Risk Assessment For Purified Water

More than 2000 document related to pharmaceutical Industry in
Pharmatalks Telegram community👇👇👇👇 t.me/Pharmatalks
FULL RISK ASSESSMENT FOR PURIFIED

WATER GENERATION, STORAGE AND
DISTRIBUTION SYSTEM
S.No. Process Steps/ Risk GMP Risk Justification Other Justification Risk Risk Control (9) Status of RA
(1) Component (3) Yes/No (5) Risk (7) Level (10)
(2) (4) type (6) (8) Mitigation Method (9a) Residual Test
Risk level Docume
(9b) nt
(9c)
PRETREATMENT SYSTEM
1. Bore well
The quality of Yes The final desired No NA High  Ultra filtration Acceptab IQ
the bore water quality will followed by le
water
water is not not be attained. Industrial R.O to be
(Raw good it has considered before
water) high TDS the final RO.
and silica
content.
 MGF shall be
considered in design
to filter & remove
suspended impurities
from bore well water.
 After MGF water

will be transferred to
potable water storage
tank.
 Raw water testing

shall be done before
the design
Risk level Docume
(9b) nt
(9c)
of the system.
2. Bore well
Increased Yes The system shall be Operation Frequent Low  The raw water from Acceptab IQ &
microbial and inefficient to remove al changes of the bore well shall be le OQ
water
particle the increased the RO transferred to a closed
(Raw contaminati microbial and membrane underground raw
water) on of the particulate water storage tank.
infeed raw contamination.
water
 Bore well water

discharge line shall be
provided with the
facility for adding
sodium hypochlorite
solution on line to
raw water.
Water cannot Yes This is required No NA Low Tank bottom shall be Acceptab IQ &
Bore well
be during cleaning of the sloped to a small sump le OQ
water
withdrawn tank or when tank is from where water can be
3.
(Raw completely contaminated pumped out.
water) from the chemically or
storage tank
Risk level Docume
(9b) nt
(9c)
microbiologically.
Tank is directly Yes This may lead to Operation Cleaning of Mediu The tank shall be Acceptab IQ
Bore well
exposed to increased microbial al the tank will m properly closed with lid le
water
4. environment and particulate be difficult.
(Raw contamination
water)
Bore well
Cleaning of Yes After a long period of No NA Low  The tank shall be Acceptab IQ &
the time the microbial provided with man le OQ
water
undergroun d and particulate entry for cleaning in
(Raw storage tank contamination may regular interval.
water) is not be increased and the
possible. system may be
inefficient to remove
 The SOP for
5. cleaning shall be
the increased
prepared and the
microbial and
frequency of the
particulate
cleaning shall be
contamination. established.
Risk level Docume
(9b) nt
(9c)
6. Bore well
Insufficient No The quantity of raw Operation The process Low  The raw water Acceptab IQ &
quantity of water shall not have al may stop due to storage tank shall be le OQ
water
raw water. any impact on the lack of raw sized as per the
(Raw product quality. water. downstream
water) requirements.
 The tank shall be

provide with level
switch for high and
low level to have a
uninterrupted flow.
7. Bore well
Tank wall Yes Unexpected EHS Water may be High  RCC Injection Low IQ
and floor is intrusion of micro- contaminated grouting should be
water
not leak organism by sewage recommended inside
(Raw proof water or the tank.
water) contaminated
 In regular basis tank
by heavy
should be inspected
minerals. for any
cracks.
8. Bore well
Sampling of Yes The bore water No NA High  Sampling point to be Acceptab IQ
the bore well quality shall decide provided for le
water
water is not the final purified sampling of bore
(Raw water
well water.
Risk level Docume
(9b) nt
(9c)
water) possible quality and the

extent of the pre-  Considering the bore
treatment. well water quality
the pretreatment
process shall be
established.
9. Bore well
Overflow of No Over flow water Operation  Spillage of Low The ground water storage Acceptab IQ
raw water in shall not affect the al excess water tank shall be provided le
water
undergroun d product quality requires with level indicator for
(Raw storage tank. frequent high water level in the
water) cleaning of tank.
the area.
 Loss of
resources
i.e. water
10. Bore well

