
Fremonl, CA 94538 USA
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(s10) 438-0500 TEL
(510) 438-3840 FAX
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 LICHTHOUSE. OPERATIONAL QUALIFICATION (OQ) Page 39 of 72 LTCHTHOUSI OPERATIONAL QUALIFICATION (OQ) Page 40 of 72

=
# woRr.D'troE sor.t,tn oNs
DocumentTitle:OperationalQualification
B05.124 STERILE GEL

lLWSDocumentNumber:LMS-OR10243-00-001 805-124
=
-a
Y'i0f,tDrtlt0t 50t"lJil0l'l5
Qualification
Document Title: Operational
BO5-124 STERILE GEL

I LWS Document Number: LMS-OR10243-OQ-001 B05-124

Customer: KotraPharmatMlSdn Bhd No 1 2&3 IalanT'IC12 ChenelndustrialEstate 752q0Melaka Mala Customer: Kotra Pharma (Ml Sdn. Bhd, No. 1,2 & 3, Ialan TTC 12, Chene lndustrial Estate.75250 Melaka. Malaysia
Proie.t: ClFanroom Monitorins Svstpm Date: SEP 19, 2014 ProiecL Cleanroom Monitorins Svstem Date: SEP 19.2014
LWS Prepared by: Benneth Coh LWS Departmetrt: Seruice LWS Prepared by: Benneth Goh LWS Depaftment: SeNice

6.12.2 Air Flow Sensor Test Comments

6.12 Air Flow Sensor Result: -- (passed/ passed with minor
deviation/ failed) Witness Initials:
TestReference: LMS/OQ/1O Run Number:
Test Incident number: Date:
Performed by: I rile: lommeuts (include sigrarure and ddte ivitii votit Cqryrfr€i-i #i,,
:t:u uut:t:ut: u:: : : uu: :
SX,ft,t H{E FIA]ij{il$EItY6?; U$tli{Sl#Hft t[ ::::::::::::::t

i4lilr E*dii td* B*t ,.s_i

1i v,$Itifid.aa,*P.,il
1) Compare installed l
temperature ilfi#,f,.88"{}!l,tr

tr*"..] j
sensors to a
reference sensor.
Record the time of
i
lnstalled units
the reference
and reference Software ID Initial/Date
instrument data. unit should be
Record data from Eo
within +/- 10%
the temperature
of measuring
sensors in LMS
level, based on
E2
Pharma and print
the higher
out a report of the precision unit
data for that time 805-124-SMA01
reading.
period.
805-1 24-sMA02

(Note: The time ofthe reference and the collected data in LMS Pharma will not be exactly the same

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47300 Kalo Road This document may not be reproduced, copied, or distributed withoutwritten permission fiom 47300 Kato Road This document may not be reproduced, copied, or distributed wilhoutwriften permission from
Fremont. CA 94538 USA LishU,oure Worldwide Solutions. Fremont, CA 94538 USA Linhtlrouse Worldwide Solutions.
(51 0) 438-0s00 TEL (5r0) 438-0500 TEL
(s10) 438-3840 FAX (510) 438-3840 FAX
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 lgmu-tr'q
LICHTHOUSE oPERATTONAL QUALTFTCATION (OQ) Page 47 of 72 LICHTHOUSE. oPERATTONAL QUALTFtCATTON (OQ) Page 42 of 72

=
ff wo*r.ovtr!t soIuroNs B05-124 STERILE GEL

DocumentTitler operationalQualification I LWS DocumenrNumber: LMS-ORI0243-OO-001 805-124

=
Ef, wontDv,trBt souJnor,r
Document Title: Operational Quaiification
s BO5-124 STERILE GEL

I LWS Document Number: LMS-OR10243-OQ-001 B05-124

Customer: Kotra Pharma [M] Sdn. Bhd, No. 1,2 & 3, Jalan TTC 12, Cheng Industrial Estate,75250 Melaka, Malaysia Customer: Kotra Pharma fMl Sdn. Bhd. No. 1. 2 & 3, Ialan TTC 12, Chenq Industrial Estate.75250 Melaka. Malavsia
ProiecL Cleanroom Monitorins Svstem Date: SEP 19.2014 Paoiect Cleanroom Monitorins Svslem Date: SEP 19.2014
LWS Prepared by: Benneth coh LWS Department: Service LWS Prepared by: Benneth Goh LWS Departmenl Service

Test Reference: LMS/oQ/11 Run Number:

6.13 Viable Samplers Performed by: Tftle:

Test Reference: LMS/0Q/11 Run Number:

Performed by: Title: Prii#odrFp,(ter:
1)
Spgcifl ed RgsUit; ii* sp".ir'"a n*rtav"anoti*,,'.i *r*d '::: ,IeIlfi€GEl&
;iA grr, ialte,S;mplcr,lTe3fifiErfiau-iAll.;.'.t i;'.::, .],r;
With the SMA flow
stopped, verify the
Method lf Appll@bre
- ....
. -:
i , t;.-
$Pitilted:
'ir:kt&r & wi&es
=!trlrlautraf+lbf
i.$'Il+I-,
With the SMA flow off, the Green "System Standby" LED
PiA
Ll
n'6:,1i'i ifi :::{iab,
With the SMA now
SUecifi ed Result: r"t sf elneu n"uri a verifl qrton
,,ajs
.,R6itulb::::
,.
' l;iiial/oat€ ty::::
condition ofthe LED
status lights.
must be ON, and tie BIue "Sampling Active" LED must
be OFF.
ii.,tnql.Isinrli?Ida
i-1,:1, ,;
stopped, verify the Te'ter a tvitEps
:ri_ic.!+eEEsd rs€niior I t) SMA & LEil $ratiisl;
condition of the LED With the SMA flow off, the Green "System Standby" LED ri€ult itr:Ilnld!
must be ON, and the Blue "Sampling Active" LED must :hCloffr ::::::::i- SMA Flow Off
status lights.
be OFF. 805- 124-SMA02 Creen "System Standby"l,ED On
:il sMa & I.ED st;hri ;:::l.CC I:Nd hiHal/,Date Blue "SamDlins Active"l.ED Oft
SMA FIow Off
2) StafttheSMAflowby The SMA flow must START after pressing and holding
B05-124-SMA0 1 Green "Svstem Sbndbv"l.ED on pressing and hold the the "Start Sampling" button, until the Blue "SampJing
Blue "SamplingActive"LED Off "Start Sampling" button Active" LED turn ON. The Green "System Standby" LED ''r
2) StafttheSMAnowby The SMA flow must START after pressing and holding once until "Sampling mrsi hF OFF
Active" LED lights. seEsdi,lD sMA:&:t,Er}lshtuc lnitial /Dane
pressinB and hold the the "Start Sampling" button, until the BIue "Sampling
"Start Sampling" button Active" LED turn ON. The Green "System Standby" LED SMA Flow ON
once until "Sampling must be OFF. 805-124,SMA02 Green "Svstem Standbv"l-ED Off
Active" LED lights. Sen sor::tD:i ,i:r:4,1 L:riSMA & I-EE Sbtus Yd-n:,r Nd
Blue "Sampling Active"LED On
SMA Flow ON
3l With the SMA flow on, The SMA flow must STOP after pressing the "Start
805-124-SMA01 Green "System Standby"LED off stop the SMA flow by Sampling" buttoo. The Green "System Standby" LED
Blue "Sampling Active"LED On pressing and hold the must be ON, and the Blue "Sampling Active" LED must
3) With the SMA flow on, The SMA flow must STOP after pressing the "Start "Start Sampling" button he OFF
stop ttle SMA flow by once until the "System $ensqr IS slilA &rlrED Status I Yedf Nfri::], IroEAl;.ITSIE
Sampling" button. The Green "System Standby" LED
pressing and hold the must be ON, and the Blue "Sampling Active" LED must Standy" t,ED lights. SMA Flow Off
"Start Sampling" button be OFF 805-124-SMA02 Green "System Standby"LED on
once until the "System SCnSoFID lftltidH,,E ate
Blue "Sampling Active"LED Off
Standy" LED lights. SMA Flow Off 4J With the SMA flow The SMA must start and run for t hour, and
805-124-SMA01 Green "System Standby"LED On stopped, Restart the automaticallv stoP. i
"SamplinsActive"LED Off
BIue SMA flow by pressing Ihltial /Datd
4) With the SMA flow The SMA must start and run for L hour, and and Hold the "Start SMA Flow ON
stopped, Restart the automatically stop. Sampling" button.
SMA flow by pressing ii,. ltitirv:Drld Verify the SMA runs for
predefined period of 805-1 24-SMA02
and Hold the "Start Samples for pre-defined period of
SMA Flow ON time and stops
Samplitrg" button. time and Stops
Verify the SMA runs for automatically.
predefined period of B05-1 24-SMAo1
Samples for pre-defined period of
time and stops time and Stops
automatically.

