ANNUAL PURIFIED WATER SYSTEM REVIEW REVIEW PERIOD: January December 2021

CONFIDENTIAL

REPORT NO: D8393862 Revision.01

SUBJECT: PURIFIED WATER SYSTEM ANNUAL REVIEW

REVIEW
FROM: 1 January 2021
PERIOD:

TO: 31 December 2021

Jittrapa Kreepoke

AUTHOR:
(Site Hygienist)

AUTHORISED BY:
Vilaichan Padungsupalai

Quality Manager:

Mandy Turgoose

Q.P (if applicable):

CIRCULATION:

QA
TDS

Page 1 of 10
 ANNUAL PURIFIED WATER SYSTEM REVIEW REVIEW PERIOD: January December 2021

1. Change made since the last review

All changes made from the last review during January December 2020 had been completed action
on plan.

The change control that raised in 2021 in this review period are as below. Adding new POU (SPV409)
in subloop Dettol and change source of subloop Dettol from PW2 to PW1 have been implemented.
However, due to low capacity of system. Source of subloop Dettol was changed back to PW2. Adding
new POU in PW2 and PW2 capacity expansion have not been implemented yet in 2021 due to require
long PW shut down plan which highly impact business. So, it is in discussion to cancel and raise new
change control to revise scope.

Type of
Change Date Status of Effectiveness
Change Description
Number raised Change of Change
Control
Sub-Loop Dettol HS Modification by
Purified
25 Mar add 1 POU and change source from Pending
707795 Water N/A
2021 PW2 to PW1 and New 1 POU in SW Change
System/WFI
loop
Purified Pending
25 Mar Add 1 POU at PW 2 supply and 1 POU
707811 Water Assessment N/A
2021 at SW for Serac CIP Skid
System/WFI Team
Purified
PW#2 Capacity Expansion 2.5 to 4.0 Final Impact
755422 5 Aug 2021 Water N/A
m3/hr Analysis
System/WFI
Purified
29 Sep Change PW source of DTT-HS Pending
776065 Water N/A
2021 Subloop from PW1 to PW2 Change
System/WFI

In summary, there is no major change implemented in 2021. Only minor change implemented
and in progress of long term monitoring.

2. System performance

Overall performance of PW1, PW2 and subloop Dettol observed high microbial over alert limit
and over specification. High microbial trend result were captured in deviation and the majority of cause
were contamination at point of use the problem was not from the generation system.
For chemical result which are conductivity and TOC were within trend. Except, subloop Dettol
that during activity of adding point of use, conductivity result were higher than specification then back to
normal trend. During that activity, purified water was not used in the process.
POU TV501, TV508, TV509, TV510 and TV511 from subloop Remegel had been connected to PW1
loop since January 2021 as mentioned in the last annual purified water system review. Performance
Qualification of the system was pass.
In conclusion, overall result pass specification of purified water.

3. Reliability

Purified Water System1 and 2 were operated smoothly without significant breakdown.

Page 2 of 10
 ANNUAL PURIFIED WATER SYSTEM REVIEW REVIEW PERIOD: January December 2021

4. Quality trends

4.1 Microbial count

The quality trends of 2021 are as below

Healthcare loop (PW1)

There were observed microbial result over action limit and out of specification result in TV 301, TV304, TV305, TV306 and TV501 in 2021. Lab
investigation reports and deviations have been raised to capture action of purified water system.

Page 3 of 10
 ANNUAL PURIFIED WATER SYSTEM REVIEW REVIEW PERIOD: January December 2021

Personal care main loop (PW 2)

There were repeat incident of microbial result out of specification at POUA03 in 2021. According to the corrective action to remove POUA03 require PW
system modification thus it need plant shut down plan. POUA03 was not allow to use due to microbial issue. There was overserved microbial result out
of specification cases at POUA02 and POUA04. Lab investigation reports and deviations have been raised to capture action of purified water system.

Page 4 of 10
 ANNUAL PURIFIED WATER SYSTEM REVIEW REVIEW PERIOD: January December 2021

Dettol sub loop

There were observed microbial result out of trend and out of specification in 2021 at TV401, TV402 and TV405. There was microbial result out of trend
from laboratory testing error for one case at TV405. Deviation have been raised to capture action of purified water system.

Page 5 of 10
 ANNUAL PURIFIED WATER SYSTEM REVIEW REVIEW PERIOD: January December 2021

.
4.2 Chemical Results

4.2.1 TOC

All results are within limit in the review period for Purified Water 1, Purified Water 2 and subloop Dettol.

Page 6 of 10
 ANNUAL PURIFIED WATER SYSTEM REVIEW REVIEW PERIOD: January December 2021

4.2.2 Conductivity

There are subloop Dettol modification activity refer EQ2021-025 during 13-26 Apr which cause high conductivity. However, after complete the
modification, conductivity went back to normal in control limit. Another high conductivity incident was on 05 May 21 that was from error of conductivity
sensor. At that time, there were comparison with other conductivity meter and result was in normal range. The incident was raised and captured in QI
QA 033/22

Trend Analysis of Purified Water 2021

5.000
conductivity
PW1

4.000
PW2

DTT-HS sub loop

3.000

Conductivity limit
(<1.3um/cm)
2.000

1.000

0.000

Page 7 of 10
 ANNUAL PURIFIED WATER SYSTEM REVIEW REVIEW PERIOD: January December 2021

5. Deviation and investigation

Recurrent Effectiveness
Date Issued Ref No. Incident Summary Status of deviation
Issue(Y/N) of Deviation
No board control of UV at
28-Jun-21 741379 distribution loop of soft water No Closed - Done N/A
system

Other than out of specification deviations as mentioned in topic 6, there is one minor
deviation related with purified water system raised in 2021. It is that UT found board control
of PW 2 was broken and shut off valve is active. No water supply of PW2. Then the utility
team move board control of distribution loop of soft water to use at PW2 instead. So that no
board control and no UV active at distribution loop of soft water since 23 Jun 2021. Now this
deviation was Closed Done and the effectiveness will be checked in the next internal audit
year 2022.