Water yes The water stagnant No NA High  An online sodium Acceptab IQ &
stagnant in will rise the hypochlorite dosing le OQ
water
undergroun d microbial content in in water is
(Raw tank. the water considered in the
water) storage tank with
sampling points.
Risk level Docume
(9b) nt
(9c)
 During validation
sanitization process
and frequency is to be
established. SOP
should be written,
confirmed
and implemented.
 The dosing tank shall

be provided with level
indicator for
Low level of chemical monitoring of high and
Sodium Low chemical will not disinfect the low level of chemical.
11. hypochlori level in Yes water as per the No NA High  Alarm shall be Acceptab IQ &
te level dosing tank requirement provided in case of low le OQ
level of sodium
hypochlorite in
dosing tank.
Risk level Docume
(9b) nt
(9c)
Contaminati
on of the RO The coarse The RO unit
unit particles shall be shall be Multi grade filter shall be
Water with the removed in the RO Operation choked and Acceptab
provided for the filtration
12. filtration coarse No and hence no impact al damaged by the Low le IQ
of coarse particles.
suspended on the product quality coarse particle
particles in
the raw
water.
 Multi grade filter shall

be
dismountable type for
easy removal and
installation.
Multi Choking of the MGF Frequent  Installing of
13. Grade Choking of No shall have no impact Operation removal of Low Pressure indicators at Acceptab IQ &
Filter the MGF on the product quality al the filters the inlet of MGF and le OQ
across the filter to
detect the choke.
 Sampling valve shall be
provide at inlet and
outlet.
 Backwash with
Risk level Docume
(9b) nt
(9c)
high flow rate.

 Operating, Preventive
Maintenance SOP
& Training.
14. Multi Material of No NA Operation Iron and rust Low  The Multigrade Acceptab IQ
Grade construction is al particles may filter MOC to be le
Filter not carry over with well designed.
compatible water and
with water in increases the
long run as the load on the
 Fiber reinforced
plastic (FRP) is
water has down stream
recommended.
chlorine equipment.
content. Life time of
the
equipment
will come
down.
Required Reduction in the  Transfer pump before

Multi
15. water velocity No NA Operation velocity of water Mediu MGF should be of Acceptab IQ
Grade
is al will m suitable le
Filter
not affect in the capacity.
Risk level Docume
(9b) nt
(9c)
available to total output of

pass through the water system.  Installing of
the filter. Backwash with Pressure indicators at
high the inlet of MGF and
flow rate is not across the filter to
possible. detect the water velocity
continuously.
Multi As the No NA Operation The tiny Mediu 10 Micron cartridge Acceptab IQ

Grade porosity of al particle may m filter can be le
Filter the MGF is pass through considered to address
16. high only the and choke the the same in the
coarse R.O downstream.
particle will membrane.
be withhold
Multi Microbial Yes During non No NA Mediu  Filter will be Acceptab IQ &
Grade growth in operation of the m designed to be le OQ
Filter MGF system the water complete drainable
17. hold up will be type to avoid such hold
stagnant and up and installation of
possibility for pressure gauges.
microbial growth.
Risk level Docume
(9b) nt
(9c)
 As the water is
chlorinated the
possibility of
microbial growth is
considerable less.
Reduction in The hardness of the

efficiency of raw water shall be The RO Softener system shall be
the RO unit removed in the RO membrane shall provided for the reducing
Water Operation Acceptab
18. due to hardness No and hence no impact need to be Low the hardness of water. IQ
Softening al le
in on the product quality replaced
the raw frequently.
water.
The hardness of the

Softener shall be
Regeneratio n raw water shall be The efficiency
provided with a brine
of removed in the RO of RO unit
Operation measuring tank and a Acceptab
19. Softener Softener not No and hence no impact would be Low IQ
al regeneration system along le
possible on the product reduced.
with rinsing.
quality.
Risk level Docume
(9b) nt
(9c)
The OBR of the softener