Lighlhouse Worldwide Solutions Compaily Confidentlal Lighthouse Worldwide Solutions Company Conridential
47300 Kato Road This document may notbe reproduced, copied, or distributed without written permission from 47300 Kato Road This document may not be reproduced, copied, or distributed without written permission from
Fremont, CA 94538 USA Lighthouse Worldwide Solutions. Fremont, CA 94538 USA Lighthouse Worldwide Solutions
(510) 438-0500 TEL (51 0) 438-0500 TEL
(510) 438-3840 FAX (510) 438-3840 FAX
ww.goliqhthouse.@m ww.golighthouse.com
=
-t
LICHTHOUSE,
W0ntD'*10t s0t tLTt0Ns
oPERATTONAL QUATTFTCATION (OQ)
B05-124 STERILE GEL
Page 43 of 72 #
€
LICHTHOUSE
y0*tor,lt0t s0LI,Il0fls
OPEMTIONAL QUALIFICATION (OQ)
805"124 STERILE CEL
Page 44 of72

DocumentTiLle:0perational Qualificatjon I LWSDocumentNumber: LMS-OR10243-00-001 805-t24 Document Title: ODerational Oualification I LWS Document Number: LMS-OR10243-00-001 805-'1 24
Customer: Kotra Pharma fMl Sdn Bhd No 1 2 & 3 Ialan TTC 1 2 Cheno Indilstrial Estzte 75250 Melek, M,lav<i, Customer: Kotra Pharma IM) Sdn. Bhd, No. 1, 2 & 3, Ialan TTC 12, Chenq Industrial Estate, 75250 Melaka, Malavsia
Clernroom Monitorins Svstcm Proiece Cleanroom Monitorine Svstem Date: SEP 19. 2014
LWS Prepared by: Benneth Goh LWS Departmentr Service LWS Prepared by: Benneth Goh LWS Departmenti Service

6.13.3 Viable Sampler Test Comments

6.14 Alarm Indicators Test
Result: _ (passed/ passed with minor
deviation/ failed) Witness Initials:
TestReference: FMS/0Q/12 RunNumber:
Test Incident number: Date:
Performed by: Title:
:.-r ,- -7:E - q--:-- :a-:-:a - 1:yt--4. *--:-'w--:@, "/.y " :i
-:-
Note: Due to environmental conditions, it is acceptable and may be necessary to modify the
AlarmondWarninglimitslorthepurposeoftheOQtesting. Resetanychangesbacktothe
original setting upon completion ol the tests.
Use the system Floor Plan or Map lor the following System Alarm Tests.

6;,,14,1r:System*larm Testing,Table., ,.:::::::::::i ; -...----- .- . i

:+.$iu4ra lu
$!tt-$!!{itied te,lglt
1J Create an Alarm High particle The particle counter's State must display
event or set the alarm limits to a'Alarm High" condition on the Data
force an Alarm High alarm Status screen. The particle counter's texl
condition on one particle counter will be red and blink on the Data Status
port for at least 1 sample and window.
verify that an alarm is captured
ih.
^- "-"r--
ll When the Alarm High particle The particle counter's state must change
event condition has cleared, to "Normal" on the Data Status screen.
verify that the particle counter's The particle counter's text will change to
state chaoges to normal but still green but will continue to blink because
shows that the particle counter the alarm is unacknowledged.
has an unacknowledged alarm.
3J Create aWarningHigh particle fhe particle counter's State must display
event or set the alarm limits to | "Warning High" on the Data Sutus
for€e a Warning High condition icreen. The particle counter's text will be
on one manifold system particle /ellow and blink on the Data Status
counter port for at least 1 sample vindow.
and verify that an alarm is

4) When the Warning High particle
event condition has cleared,
verify that the particle counter's
state changes to normal but still
shows that the particle counter
has an unacknowledged alarm.
Liqhthouse Wo.ldwide Solutions Company Confideotial
47300 Kato Road This document may not be reproducerl copied, or distributed without written permission from 47300 Kato Road
fremont, CA 94538 LJSA Lipht],ou.e Worldwide Solutions. Fremont. CA 94538 USA
(510) 438-0500 rEL (51 0) 438-0500 TEL
(s1 0) 43&3840 FAX (s10) 438-3840 FAX
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fhe particle counter's staLe must change
:o "Normal" on the Data Status scaeen.
[he particle counter's text will change to
jreen but will continue to blink because
:he alarm is unacknowledged.
Lighthouse Worldwide Solutions Company Confidential
This document may not be reproduced, copied, or distributed without wriften permission from
Li"hthoure Worldwide Solulions.
 B1
ffiB.Ass

ffi LICHTHOUSE OPERATIONAL QUALIFICATION (OQJ Page 45 of 72 LICHTHOUSE OPERATIONAL QUALIFICATION (OQ) Page 46 of72
Effi woRtDYroE sor.unoNs
DocumentTitler Operational Qualification
BO5-124 STERILE GEL

I LWS Documenr Number: LMS-ORI0243-OO-001 B05,124

=
# wotro,tlBr soLtilo}rs
Document Title: Operational Qualification
B05"124 STERILE GEL

I LWS Document Number: LMS-OR10243-OQ-001 805-124

Customer: Kotra Pharma fMl Sdn. Bhd. No. 1. 2 & 3. Ialan TTC 1 2 Cheno Industrial E(tate 762qo MFl,k, M,l,v<i. Customer: Kotra Pharma fMl Sdn. Bhd. No. 1. 2 & 3. Ialan TTC 12. Chene lndustrial Estate.75250 Melaka. Malavsia
Proiect (;leanroom Monitoring Svste Dare: SEP 19,2014 Proiect Cleanroom Monitorins Svstem Date: SEP 1g 201
LWS Prepared by: Benneth Goh LWS Department: Seruice LWS Prepared by: Benneth Goh LWS Department: Seryice

;:6.l4.L System Alarm Testing Table ' ,, ;.: 6,14,2 Alarm Indicator Test Comments
Acttrrl k**Iti'i
,t** sn*itiBiil *!,,ql 49 Result: _ (passed/ passed with minor
,: . :rYes y' Nilr iiirr.
deviation/ failed) Witness Initials:
i) Log onto the Configuration The sample must chatrge to an
Viewstation as an Administrator acknowledged state and stop blinking.
user and acknowledge the
Test Incident number: Date:
unacknowledged alarm. The
status should remain tie same
lomments finchide,ffifahifte and.drte, noiii Comm"efrt-il S iffil$#%;iffii :ffi'
hut ston hlinkins
5] Create a particle fault evenb The sensor's map icon must display a
condition on one manifold system "Fault" condition [Cyan].
particle counter port for at least 1
sample by restricting Ole inlet
flow ofthe sensor. Vedfy thata
Fault condition is captured on the

) Create high readings on TRH, dP, Viewing display in RED color and Buzze
AV until exceeding High Alarro will be ON and Patlite beacon in REI
and Low Alarm as per stated i! color.
tha Trah.hi.ci^n I icr

) Create Warning Alarm (Higl /iewing display in YELI,OW color anc

Warning and Low Warning) or )atlite beacon in YELLOW. BUzztrR is
TRH, dB AV as per stated in thi )FF in this condition.
Transmission List
9J Create Alarm (less flowl for SMI /iewing Dispiay in RED color for SMA.
during sampling activity.