6. Out-of-specification results obtained during the monitoring;

There were some OOT and OOS in each loop of purified water and deivations have
been raised to do actions as below.

Track wise OOS log Status Effectiveness

Date Issued OOS Description Investigation
Ref. No. No. Deviation of Deviation

OOT phase II - The microbial

Contamination/
results of purified water point
18-Jan-20 556888 M20/002 Micro Close-done N/A
TV302 sampling on 13 Jan 20 were
Contamination
out of trend.

OOS II: water result at Contamination/ N/A

POUA02,TV401 and soft water at Micro Close-done
2/15/2021 693313 M21/011 SPV 102 were out of specification Contamination

OOT &OOS II: Purifed water result Contamination/ CAPA N/A

at TV402 was out of specification Micro Execution
5/28/2021 sampling on 5-6 May 2020 Contamination in Progress
730621 M21/014

OOT and OOS II: water result at Contamination/ CAPA N/A

TV301 andTV305 were out of trend Micro Execution
6/21/2021 738963 M21/023 and out of specification Contamination in Progress

Contamination/ CAPA N/A

OOT II: water result at POUA04 Micro Execution
9/10/2021 769309 M21/025 was out of specification Contamination in Progress

OOT &OOS II: Purifed water result Contamination/ CAPA N/A

at TV402 was out of specification Micro Execution
5/28/2021 730621 M21/030 sampling on 5-6 May 2020 Contamination in Progress

Contamination/
Micro CAPA
OOT II: water result at POUA02 N/A
Contamination Execution
8/25/2021 762817 M21/036 was out of action limit
in Progress

Page 8 of 10
 ANNUAL PURIFIED WATER SYSTEM REVIEW REVIEW PERIOD: January December 2021

Track wise OOS log Status Effectiveness

Date Issued OOS Description Investigation
Ref. No. No. Deviation of Deviation
Contamination/
OOS II: water result at TV306 were Micro Closed- N/A
10/28/2021 785803 M21/047 out of trend and out of specification Contamination done

Contamination/
OOT and OOS II: water result at Micro CAPA N/A
TV301 andTV305 were out of trend Contamination Execution
6/21/2021 738963 M21/048 and out of specification in Progress

Contamination/
DV211202- OOS II: water result at TV402 was Micro Closed- N/A
12/2/2021 008 M21/011 out of specification Contamination approved

7. Setup changes

Type of
Change Effectiveness of
Change Description Status of Change
Number Change
Control
Add 1 POU at PW 2 supply and 1 POU at SW for Pending
707811 Permanent N/A
Serac CIP Skid Assessment Team
Final Impact
755422 Permanent PW#2 Capacity Expansion 2.5 to 4.0 m3/hr N/A
Analysis
Change PW source of DTT-HS Subloop from PW1 to
776065 Permanent Pending Change N/A
PW2

There is three permanent change controls related to water system raised during the period of
review. They are changes of adding point of use, expand the capacity and change source of DTT-HS
subloop. Currently, three of them are in progress as ongoing to complete actions according to plan
for each change. The change controls that are in progress will be captured in next periodic review.

8. Updating of installation documentation;

Validation
Area Reason Responsibility Validtaion Date
Report No.
Engineering &
To add POU Quality
Subloop Dettol EQ2021-025 26-Apr-2021
SPV409

Change Engineering &

Subloop Dettol Source to be Quality EQ2021-075 26-Sep-2021
PW1
Change Engineering &
Subloop Dettol Source to be Quality EQ2021-081 10-Oct-2021
PW2

9. Log books

There are log books used to record the system parameter for both Purified Water System. The
parameters which are recorded for example are pressure, flow, temperature, conductivity, TOC, etc.

The record will be done on daily basis by record once per day to cover 24 hours of system
operation.

Page 9 of 10
 ANNUAL PURIFIED WATER SYSTEM REVIEW REVIEW PERIOD: January December 2021

The records have been reviewed and found to be completed.

10. Situation of the current list of operating procedures.

The list of current SOP regarding Purified Water System is as followed

SOP No. Description Version Effective date

QA115 Process Water Monitoring 41 12 May 2021

ES021 Sanitization for purified water system 19 22 Jun 2021

ES022 Water System Operating Instruction 24 22 Jun 2021

ES023 Water System 7 22 Jun 2021

11. Conclusion and Recommendation

Oveall performance of purified water in 2021 found the microbial trend were increase and repeat
occurrence in some point of use which need to be focused. However, there were actions to do and
completed as plan . Chemical result of purified water were in specification during operation. In conclusion,
purified water system performance were in controlled.

Page 10 of 10