Softener would should be sufficient so as
Softener No effect on the final have
having low quality of water. Operation to allow 8 hours of Acceptab
20. Softener No to be Low OQ
OBR al continuous le
regenerated
frequently. operation.
Whole installation shall

During non be designed as complete
operation of the drainable type to avoid
Microbial system the water hold such hold up and
growth in up will be stagnant Mediu installation of Acceptab IQ &
21. Softener Yes No NA
resin and m pressure Gauges at the le OQ
possibility for inlet & outlet is
microbial growth. recommended.
Mineral
Material of particles may  The Softener MOC to
construction is carry over be well designed.
not Operation
with water and  Fiber reinforced plastic Acceptab
22. Softener compatible No NA al Low le IQ
increase the (FRP) is recommended
with water load on
in long run.
the
Risk level Docume
(9b) nt
(9c)
downstream
equipment.
Life time of the
equipment
will come
down.
The raw
The RO unit Ultra filtration shall be
water has Feed water to RO shall
shall be provided before RO to
23. Filtration high slit Yes have high slit density Operation Hig h Acceptab IQ
al choked and reduce the slit density le
density index
damaged index
index
Increase the  Installing of

Choking of load on the Pressure indicators at
filter may pump and the inlet of the filter and
Ultra- happen due to operational across the filter to detect
delay and IQ,
24. Filtration sludge Yes Effective output Operation High the choke. Acceptab
OQ &
unit. particles in the is not attainable. al there by the  Auto Backwash with le
down stream SOP
raw water. high flow rate at regular
flow intervals.
requirement  Operating, Check
is not
Risk level Docume
(9b) nt
(9c)
achievable. Maintenance SOP

& Training.
 Whole installation shall

be designed ascomplete
drainable type to avoid
During non such hold up and
operation of the installation of pressure
system the water hold Gauges at the inlet &
Ultra- Microbial
up will be stagnant Membrane Mediu outlet is recommended. Acceptab IQ &
25. Filtration growth in Yes Yes
and may clog m  System to be designed le OQ
unit. filters.
possibility for with
microbial growth. sanitization facility.
 Backwashing shall be
done.
Risk level Docume
(9b) nt
(9c)
 Tank to be
designed with
compatible media to
Iron and rust
 Ultra- particles carry
with stand the property
filtered water of the
over
storage tank water. (HDPE/SS304
with water
Water MOC is not Recommended) with
increase the load
collection compatible level switch
on the down
tank (After Operation and sampling Acceptab IQ &
26. . No NA stream Low
Ultra al points. le OQ
 Tank cannot equipment.
filtration) Life time of the  Proper cleaning
be
equipment will method and
cleaned
come interval will be defined
properly.
down. in the SOP.
 Provision for Hot water
sanitization
should be available.
 Not  RO unit is  RO unit shall be

First pass provided. required to provided as a part of pre Acceptab
27. Yes generate process No NA High treatment IQ
RO  Sampling le
water required unit, where water is
after RO is not
for purified separated from
Risk level Docume
(9b) nt
(9c)
possible water generation dissolved salts in

system. solution by filtering
through a semi
permeable membrane.
 Water quality  Sampling point
shall not be shall be provided
checked after RO.
 System should be
 If sufficient designed in such a way
water flow is that the ultra filtered
not water to be collected in
available a UF storage tank with
cavitation of level indicator and
Feed Pump
Water flow the pump controller to give an
for Operation Mediu Acceptab IQ &
28. rate is not No NA takes place. undisturbed continuous
Reverse al m le OQ
sufficient. flow to the R.O. feed
Osmosis  Pump can’t
pump.
deliver the
required  Low pressure
pressure of switch shall be
R.O system. provided at the
Risk level Docume
(9b) nt
(9c)
inlet of RO feed pump.