Witness Signature: Date:

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47300 Kato Road
Fremonl, cA 94538 usA
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Linh,horse worldwide Solutions. Fremont, CA 94538 USA
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 (

L OPERATIONAL QUALIFICATION (OQ) Page 47 of72 LICHTHOUSE oPERATTONAL QUALTFICATToN (OQ)

Y,l0Btr'#t0t 50tuTt0N5 Page 48 of 72

=
B05-124 STERILE GEL
:I l{0n[0i,lt0t 50tljil0ils BO5-124 STERILE GEL
Document Title: operational eualification
I LwsSorummtfrumber: LMS-oR102s:-o0-001 Bo5-12a
Lu:LU"'s'.r\uuailrartrraIrvrrron.bno,No.r,z&3,ralanl't'cl2,chenglndustrialEstate.T5250MelakaMatav<i.
Document Title: operationar Quarification I Lrys Document Numbe., LtutgoRrojJsie:0;i;0r12,
Project: Cleanroom Monitoring System 3, Jaian TTC 12, Cheng Industrial Esrate, 75250 Melaka. Malavsia
Date: SEP 19. 201 Proje€t Cleanroom Monitorine Svstem
LWS Prepared by: Benneth Coh LWS Department: Service LWS Prepared by: Benneth Goh I LWS Department: Seruice

6,15.2 Reports and Trends Test Comments

6.15 Reports and Trends Test Result: (passed/ passed with minor
deviation/ failed) Witness Initials:
Test Reference: LMS/0Q/13
Test Incident number:
Performed by:
-- Date:
Title:

t_$i[::: li$ lEndl tE4ils:=+$-ir=d

&ctual ResUltl
!L ltr [!!if!
$.
.,Restti '1.
,..
Yestno :

1. Log in to the LMS Pharma
Configuration Viewstation as
TestAdmin and click on tie Reports
tab.
. Click on Report tab and change the
Time Range in the Time Range panel
to show data from the previous
hour. Selectone ofthe template
listed under Repoft Tab. Select
"Cenerate New RPnod"
l. Print the report by clicking on the
Print Report icon on the toolbar.
.Export the report by clickiog on the
Export Report button after open on€
report,
Create a new Trend in the Filling
area, Setthe Trend to show the
previous 4 hours of data, and add
traces to the Trend for each channel
in the narticle sFnsor(
7. Click on the Trend underTrend Tat
Witness Signature:
Ihe Reports tab view must be accessible
A report must be created containing da fa
from the selected time frame for all
particle counters. Verify Table, Graph,
Statistics, and Compliance Summary are
displayed and contain data.
Verify the printout displays the report
and matches the report displayed on the
screen.
/erify the report is exported to the
ipecified location, and matches t}le
'eport displayed on the screen.
/erify the new Trend appears in the
:rends list with correct settings and
lata.
y'erify the trew Trend displays, and
:ontains the specified data for the
;Decified time Deriod.
Date:

Liqhthouse Worldwide Soldions Company Confidentia,

47300 Kato Road
Fremont, CA 94538 USA
(510) 438-0500 TEL
(510) 438-3840 FAX
M.golighlhouse.com
This document may notbe reproduced, copied, or distributed without Lighthouse Worldwide Solutions Company Confidential
wriften;ermission from 47300 Kato Road This document may not be reproduced, copied, or distributed without
Lighthouse Worldwide Solutions. Fremont, CA 94538 USA written;ermission from
Ligh&ouse Worldwide Solutions.
(510) 438-0500 TEL
(510) 438-3840 FAX
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#
-il
LTCHTHOUSE
w0RtDYt 0E s0t"lJIt0ilI
Qualificat,on
Document Title: Operational
Customer: Kotra Pharma (M) Sdn. Bhd, No. 1,2 & 3, Ialan TTC 12, Chene Industrial Estate, 75250 Melaka, Malav
Proiect Cleanroom Monitorinp Svstem
LWS Prepared by: Benneth coh
6.16 Calibration Report Test
Test Reference: LMS/oQ/14
Performed by:
il4? Crilihratiod&t
4ffiffiffi{.
1.Pick one sensor and set
Calibration Date from
Confisuration Viewstation
2. Generate CaLibrahon
reporl
3. Verify Calibration Report
on Catibration Date
1. Verify Calibration Report
)n Calibration Due Date
5. Verify Calibration Report
on Days due for Calibration
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oPERATTONAL QUALIFTCATTON (OQ)
B05-124 STERII,E CEI,
Page 49 of 72
=
5
LICHTHOUSE
woft r.D,ttrBE 5or.uTrors
oPERATTONAL QUALTFTCATTON (OQ)
805.124 STERILE GEL
Page 50 of 72
I LWS Document Number: LMS-OR10243-OQ-001 BO5-124 DocumentTitle: Operational oualification I LWS Document Numberi LMS-ORl.0243-00-001 805-124
Customer: Kotra Pharma tM) Sdn. Bhd No -l 2 & 3 Ialan TTC 1 2 Chcno In.tr,.triel F<tatp 7q2qo Mplekz M,l,
Date: SEP 19.2014 Proiecl Cleanroom Monitoring System Datei SEP 19.2014
LWS Department: Service LWS Prepared by: Benneth Goh LWS DepartmenL Service
6.16.1 Calibration Reports and Test Comments
number)
Result: _ ("pass" or Test Incident Witness Initials:
Run Number: Date:
Title:
ittiilii ii :;.]==.=r==...ut, ,=l r;:iili iiiri,i li{
Actqel:ksultr
[.qg!psp.;..!.ff ..-d:1r.ilil!!...............
.::::= Y*:7il.:::ilrlr
.y
lililrirY'P-ii!.elYr
lonfiguration Viewstation should allow user
:o set calibration date and store it with
lalibration Report should generate without
lrror.
lalibraUon Date should match what is input in
itep 1.
jalibration Due date should be 1 year ahead of
ralibration date.
)ays Due for Calibration should be the
rumber of days left before calibration due
iom the date when this report is generated.
;ystem will be generate and determine the
;tatus of sensor calibration.
Lighthouse Woildwide Solutions Company Confidential Lighthouse Worldwide Soldioils CompanV Contidential
This document may notbe reproduced, copied, or distributed withoutwriften permission ftom 47300 Kato Road This document may notbe reproduced, copied, or distributed without written permission from
Lighthouse Worldwide Solutions. Fremonl, CA 94538 USA Lighthouse Worldwide Solutions.
(510) 438-0s00 TEL
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 # LTCHTHOUSE
Yi0Rr.Blvt0t 50tuIt0Ns
oPERATTONAL QUALTFTCATTON (OQl
805.124 STERILE 6EL
Page 57 of 72
:a
LI
$i0il.0wt0t 50tljIt0fl5
r. OPERATIONAL QUALIFICATION (OQ) Page 52 of 72
-il BO5-124 STERILE CEL
Document Title: operational euarification I LWS Document Numbe. t,l.,'slonloz4:-o6r6iios-izi
LusLUrilEr: Norra rnarma IM, 5dn. thd, No. L 2 & 3, Ialan TTC ] 2. chpnp Industrral Esrare,
75250 Meldka, M
Document Title: operationar euarificarion I Lws Doclment Number: LMs-oR1ortoEio1 B0;- 124
LU5LUilrrr; Norra rnarma IMJ )dn. Uhd, No. 1,2 & 3, Jalan TTC 12, Cbeng Industrial
Projece Cleanroomffi r n.ts-. cED ro ,^,, Estate,7S2S0 Melaka, Malaysia
ProjecL Cleanroom Monitorins Svstem Dare: SEP 19,2014
LWS Prepared by: Bennerh coh [LWS O"p**.",":"*" LWS Prepared by: Benneth Goh LWS DepartmenI Service

6.17.1 Cleanroom States Test Comments

6.L7 Cleanroom State Test Result: (passed/ passed with minor
deviation/ failed) Witness Initials:
Test Reference: LMS/0Q/15 Run Number:
Test Incident number: Date;
Performed by: Title:
t igte diton :$Ate.:rlu iiliii::;r$ ..[lffi --

1. Iog into Configuration yerify Cieanroom states can be changed

ueB Sptrifled RefllE
Vk /il; ll EM
,ActudI RCSult:: VCrified Bv:l

Yiewstation and change

:leanroom states
2. Check the pump running Verify pump turn offwhen Cleanroom sEre
;tatus after Cleanroom state enter "Disinfection". Ensure Particle count
:hanges. displayed in Blue color fDisablel.
Verify pump turn ON when the cleanroom
state enter "ln Operation"

/erify pump turn OFF when t}le cleanroom

;tate enter "Maintenance". Ensure particle
:ount displayed in Blue color [Disable].
/erify pump turn ON when the cleanroom
itate enter "At Rest

l. Check the alarm limits for Io verify the alarm Iimits changed according
:hose points been affected :o the spec in transmission Jist (LMS-
)y Cleanroom states
f, R10243-Transmission List-001
:hanges.
iDB 16AUG 2010)