 Alarm to be provided in
case of low pressure.
 The RO unit shall be

provided with
the provision for
monitoring, indicating
Various and
process controlling the
parameter like conductivity and flow
First pass conductivity Critical GMP rate of water. If the Acceptab IQ &
29. Yes No NA High
RO and flow process parameter output water is not le OQ
rate are not meeting the desired
monitored result the water will
be
drained without
going to the
downstream
system.
Risk level Docume
(9b) nt
(9c)
 Alarm to be provisioned
in case of high
conductivity &
low/ high feed to
RO.
 The R.O shall be hot

water &
chemically sanitizable,
and the system
Possibility of shall be
microbial provide with CIP
Purified water quality IQ,
First pass growth in the system to clean and Acceptab
30. Yes will be affected. No NA High OQ &
RO industrial R.O sanitize the R.O. le
SOP
 SOP for
sanitization and
interval for
sanitization shall be
adopted during
validation.
Risk level Docume
(9b) nt
(9c)
 The dosing unit shall be

provided for sodium
meta bisulfite (SMBS)
The chlorine content
addition to the water
in water shall lead to
SMBS The membrane before RO unit.
oxidation of the RO
dosing not Chlorine membrane and hence Operation shall need to be  The ORP sensor shall Acceptab IQ &
31. provided content is Yes shall affect the final al replaced High be provided for le OQ
before RO high water quality. frequently. monitoring the chlorine
unit content of water with
auto
dump valve.

Low level of chemical be provided with level
Low chemical will not release SMBS indicator for
SMBS level in as per requirement to monitoring of high and Acceptab IQ &
32. level SMBS Yes neutralize No NA High low level of SMBS. le OQ
dosing tank  Alarm to be provisioned
chlorine in water.
in case
of low level.
33. Antiscalan Not No NA Operation Precipitation Low Antiscalant dosing Acceptab IQ

Risk level Docume
(9b) nt
(9c)
t dosing provided al of silica on shall be provided before le

RO RO
membrane can
damage
the
membrane

be provided with level
Low chemical Low level of chemical Precipitation of indicator for
Antiscalan t level in will not release Operation silica on monitoring of high and Acceptab IQ &
34. level antiscalant Yes antiscalant as per al RO High low level of antiscalant le OQ
dosing tank requirement. membrane may  Alarm to be
increase. provisioned in case of
low level.
In high and low As the saturation of the

pH the minerals minerals
pH pH dosing not Recommended pH of in the water will decreases in the neutral
35. correction provided No water not maintained. Operation be in Mediu pH(i.e.) at 7.5 - 8.5, Acceptab IQ
dosing al saturation m a pH le
system form and tends correction dosing
to set system can be provided
to correct
Risk level Docume
(9b) nt
(9c)
over the R.O the pH to required level to

membrane. have a better controlover
filtration.
Low level of chemical  Level sensor shall be

will lead to provided in case of low
pH Low chemical improper level of chemical in pH
correction level in pH maintenance of pH of correction dosing tank. Acceptab IQ &
36. dosing correction Yes the feed water to No NA High  Alarm to be le OQ
chemical dosing tank RO provisioned in case of
level leading to
low level.
decrease in
efficiency of RO.
Wrong Deviation chemical Operating SOP for

37. Chemical Weighing of Yes composition not No NA High weighing the Low SOP
dosing chemicals as requirement chemical
for dosing composition.
FINAL TREATMENT
Risk level Docume
(9b) nt
(9c)
EDI shall be provided

after RO membrane so
as to reduce the
Purified water quality
38. EDI unit Not Provided Yes No NA High conductivity of water so Acceptab IQ
will not be attained.
as to meet regulatory le
standards.
 Water of failed quality

after RO unit shall be
auto dumped through
Water quality
Second Water quality dumping valve.
fails at outlet
39. pass RO of RO-+EDI Yes must meet the No NA High  Water of failed quality Acceptab IQ &
unit unit. specified after EDI shall be le OQ
conductivity. recirculated back to
recovery tank.
The water quality may