Lighthouse Worldwide Solutions Company Confidenlial

47300 Kato Road
Fremont. CA 94538 USA
(510) 438-0500 TEL
(s10) 438-3840 FAX
M.golighthouse.com
This documentmay not be reproduced, copied, or distributed without written permission itom Lighthouse Worldwide Solutions Company Confidential
47300 Kato Road This document may notbe reproduced, copied, or distributed without written permission from
Lighthouse Worldwide Solutions. Fremont. CA 94538 USA
Lighthouse Worldwide Solutions.
(510) 438-0500 TEL
(s10) 438-3840 FAX
ww_golighthouse.com
 -':-dt
iu*marv
!i
LICHTHOUSE
=
HE wou.owroE sor"tinoNs
DocumentTitle: ODerational Oualification
ustomer: KotraPharma(MlSdn.Bhd,No.1,2&3.lalanTTCl2,ChenelndustriaiEsbte,T5250Melaka,Malaysia
ProiecL Cleanroom Monitorins Svstem
LWS Prepared by: Benneth
6.18 Vacuum Pump Test
Test Reference: LMS/OQ/16
Performed by:
1. Loginto Configuration
Viewstation and View the
Process Tab
l. Press the Pump Condition
)utton to OFF-
3. Pressthe Pump Condition
button to ON.
4. Set the cleanroom state to lhe Pump was turned ON and there were no
'?t Rest", Pump Condition to )ad flow at the Particle Sensor ( l'ault
,ON",
veriry the Particle
counter was NOT showing
"FAULT"
;. Set the Pump Condition
nto "Auto" and the
leanroom state remain at
'At Rest"
i. Set the Pump Condition
nto "Auto" and the
leanroom state change to
'DisinfP.tion"
/. Set the PumpCondition
nto "Auto" and the
leanroom state change to
]. Setthe Pump Condition
nto 'Auto" and the
;leanroom state change to
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tti
OPERATIONAL QUATIFICATION (OQ) Page 53 of72 LICHTHOUST, OPERATIONAL QUALIFICATION (OQ) Page 54 of.72
805.124 STERILE GEL
I LWS DocumentNumber: LMS-OR10243-OO-001 805-124
=
5 voftrD,rtrDE sort,tlons
DocumentTitle: Operational Qualification
BO5-124 STERII-E GEI,
I LWS Document Number: LMS-OR10243-OQ-001 B05-124
Customen Kotra Pharma tMl Sdn. Bhd, No. 1, 2 & 3, Ialan TTC 12. Chene Industrial Estate,75250 Melaka. Malaysia
Date: SEP 19.2014 Proiect Cleanroom Monitorins Svstem Date: SEP 19.2014
Goh LWS Departmene Sewice LWS Prepared by: Benneth Goh LWS DeDartment: Service
9, Setthe Pump Condition The Cleanroom State was set 'At Rest", the
into "OFF" and the pump condition was changed to "Manual OFF"
cleanroom state at "At Resf' and the Pump Status changed to "MANUAL".
The pump was not turning ON even at "At
Run Number: 10. Setthe Pump Condition fhe Cleanroom State was changed to
nto "OFF" and the 'Disinfection", the pump condition was set
:leanroom state change to 'Manual OFF" and the Pump Status changed to
Title: 'Disinfe.tion" Th6 n'l,nn ram.in nEF
the Pump Condition
I 1. Set lhe Cleanroom State changed to "ln
nto "OFF" and the )peration", the pump condition was set to
:4-4ft #d
trsFti;lpi iFrd B.rsJ.!! ,IInrli.SflIEIebv
rleanroom state change to
'ln Operation"
Manual OFF" and the Pump Status changed to
:llri llli,?VkdNdi..ri i ,* :'{a*Ci ll Wlfnds3
MANUAL". The pump was not turning ON
rven at "ln Ooeration" Mode
/erify there is a Pump Conditiotr was setas
Auto" and button for you to press. The pump 12. Set the Pump Condition lhe Cleanroom State changed to
btus must show the vaculrm Dumn is ON. nto "OFF" and the Maintenance", the pump condition was set
)ump Condition changes from AUTO to :leanroom state change to Manual OFF" and the Pump Status changed to
'Maintenance" MANtlAL". The numn remain OFF
4anual OFF and the Pump status changed to
MANUAT," 13. Set the Pump Condition ihe Cleanroom State was set 'At Rest", the
)ump Condition changes from Manual OFF to into "ON" and the cleanroom )ump condition was changed to "Manual ON"
zlanual ON and the Pump stalus remain ;tate at "At Resf' rnd the Pump Status changed to "MANUAL".
'MANUAL" lhe Dumo remain ON
14. Set the Pump Condition [he Cleanroom State was changed to
into "ON" and the cleanroom Disinfection", the pump condition was set
lotrdition).'Ihis is to test the pump was itate change to Manual ON" and the Pump Status changed to
'Disinfection" MANUAL". The pump was notturning oFF
iwitched "ON"
:ven at "Disinfection" Mode
lhe Cleanroom State was set 'At Rest", the 15, Set the Pump Condition lhe Cleanroom State changed to "ln
into "ON" and the cleanroom )peration", the pump condition was set to
)ump condition was changed to "AUTO" and
he Pump Status changed to "ON" itate change to "ln Manual ON" and the Pump SEtus changed to
0peration" MANUAL". The pump remain ON
lhe Cleanroom State was changed to 16. Set the Pump Condition lhe Cleanroom State changed to
'Disinfection", the pump condition was set into "ON" and the cleanroom 'Maintenance", the pump condition was set
'AUTO" and the Pump Status changed to "OFF" state change to 'Manual ON" and the Pump Status changed to
'Maintenance" MANUAL". The pump was not turning OFF
lhe Cleanroom State changed to "ln
)peration", the pump condition was set to
'AUTO" and the Pump Status changed to "ON"
fhe Cleanroom State changed to
'Maintenance", the pump condition was set
'AUTO" and the Pump Status chatrged to "OFF"
Lighthouse Worldwide Soldions Company Conlidential Lighthouse Worldwide Sotutions Company Confidential
This document may not be reproduced, copied, or distributed without written permission from 47300 Kato Road This document may notbe reproduced, copied, or distributed witloutwritten
permission from
Lighthouse Worldwide Solutions. F.emont, CA 94538 USA Lighthouse Worldwide Solutions.
(s10) 438-0s00 TEL
(510) 438-3840 FAX
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I
LICHTHOUSE oPERATTONAL QUALTFTCATTON (OQ) Page 55 of 72 LICHTHOUSE gpERATT6NAL QUATIFICATIoN (oQ) Page 56 of72
=
ffi woRr.D,r/r oE soruTrttNS
Document Title: Operational Qualification
B05-124 STER(LE GEL

I LWS Documenr Number: LMS-OR10243-OQ-001 B05-124

=
Et woRr.owr or soLUiror!
Document Title: Ooerational Oualification lt.W.S fr*nt
s65.124 STERILE 6EL

Number: LMS-OR10243-OQ-001 B05-124

Customer: Kotra Pharma (Ml Sdn. Bhd, No.1,2 & 3, lalan TTC 12, Chens lndustrial Estate,75250 Melaka. Malavsia
ProiecL Cleanroom Monitorinq Svstem Date: SEP 19. 2014 ProiecL Cleanroom Monitorins Svstem Date: SEP 19,2014
LWS Prepared by: Benneth Goh LWS Depa rtment Seruice LWS Prepared by: Benneth Goh LWS Departmenl Service

6.18.1 Vacuum Pump Test Comments

6.19 System Alarms
Result: _ (passed/ passed with minor
deviation/ failedJ Witness Initials: Test Reference: LMS / OQ/ 17 Run Number:

Test Incident number: Date: Title:

Performed by:
i.#, *lii.b rii*I,s- Note: Please refer to the Functional Requiremenls Specification LMS-OR10243-FRS-102 for
the Alarm Condition Color Design;rtion.