The operation be affected by Operation The manual The RO unit shall be fully Acceptab
RO+EDI is not auto
40. unit Yes manual al operation is High automatic and PLC based. le OQ
controlled operation of the RO difficult.
unit due to
Risk level Docume
(9b) nt
(9c)
human errors.
 Various
process  The unit shall be
parameter provided with the
like pH, provision for
 Critical GMP monitoring, indicating
conductivit process parameter.
y, flow and
RO+EDI  Water quality could controlling the, Acceptab IQ &
41. rate, TOC are Yes No NA High
unit not be checked conductivity, TOC and le OQ
not
monitored. flow rate of water.
 Sampling  Sampling point after
point after EDI shall be provided
EDI not
provided
Possibility of  The R.O + EDI Unit

microbial Purified water quality shall be hot water Acceptab IQ,
42. RO + EDI growth in Yes No NA High
will be affected. sanitizable. le OQ &
Unit the R.O +  SOP for SOP
EDI unit sanitization and
Risk level Docume
(9b) nt
(9c)
interval for
sanitization shall be
adopted during
validation.
STORAGE AND DISTRIBUTION OF PURIFIED WATER

 The purified water
generated shall be
stored in a storage tank.
It is difficult for
providing  The purified water from
Storage of No storage of The water quality several user the storage tank shall be
43. purified water purified water No shall not be affected Operation points from Low distributed to the user Acceptab IQ &
before use. if not stored. al points through le OQ
the single
distribution loop and
point of returned back
generation
to PW storage tank
 No water in the  The PW storage tank

Low water
PW The water level shall Operation tank, the Pump shall be provided with Acceptab IQ &
level in the
44. Storage No not affect the water al will run dry. Low level switch for le OQ
storage tank.
Tank quality  It may lead monitoring of low
Risk level Docume
(9b) nt
(9c)
to damage water level.

the pump  PW Distribution pump
and affect should turn off in case of
the process. low level PW in storage
 Manual tank.
observation of  Alarm to be
the water provisioned in case of
level is low level.
difficult
 The Purified water

 Overflow of storage tank shall be
excess water provided with level
requires switch for monitoring
frequent of high water level.
Overflow of
PW Purified water Over flow water shall
cleaning of the  The flow to the tank
area. shall be stopped if tank
45. Storage from No not affect the water Operation Low
Acceptab IQ &
Tank storage tank. quality al  Loss of is full and the water le OQ
resources in shall be recirculated
form of back to UF water
Purified water. storage
tank.
Risk level Docume
(9b) nt
(9c)
in case of low level.
Water stagnant
in Spray balls will be
PW the purified Possibility of Acceptab
considered at the return
46. Storage Yes No NA High IQ
water Microbial growth. flow to create proper le
Tank collection agitation.
tank.
 The storage tank should

be designed as complete
During sanitization drainable type to avoid
of PW tank or hold up.
PW Water could in case  A manual drain valve Acceptab
47. Storage not be Yes of No NA High shall be provided for IQ
le
Tank drained. contamination the draining of the water
water needs to be from the
drained. tank.
Risk level Docume
(9b) nt
(9c)
Temperature indicator
Storage tank Control of Temperature is key cum
Temperatu tank parameter for hot controller shall be
Mediu Acceptab
48. re temperature is Yes water No NA provided for IQ
m le
not monitoring of
sanitization
provided. storage tank
temperature.
Pressure might Storage tank should be