'i
6ir r l{rsFite m+lriiii [$ tiilEi+nbki1
:48-tu4l+fi€!ilE
Brirlrni l:Iti@l/ga!S,by:::
,tr{.!,-e-.li
lrlr;t I i $.[X,"illiF
.
ireir, NdiliJ ti: i{e*ior&:ufftes{
1) Create a device communications l'he;;rtkG; u;Gr A la;--m
c oo itidon
failure by disconnecting the nust turn Purple color.
communication cable between a
particle counter and the control
cabinet. Verify the View ClientAll
Events screen shows a device
error after the unit times out
Reconnect the cable between a lhe error status must clear.
particle counter and the control
cabinet. Verify that the error
.onditions arP.lc:rFd
t) Create a High-High particle event the oarticle rcunL".-.! sut" *ust disPlay
or set the alarm limits to force a r 'Aiarm High" condition on the Datd
High-High alarfl condition on ;tatus screen. The Darticle counler's feYl
one particle counter DCP for at vill be red and blin'k on the Da[, Slarus
least 1 sample and veriry thatan vi ndow.
alarm is caDtured on the system
J When the High-High particle the pafticle c"urrt"rk .t"te mst change
event condition has cleared, :o "Normal" on the Data Status screen
verify that the pafticle counter's lhe particle counter's text will change to
state chatrges to normal but still Ireen but will continue to blink because
shows that the particle counter :he alarm is unacknowledged-
has an unacknowledged alarm.

Liqhlhouse Worldwide Solutions Company Confidential Lighthouse worldwide solutions company contidential
47300 Kato Road This document may not be reproduce4 copied, or distributed withoutwritten permission ftom 47300 Kato Road This document may not be reproduced, coPied' or distributed without written permission from
F.emont, CA 94538 USA Lighthouse Worldwide Solutions. Fremonl, CA 94538 USA
(510) 438-0500 TEL Lighthouse Worldwide Solutions.
(510) 438-0s00 TEL
(s10) 438-3840 FAX (510) 438-3840 FAX
w.golighthouse.com ww.goliqhthouse.mm
 MffiAA?T'
#
ffi
LICHTHOUSE
woRr.DwroE sorulttNj
DocumentTitle: Operational Qualification
Customer: KotraPharma(M)Sdn.Bhd,No.1,2&3,JalanTTCl2,ChenglndustrialEstate,TS2SOMelaka,Malaysia
PaolecL Cleanroom Monitorins Svstem
LWS Prepared byi Benneth Goh
6;119;1,Sf.t-.t-Efih1iAlaffi{tis,ff.fili:+*le':il
5) Create a High particle event or
set the alarm limits to force a
High Alarm condition on one
particle counter DCP for at least 1
sample a nd verify lhat an a la rm is
caDtured on tie svstem
iJ When the High particle event
condition has cleared, verify that
the particle counter's state
changes to normal but still shows
that the particle counter has an
unacknowledged alarm,
IJ Log onto the View Client as a
Power User and acknowledge the
unacknowledged alarm. The
status should remain the same
butstoD hlinkins
lJ Create a particle Fault event
condition on one particle counter
DCP for at least 1 sample by
restricting the inlet flow of the
sensor. Verify thata Fault
cotrdition is captured on the
)l Creale a High-High temperature
event or set the alarm limits to
force a High-High alarm
condition on one temperature
DCP for at least 1 sample and
verify that an alarm is captured
on the svstFm
10) When the High-High
temperature eyent condition has
cleared, verify that t}le DCP state
changes to normal but remains
unacknowledged.
111 Create a High temperature event
orset the alarm limits to force a
High Alarm condition on one
temperature DCP for at least 1
sample and verify Lhat an alarm is
captured on the svstem
Liqhthouse Worldwide Solfrions
47300 Kato Road This document may not be reproduced, copied, or distributed without
Fremont, CA 94538 USA Lighthouse Worldwide Solutions.
(51 0) 438-0s00 TEL
(51 0) 438-3840 FAX
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oPERATTONAL QUATTFTCATTON (oQ)
B05-124 STERILE GEL
Page 57 of72 ffi
ffi
LIGHTHOUSE
sorttlors
wosr.outrBE
oPERATTONAL QUALTFICATTON (OQ)
BO5-124 STERILE GEL
Page 58 of72
I LWS Documenr Number: LMS-OR10243-00-001 B0S-124 Qualiricatron I LWS Document Number: LMS-OR10243-OQ-001 B05-124
Document Title: Operational
Customer: Kotra Pharma (M) Sdn. Bhd, N0 1 2 & 3 Iajan TTC 1 2 Chens Industrial Estate 75250 Melaka Mala
Date: SEP 19.2014 Project Cleanroom MonitorinB System Daie: SEP 19,201
LWS Department Service LWS Prepared by: Benneth Goh LWS Department: Seryice
iiill.*l itr-;)i!=............;.........,..* li,:,| 6l9.fSvstematarmTeiiinsfiute ,. i:, :11-:.'+'
v.el-lqr iqi{i,l lr .}leri$
I tnlii.all4-rlr,lry.r,: ,:l$ qFs speqifi!4.:.nqlilt i:::Iriti:l/Dae bf .
l:'6ti!* &.Uitd.ss:: in* ::r:::::::::r. vi! 1 N;:::r:::: ::*;;!l;.:ilri;i
:he particle counter's State must display 121 When the High temperature [he ssn5qa'r rta1. ,ust change to normal
L "High" on the Data Status screen. The event condition has cleared, )ut remain unacknowledged [blinking].
)article counter's text will be red and verify thatthe DCP state changes
)link on the Data Status window. to an normal but remains
I hr.Lh^unpdocd
13) Create a Low temperature event [he sensor's state must display a "Low"
The particle counter's state must change or set the alarm limits to force a )n the Data Status screen. The particle
to "Normal" on the Data Status screen. Low alarm condition on one rounter's text will be yellow and blink on
The particle counter's text will change-to temperature DCP for at least 1 :he Data Status window
green but will continue to blink because sample and verify thdfan alarm is
the alarm is unacknowledged. cap!!r9{9!l!ffy!!9!.
14J When the Low temperature event lhe sensor's state must change to norma
The sample must change to an condition has cleared, verify that )ut remain unacknowledged [blinking).
acknowledged state and stop blinking, the DCP state changes to normal
htrt rFmains rrna.knnwlpdop.i
15] Create a Low-Low temperature lhe sensor's state must display'Alarm
event or set the aiarm limits to ,ow" on the Data Status screen. The
fhe sensor's state must djspiay a 'Tault" force a Low-l,ow Alarm )article counter's text will be yellow and
:ondition. condition on one temperature )link on the Data Status window
DCP for at least 1 sample and
verify that an alarm is captured
on the system.
I 6l When the Low-Low temperature Ihe sensor's state must change to norma
event condition has cleared, )ut remain unacknowledged (blinkingl.
fhe particle counter's state must display verify lhdt the DCP sLate changes
t 'Alarm High" on the Data Status to normal but remains
icreen. The sensor's text will be red and t,n,.Ln^rrroddad
rlink on the Data Status window 17J Log onto the View Clientas a lhe sample must change to an
Power User and acknowledge the rcknowledged state and stop blinklng.
unacknowledged alarm. The
status should remain the same
lhe sensor's state must change to normal but stoD blinkins.
)ut remain unacknowledged (blinking]. 1B) Create a High-High humidity I he sensor's state must display a 'Alarm
event or set the alarm limits to Iigh" on the Data Status screen. The
force a High-High alarm )article counter's text will be red and
condition on one humidity DCP llinh on the Dah Status window
[he sensor's state must display a 'lligh" for at least 1 sample and verify
)tr the Data Status screen. The particle that an alarm is captured on the
:ounteCs text will be red and blink on svstem.
:he Data Status window l9) When the High-High humidity I he sensor's state must change to norma
event condition has cleared, )utremain unacknowledged (blinking).
verify that the DCP state changes
to normal but remains
'rn".knnwlpdopd
Company Confidertia! Company
written permission from 47300 Kalo Road This documenl p6y nol be reproduced, copied, or distributed without wriften permission from
Fremonl. CA 94538 USA
Ligh$ouse Worldwide Solutions.
(510) 438-0500 TEL
(510) 438-3840 FAX
ww.golighthouse.com
 USE
lli0lt0'{t0r 50t"uTt!ils
=f
Document Titlq operatiotral Qualification
Customer: Kotra Pharma (Ml Sdn. Bhd, No. 1, 2 & 3, Ialan TTC 12. Chenp lndustrial Estate. 75250 Melaka. Malavsia
prnipct Cleanroom Monitnrino Sv(tpm
LWS Prepared by: Benneth Goh
t6l[9; $f]S*m *iid,fltrasii1fE,f. -tc.x.i
20J Create a High humidity evenr or
set the alarm limils to force a
High Alarm condition on one
hsmidity DCP for at least l
sample and verify that an alJrm is
captured gn the slstem
1) When the High humidiry event
condition has cleared, verify that
the DCP state changes to normal
hIt remains unacknowledsed
22) Create a Low humidity event or
set the alarm limils to force a Lou
alarm condition on one humidity
DCP for at least 1 sample and
verify that an alaftn is captured
on tJ)e system
23) When the Low humidiq/ event
condition has cleared, verify that
the DCP state changes to normal
but remains unacknowledSed
24J Create a Low-Low humidity
event or set the alarm limits to
force a Low-LowAlarm
I condition on one humidity DCP
for at least 1 sample and verify
thatan alarm is captured on the
251 When the Low-Low humidity
event condition has cleared,
verify that the DCP state changes
to normal but remains
unacktrowledged
26) Logonto the ViewClientas a
Power User and acknowledge the
qnacknowledged alarq. The
status should remain the same
but stop blinking,
27J Create a High-High differential
pressure event or set the alarm
Iimits to force a High-High alarm
condition on one humidity DCP
for atleast 1 sample and verify
that an alarm is cdptured on lhe
houseworldw,de
473ooKato.R-oad-- Tliisdocumentmaynotbereproduced,copied,ordistributedwithoutwrittenpermissionfrom
Fremont. CA 94538 -
USA ,-L.,
,Lishlhouseworldwidesolutions'
i;ilj";&;*ti""^
(510) 438-3840 FAX
ww.qolighthouse-com
oPERATToNAL QUALTFTCATToN (OQ)
B05.124 STERII,E GEI,
I LWS Document Number: LMS-0R10243-oQ,o01 Bo5-124
Date: SFP 1 9. 201 4
LWS
rl,.l ,.,-:= : "
i Verified Bvr
tre4_ri FF.+rtf
:iiiill I YCS{iNd#jl;ri,::ri
Ihe sensor's state must display a'Tligh"
)n the Data Status screen, The particle
:ounter's text will be red and blink on
he Data Status window
[he sensor's state must change to norma
)ut remain unacknowledged (blinkingl.
[he sensor's state must display a "Low"
)n the Data Status screen. The particle
:ounter's text will be yellow and blink on
he Data Status window
fhe sensor's state must change to norma
)ut remain unacknowledged (blinkingJ.
[he sensor's state must display a 'Alarm
,ow" on the Data Status screen. The
)article counter's text will be yellow and
rlink on the Data Status window
lhe sensor's state must change to norma
)ut remain unacknowledged (blinkingJ.
l'he samplemust change to an
rcknowledged state and stop blinking
lhe sensor's state must display a 'AIarm
ligh" on the Data Status screen. The
)article counter's text will be red and
)link on the Data Status window
Solutions
Page 59 of72 LICHTHOUSE 0PERATTONAL QUALTFTCATTON (OQ) Page 60 of72
:- yl0f,t0'#l0t
= 50tl.lil0t.ls
DocumenrTitle: OperdLional Qualificdtion
BO5-124 STERII,E GEI,
I LWS DocumentNumber: L[4S-OR10243-OQ-001 805.124
Customer: Korra Pharma (Ml Sdn. Bhd, No. 1, 2 & 3, Jalan TTC 12, Chene Industrial Estate,75250 Melaka. Malavsia
ProiecL Cieanroom Monitorine Svstem Date: SEP 19. 20'1 4
Department: Service LWS Prepared by: Benneth Goh LWS DepartmenL SeNice
i$ ;iiiirl6rt9-j;t:$ilS- -.!i1-lilarrnitli*ffi#EiT*t4.,'liil, i;..;. .: :r
,ir1:." Soecified Result--- .l
ie{ *3.s.t!!{ 'rIniri.!fi#..atrri'-i+i ;ilt $;;$ *1;51*v.';;-nemg u eurj !,.eet'ryr1,qg,r$.!'+h
2B) When the High-High differential lhe sensor's state must change to normal
pressure event condition has )ut remain unacknowledged (blinking).
cleared, verify that the DCP state
changes to normal but remains
rlni.Lh^$iladdai
29J Create a High differential lhe sensor's state must display a "High"
pressure event or set the alarm )n the Data Status screen. The particle
limits to force a High Alarm :ounter's text will be red and blink orr
condition on one humidity DCP :he Data Status window
for at least 1 sample and verify
that an alarm is captured on the
301 When the High differential lhe sensor's state must change to normal
pressure event condition has )ut remain unacknowledged (biinkingJ.
cleared, verify that fie DCP state
to normal but remains
r)h i.Lh^un-a--i
311 Create a Low differential lhe sensor's state must display a "Low"
pressu re event or set the alarm )n the Data Status screen. I he particle
limits to force a Low alarm :ounter's text will be yellow and blink on
condition on one humidity DCP rhe Data Status window
for at least 1 sample and verity
that an alarm is captured on the
32J When the Low differential lhe sensor's state must change to normal
pressure event condition has )utremajn unacknowledged {blinkingJ.
cleared, verify that the DCP state
changes to normal but remains
Dn".kh^$naddad
33) Create a Low-Low differential lhe sensor's state must display a 'Alarm
pressure event or set the alarm -ow" on t}le Data Status screen. The
Iimits to force a Low-Low Alarm )article counter's text will be yellow and
condition on one humidity DCP )link on the Data Status window
for at least 1 sample and verify
that an alarm is captured on the
4J When the Low-Low differential lhe sensor's state must change to normal
pressure event condition has )ut remain unacknowledged (blinking),
cleared, verify that the DCP state
changes to normal but remains
rrnacknowled ged
Companv Liqhthouse Worldwide Solutions CornpanV Confidential
47300 Kato Road
Fremonl, CA 94538 USA
This document may not be reproduced, copied, or distributed without written permission from
LiehLhorre Worldwide Solulions.
(510) 438-0500 TEL
(s10) 438-3840 FAX
ww.qoliOhthouse.com
 {ff

=
H
LIGHTHOUSE
woRr.otvrot 5otttrotls
oPERATI0NAL QUALTFTCATToN (OQ)
805.124 STERILE GEI,
Page 67 of 72 # LTCHTHOUSI
Y'i0fl[0tl/lBE 50LUIr0ils
OPERATIONAL QUALIFICATION (OQ)
805.124 STERILE GEL
Page 62 of72

ocument Title: ODerational Oualification

-I
D I LWS Il ocu m ent Nu m ber: LMS-OR 1 02 43 -OO-00 1 805- 1 24 DocumentTitlei Operational Qualification I LWS Document Number: LMS-OR10243-OQ-001 B05-124
Customer: Kotra Pharma fMl Sdn. Bhd, No. 1, 2 & 3, Ialan TTC 12, Chens Industrial Estate, 75250 Melaka, tr Customer: Kotra Pharma fMl Sdn. Bhd. No. 1. 2 & 3. lalan TTC 12. Chens lndustrial Estate,75250 Melaka, Malaysia
Proiectr Cleanroom Monitorine Svstem Date: SEP 19.2014 Proiect Cleanroom Monitorins Svstem Date: SEP 19.2014
LWS Prepared by: Benneth Goh LWS Dena rtment Seruice LWS Prepared by: Benneth Goh LWS Department: Seruice

6.19.2 System Alarm Test Comments

q
n
M*Ffi1c'Eildnsslts :r:lnkrluDrtebf= Result: _ (passed/ passed with minor
: rYd:i:Rd,:;:::Si: deviation/ failed) witness Initials:
35) Log onto the View Clientas a The sample must change to an
Power User and acknowledge the acknowledged state and stop blinking
Test Incident number: Date:
unacknowledged alarm. The
status should remain the same

36J Select the Events Tab and Current All ofthe above aiarms created mustbe
Status Tab to verify all alarms are captured in the Current Status tab [while
properly logged. Print both the alarm is active) and the Events Tab
Events and Current S[atu: pages for all historical aiarms.
and attach.
7) Create 2 simultaneous alarms and The system must capture boti alarms in
verify the system will capture the events tab.
both alarms. View the alarms on
the floor plan [facilily map) and The system map will show an alarm
verify the map is in alarm until status until all the alarms are clear.
thF lrst:l:rm.lpers
3Bl Manually enter a calibratiotr date The system must give an alert when the
for one ofthe remote sensors that calibration due date is within a month of
is less than 1. month before the occurring. This alert must be captured in
scheduled calibration due date for the events tab.
that sensor, and verify the system
caDtures the calibration alerL