Possibility of be developed provided with
PW Vent filter Acceptab
environmental inside the hydrophobic type of vent
49. Storage not provided Yes Safety High le IQ
contamination of PW. filter with SS
Tank storage tank
housing.
Water droplets  Vent filter should be

may condense and provided with an
remain on the surface electrically heated
of vent filter during housing so as to heat
sanitization of the and maintain the filter
Vent Filter Vent filter is Acceptab IQ &
50. Yes Storage tank, due to No NA High temperature during
not heated. le OQ
difference in sanitization process.
temperatures.  Temperature sensor
May lead to microbial to be installed on
Risk level Docume
(9b) nt
(9c)
contamination. the vent filter housing to

monitor the temperature
of vent filter.
 Filter housing
should be equipped with
ports for integrity test.
 Filter integrity test at
Filter integrity Testing of filter not regular intervals.
IQ,
51. Vent Filter not possible Yes attained , risk of No NA High  Regular exchange of Acceptab
OQ &
contamination filter cartridges le
SOP
(exchange in
controlled area)
 SOP’s: Filter tests;
Maintenance
Affected by Filter efficiency will  High temp.

Vent Filter the high temp. decrease leading to resistant filters Acceptab IQ &
52. Yes No NA High le SOP
during the further should be used.
contamination of  Provision shall be
Risk level Docume
(9b) nt
(9c)
sanitization the PW. incorporated in the SOP

process ”Preventive
maintenance” to
check the
efficiency of the filters.
DISCHARGING OF OUTPUT
 The water
 Water  Water distribution shall be in a
stagnancy in contamination may loop system. The water
the increase shall be in continuous
distributio n due to the bio-load flow in the loop.
line to in the distribution Removal of  All pipelines shall have
different user line to different user stagnant water drainable slope of >
Distributio n points. points. Operation each 1:100. Acceptab
53. Yes High IQ
al time before use  Discharge pump should le
 Sampling point is shall be very b self- draining type.
 No
required to check difficult.  The dead leg in the loop
sampling
water quality in loop shall not be
point
and user points more than 1.5d. (d-
provided.
diameter of the
Risk level Docume
(9b) nt
(9c)
extended part)
 Zero dead leg type
sampling points shall be
provided at return loop
and all
user points.
 Specified flow rate

(>1.2 m/s) will be
maintained in the loop at
return line.
 Flow switch/sensor will
Flow rate in Low flow rate be considered on the
Distributio n the loop is tends to bio-film return line with VFD Acceptab IQ &
54. Yes No NA High
low. formation in the connection to the le OQ
pipe. distribution pump.
 Alarm shall be
generated in case of
flow rate decreased
from 1.2 m/s.
Risk level Docume
(9b) nt
(9c)
Distribution UV purifier shall be

Distributio n loop is not Water Mediu provided in the Acceptab IQ &
55. provided Yes contamination No NA m distribution loop le OQ
with UV may occur with intensity meter for
purifier the UV lamp
 Conductivity sensor
shall be
provided in the
High conductivity
High return linewith
water may
Distributio n conductivity in auto-dumping facility Acceptab IQ &
56. Yes contaminate the fresh No NA High
return line in case of high le OQ
Purified water
conductivity.
 Alarm provision in
case of high
conductivity.
 Online TOC
analyzer to be installed
at return line to tank.
57. Distributio n High TOC Yes Performance No NA High  Provide auto- Acceptable IQ &
failure OQ
dumping valve
coupled with TOC
analyzer.
Risk level Docume
(9b) nt
(9c)
 Alarm provision.
 A suitable
Sanitization process
shall be
provided in the
PLC for effective
sanitization of the PW
storage tank
and distribution
PW system.
Storage tank  Tank should be jacketed
58. Sanitization not Yes Possibility of No NA High and should be plant Acceptab IQ &
& Distributio
possible microbial growth steam supply for heating le OQ
n System
of water during
sanitization.
 Temperature sensor
shall be provided in the
PW storage tank and on
return line to monitor
temperature during
Risk level Docume
(9b) nt
(9c)
sanitization.
 Tank jacket shall be
insulated to prevent loss
of heat during
sanitization.
in case of High/ low
temp.
during sanitization.
Equipment Construction
Internal Surface
 Pre-treatment stage
- all
Internal interconnecting pipes,
surface/ dosing tanks, sampling
contact parts is May lead to the valves shall be Acceptab
59. Surface not compatible Yes water No NA High UPVC or SS 304 and IQ
le
with the contamination the storage tanks
water shall be of HDPE.
 After second pass RO
- Metallic
Risk level Docume
(9b) nt
(9c)
critical contact parts