47300 Kato Road
Fremont, CA 94538 USA
(510) 438-0s00 lEL
(510) 438-s840 FAX
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Lighthouse Worldwide Soluiions Company Confidential Lighthouse Worldwide Soldions Company Confidential
This document may not be reproduced, copied, or distributed without written permissiotr ftom 47300 Kato Road This document may notbe reproduced, copied, or distributed withoutwriften permission fiom
Lighdlouse Worldwide Solulions. Fremont. CA 94538 USA Lighthouse worldwide Solutions.
(51 0) 438-0500 TEL
(s10) 438-3840 FAX
ww.golighthouse.com
# LTCHTHOUSE
Yl0flt0wt0E 50t"uII0ll 5
OPERATIONAL QUATIFICATION (OQ)
BO5-124 STERILE GEL
Page 63 of72 #
*f,
LICHTHOUSE
wof,LD.ttrot 5orurror,r s
OPERATIONAL QUALIFICATION (OQ)
805.124 STERILE GEL
Page 64 of 72

-lE
DocumentTitle: Operational Qualification I LWS Documenr Number: LMS-OR10243-OQ-001 805-124 Document Title: Operational Qualification I LWS Document Number: LMS-OR10243-OQ-001 B05-124
Customer: Kotra Pharma fMl Sdn. Bhd. No. 1. 2 & 3. lalan TTC 12- Chens Industrial Estate.75250 Melaka. Malavsia Customer: Kotra Pharma (Ml Sdn Bhd No. 1 2 & 3. Ialan TTC 12 Ch€ns Industrial Estate 75250 Melaka Malavsia
ProiecL Cleanroom Monitorins Svstem I)ate: SUP 19 2{)14
LWS Prepared by: Benneth Goh LWS Department: Service LWS Prepared by: Benneth Goh LWS Department: Service

6.20 Email Notification Test 6.20.2 Email Notification Test Comments

Result: _ (passed/ passed with minor
Test Reference: tMS/OQ/18 deviation/ failed) Witness Initials:

Performed by: Title: Test Incident number:

i.20.1 Email Notification Test

: Fi6.E"dul Ste*i: A tReai&U
i:l r::::::::::::::::::r,:L':1",i,::
1. Select User '[he user must be exist among the list and have
specified reachable email during the test.

Go to Cotrfiguration ->User -> Select User;

right click properties -> Contact information
tah ->nrrt Fmail -> savo
Select Clean.oom The Cleanroom must be selected among the
cleanroom programmed into the system
accordingly.

Go to Cleanroom selected -> Select Features ->

Select Email Triggering -> Select Email Alarm
-> Select Email; right click properties -> Go to
Email Action Tab -> Select the user -> Select
Email Contact 1 -> Save
3. Select Data Point Ihe data point is selected from APC atrd
Environment sensor. Each sensor is specified
cy a group or individual sensor

30 to sensor point data (data point name);

right click properties -> Go to redirection tab
'> select action -> go to data -> Location of
:leanroom selected -> Sele€t !'eatures -> Selec
Email Triggering -> Email Alarm -> Select

4. Validation lhe end user as per selected wiil receive email

Mhen data alarm is triggered, in this case we
:hoose manually input

lo to data pointj right click -> Select Hand

:ontrol -> input the value above limit -> Select
lK -> lnput administrator password -> Select
lK -> Verified incoming email.

Liqhthouse Worldwide Solutions Company Confidential Liqhthouse Worldwide soldions Companv Contidential
47300 Kalo Road This document may notbe reproduced, copied, or distributed withoutwritten permission from 47300 Kato Road This document may not be reproduced, copied, or distributed without written permission from
Fremont, CA 94538 USA Lighthouse Worldwide Solutions- Fremont, CA 94538 USA Lighthouse Worldwide Solutions.
(sl 0) 438-0s00 TEL (510) 438-0s00 rEL
(51 o) 438-3840 FAX (510) 438-3840 FAX
M.golighthouse.com w.golighihouse.com
 --Fl
lnrmar..u"ur1

=
*I
LICHTHOUSE
wo RtDlrr ot sttr.rJTr o ris
oPERATTONAL QUALTFTCATToN (oQ)
B05.124 STERILE GEL
Page 65 of72 #
:I
LTCHTHOUSE
$0f,t0vlt0t 50rljil0Ns
OPERATIONAL QUALIFICATION (OQ)
BO5-124 SI'ERILE GEL
Page 66 of 72

Document Title: Operational Qualification I LWS Document Number: LMS-OR10243-OQ-001 B05-124 Document Title: Operational Qualification I LWS Document Numberi LMS-OR10243-OQ-001 B05-124
Customer: Kotra Pharma tMl Sdn. Bhd, No. 1,2 & 3. Ialan TTC 12, Chenq Industrial Estate.75250 Melaka, Malaysia Cusiomer: Kotra Pharma fMl Sdn. Bhd. No. 1.2 & 3. Ialan TTC 12. Chenc Industrial Estate ?5250 Melaka. Mala
Proiect Cleanroom Monitorins Svstem Date: SEP 19.2014 Proiecti Cleanroom Monitorins Svste I)atp: SEP 19 2O14
LWS Prepared by: Benneth coh LWS Department Seruice LWS Prepared by: Benneth Goh LWS Departmenl Service

6.21 SPC Test 6.2.1.2 SPC Test Comments

Result: _ (passed/ passed with minor
Test Reference: LMS/0Q/19 deviation/ failed) Witness lnitials:

Per[ormed by: Title: Test Incident number: Date:

lommAnts liniiude-riEiia*tiWe i?ffiitWirr cnrnmeniil .,' ;: t',. ." ;!i4 in;-r
ia$H
!!ril#.lr..ccttt94
jyb+ai.adi: jNn
ii. i{
*ii;.qq ar,:+ttrrIlDri!s:b.ij
l t aa:::a.

l. Select Data Point iPC is a tool to trigger an alarm depending on

Collection rumberoIalarm based on certain numberof
lata point collected. Once the condition .each
:o configured limit, the alarm will turn 0N
rccordingly.

londition of SPC has been set to standard

/alue = 3 out of 5 data collection trisser
Open Graph lraph is use to monitor the data point
:ollection compare to alarm Iimit boarder.

lpen selected base data point collection ->

relert 24 horrrs orenh
Open Grid lrid is use to monitor the triggering from
rormal [Green] to warning [Yellow) to alarm
'Red).

lpen selected base data point collection ->

;elect Grid
Open SPC Grid iPC Crid is uses to monitor counts involved
lase on condition. To proved ttle number of
:ount will trigger the alarm.

lpen selected base data point collection ->

ielect -> Select Data point SPC -> Select
SPC
;PC1 -> Select icons -> Select Grid
Validation Getdata pointto do outofrange value
(Manually using hand control) for 3
consecutive data alarm.

SPCl Grid will how countchange from 1 to 5,

which as result alarm trigger at count of 3 to 5.

After 5 count the SPC will reduce to 0 as long

thara i. n^.^ncd.,ltir,d.l!Fm
^..,!r

47300 Kalo Road
Fremonl, cA 94538 usA
(510) 438-0500 TEL
(s10) 438-3840 FAX
m.golighthouse.com
Lighthouse Worldwide Solutions Company Cootidential Liqhthouse Worldwide Soldions Company Confidential
This document may notbe reproduced, copied, or disftibuted withoutwritten permission from 47300 Kato Road This document may not be rep roduced, copied, or distributed without written permission from
Linh,lrouse worldwide solutions. Fremont, CA 94538 USA Li*hrL.^c Worldwide Sotuuon\.
(5t0) 438-0500 TEL
(510) 438-3840 FAX
M-golighthouse.com
 LICHTHOUSE
=
ffi woBroYrtoE sor"tlTr oN5
Document Title: operational Qualification
Customer: Kotra Pharma (Ml Sdn. Bhd, No. 1.2 & 3. Ialan TTC 12. Chens Industrial Estate 752S0 Metaka Mala
Proiect Cleanroom Monitorins System
LwS Prepared by: Benneth Goh
6.22 GHOST Recovery
Test Reference: LMS/SAT/20
Performed by:
i 6.22.1 GHOST RecoJif} Test
1) ShutdomtheLMS
Phama system overall
and wite doM when the
system is shutdom.
2) Insert the GHOST
cD/UsB key Version
11.5.1.226 and RESTART
the PC
3) Create backup point
using the GHOST CD
with WinPE and store it
into specific location:
4) After PC is restart locate
the image created.
5) Insert the GHOST
CD/USB key Version
11.5.1.226 and RESTARI
the PC
6) Restoretheimagefrom
the stored location olthe
7) After the process is done
resume the LMS Pharma
8) Choose any RPC and
view the data
Lighthouse Worldwide Solut,ons
Road
47300 Kato This document may not be reproduced, copied, or distributed
FJelontrcl-9-aT_9USA LighrhouseWorldwideSolurions.
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oPERATTONAL QUALTFTCATTON (OQ) Page67 of72 LTGHTHOUSE
BO5-124 STERILE GEL
I LWS Documenr Number: LMs-oR10243-oe-001 Bos-124
=
=
w0nlDUr0E 501"uTr0il5
Document Title: Opemtional Qualification
oPERATTONAL QUALTFICATTON (OQ)
BO5-124 STERILE GEL
Page 68
I LWS Documenr Number: LMS-OR10243-Oe-001 805-124
of72
Customer: Kotra Pharma (Ml Sdn. Bhd, No. 1,2 & 3, lalan TTC 12, Chenq Industrial Estate,75250 Melaka, Malavsia
Date: SEP 19,2014 Proiect Cleanroom Monitorins Svste Date: SEP 19.2014
LWS Department: Seryice LWS Prepared by: Benneth Goh LWS Departmenl Service
6.22.2 GHOST Recovery Test Comments
Result: _ (passed/ passed with minor
Run Number: deviation/ failed) Witness Initials:
Title: Test Incident number: Date:
Table , i lH[i '] : i WN,sWll,\Wffi$#E;4.1#4 Wtl:#!6#.W,'ffi
*c*tlte#.E t
:T]'UEIffifitf"!
rerify the system is fully stop and date
,nd time ofsystem shutdown is
ecorded.
)ate md Time system is shutdom:
verify the GHOST CD/USB key version
11.5. 1.225 is inserted.
erify the location of backup to be
:ored.
cca ti on:
/erify the location ofimage
Verify the GHOST CD/USB key version
11.5.1.226 is inserted.
/erify the location of image seiected is
ame
/erify the software is running without
)roblem.
/erify the data recording resuming
lfter the time shutdown was recorded.
Company Confiale0tial Lighthouse Worldwide Solutions Company Contidential
withoutwritten permission Fom 47300 Kato Road This document may notbe reproduced, copied, or distributed without wriften permission ftom
Fremonl cA 94538 usA Li*ht],ouse worldwide soluuons.
(510) 438-0500 TEL
(510) 438-3840 FAX
ltw.golighthouse.com
 mR,srFT Utr

LTCHTHOUSE OPERATIONAL QUALIFICATION (OQJ Page 69 of72 LTCHTHOUSE OPERATIONAL QUALIFICATION (OQ) Page 70 of 72

=
s rY0(t0,,ir0E 50tljil0Ns
DocumentTitle:OperationalQualification
B05-124 STERILE CEL

lLWSDocumeotNumber:LMS-OR10243-00-001805-I24
:rt
= gl 0fttDr,/tDt 50tljlt0il5
DocumetrtTitle: Operational Qualificarion
BO5-124 STERII,E CEI,

I LWS Document Numben LMS-OR10243-OQ-001 805-124

Customer: Kotra Pharma fMl Sdn Bhd No 1 2 & 3 lal,n TTC 1 2 Chpne In.lrrstri"l Est,tp 752q0 Mpl,k, Customel Kotra Pharma tM] Sdn. Bhd, No. 1, 2 & 3, Ialan TTC 12, Chenq Industrial Estate,75250 Melaka, Malaysia
Proiectj Cleanroom Monitorins System Date: SEP 19,2014 Proiect Cleanroom Monitorins Svstem Date: SEP 19.2014
LWS Prepared by: Benneth Goh LWS Department: Service LWS Prepa.ed by: Benneth Goh LWS Department: Seruice

7.O Test Incidents

AllfailedTestsshallberelegatedtothissection. EachTestlncidentshallbedocumentedin
Test Incident Report
a "Test Incident Report " an example of which appears below.
The Tester, Witness, Project Manager, or Customer Representative may determine that a
Review is required as a result of a test incident. A request for a Review shall be indicated in Procedure Title: Incident #r
the "Further Action?" section of the Test Incident Report. Procedure #: Run#: I)ate:
Controlling Tert Referencer
Once the Test Incident has been closed and all parties have agreed on a satisfactory
resolution to the incident, the specific test must be re-performed. The test protocol and Descrit e the Incidentl
results for the test in question must be retained in this section with the original Test
Incident Report. Note that the Test Incident Report may be filled out electronically as long
as original signatures are included. Summarize all Test Incidents in the table below.

All Test Incidents must be fully documented in the table below and resolved prior to
approval ofthe final summary report.
Tester: Date

f.iroiffiil.,tr+1$. =sii*,r={a.=#..'i3bl,.
y,*$ruirid) l'"*- ;1t
Witness:
FutherAction? lYes I I No I
Date:
Date:
Intident# ,,atPiglesed verined By /Date Ifyes, describe the recommended further action:

Proiect Lead: Date:

Could the test Droceed after immediate modifications? Yes No
Does change control need to be implemented? Yes No
Ifyes, specify change request reference:

Test Incident Closed

LWS Proiect Lead: Date:

Customer; Date:

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This document may not be reproduced, copied, or distribubd withoutwritten permission from 47300 Kato Road This document may notbe reproduced, copied, or distributed without wriften permission fuom
L;nhr_t ouse Worldwide Soluhons. Fremonl, CA 94538 USA Linhthouse Worldwide Soluhons.
(s10) 438-0500 TEL
(51 0) 438,3840 FAX
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#
:n
LTGHTHOUSE
lY0fltDvi l0E 50LUIt0ilr
0PERATTONAL QUALTFTCATToN [oQ)
B05-124 STER]LE GEL
Page 71 ofTZ # LTCHTHOUSE
w0fllDl{lBE 50tljIt0ils
OPERATIONAL QUATIFICATION (OQ)
BO5-124 STERILE GEL
Page 72 of72
-t
DocumentTitlei Operational Qualification I LWS Document Number: LMS-OR10243-OQ-001 B05-124 Document Title: Operational oualification I LWS Document Number: LMS-OR10243-OO-001 B05-124
Customer: Kotra Pharma fMl Sdn. Bhd. No. 1.2 & 3. Ialan TTC 12. Chens Industrial Estate. 75250 Melaka. Mala Customer: Kotra Pharma fMl Sdn. Bhd No.1. 2 & 3 Ialan TTC 12 Chens lndustrial Estate 7525o M.l,k, Mel,
ProiecL Cleanroom Monitorine Svstem Date: SEP 19.2014
LWS Prepared by: Benneth Goh LWS Department Seruice LWS Prepared by: Benneth Goh LWS Departrnent: Seruice

8.0 Reviews Review Report

A Review can be held at any time during the testing to formally record any discussions in
relation to specific incidents raised whilst performing the test protocols.
Review #: Reference: I Date:
Reviews may be held at the request of the Tester, Witness, Project Manager, or Customer
Subject:
Representative. Each Review shall be documented in a "Review Report," an example of
which appears below.
&thirirdeas,Namei ll ri :lli f ltliliii.rliirlll,ir:l'li;ii# niilAis?

b"fih'n
Describe the item. incident. etc..

Corrective Action? | Yes I I No I

tfyes, describe the corrective action:

To be completed by, I On or before this date:

Date Completedl

Corrective Action Checked and Approved

Lead:
LWS Proiect I Date:
Customer: I Date:

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Lighthouse Woidwide Solff ions Company Confidential Liqhthouse Worldwide Soldions Companv Confidential
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Liehu,orre Worldwide Soluhons. Fremont CA 94538 USA Linhrhouse Worldwide Solurions.
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