(piping, PW storage
tank) as well as
instruments, level
sensors, valves etc,
shall be of SS 316 or
better. Pipelines should
be electro polished &
orbitally welded.
 Supporting structure
shall be of SS 304 or
better.
 Diaphragm Valves: SS
316L, electro polished.
 Purified water
distribution
pipeline shall be of SS
316 or better.
Risk level Docume
(9b) nt
(9c)
 Gaskets (shall be high

temperature & pressure
resistant) and O-rings
coming in direct /
indirect contact surfaces
shall be made up of food
grade polymeric
Polymeric materials only and shall
materials are be hat resistant.
Shall lead to
Polymeric not  The easy change of Acceptab
60. Yes water contamination No NA High IQ
materials compatible gaskets must be le
and are not possible.
replaceable  Vendor shall
provide the
certificate for food
grade polymeric
material.
Risk level Docume
(9b) nt
(9c)
Uneven and All welds shall be ground

Weld joints
improperly ground finished to <
Welding not ground Acceptab
weld 1.2 µm Ra and properly
61. Joints properly and Yes No Na High le IQ
joints will form a passivated and orbital
are not
space for dust welding should be done.
passivated
accumulation
May lead to improper

cleaning of the
Internal finish surface which will All internal metallic
62. Finishing is not proper Yes lead to microbial No Na High surface shall be mirror Acceptab IQ
growth hence product polished with le
contamination ≤ 0.5µm Ra
 Suitable gaskets shall

be provided for air tight
Water connection which shall
Joints are contamination be Acceptab
63. Joints Yes may affect the No NA High IQ
leaking replaceable. le
final water
quality.  Quick release
Triclover joints are
Risk level Docume
(9b) nt
(9c)
recommended.
External Surface
Surface is not Supporting structures

May lead to the clean
clean Mediu and Acceptab
64. Surface Yes room No NA IQ
room suitable m frames shall be SS 304. le
contamination
External surface shall be

free from sharp edges,
External finish corners, crevices etc., all
May lead to the Mediu Acceptab
65. Finishing is not proper Yes No NA metallic external surface IQ
microbial growth m le
shall be matt
finished
Risk level Docume
(9b) nt
(9c)
Lubricant shall not enter

Used lubricants in processing zone of
coming in contact of equipment. Any
Lubricant used
the potential product lubricant, if used in the
is not food
contact surfaces may Mediu equipment must be food Acceptab
66. Lubricant grade Yes No NA IQ
lead to the m grade and non- toxic. le
and is toxic in
contamination of the Vendor shall provide the
nature
product certificate
PLC/Control System
 The equipment shall
Process Possibility of human control & detect failure
Process parameters are error leads to a mode automatically.
not Acceptab IQ &
67. automatio n Yes process No Na High  The System shall OQ
controlled which is not validated le
be PLC based and
automaticall y.
fully automatic.
Process / Operating personnel MMI shall be provided

Man- process status must have with Acceptab
68. machine not Yes knowledge No NA High adequate display and le IQ
Interface visible for on the process clean room suitable
operating status key board/Touch
Risk level Docume
(9b) nt
(9c)
personnel. screen for operation.

Display Pre-requisite for The language on the
Man- language not the GMP display of MMI should
69. Yes No NA High Acceptab OQ
machine be English
identified. compliant le
Interface
operation language only.
 Data backup for

process data must be
foreseen
Man- Basis GMP (electronic recording,
machine Recorder requirement 21 CFR part 11 Acceptab IQ/
70. Yes No NA High
Interface failure (incomplete / no compliant). le OQ
documentation)  Diagnostic function test
to be a part of
qualification
activity.
Monitoring/  It should be
recording and possible to
documentati monitor/record GMP
Man-
71. on of GMP Yes Basic GMP No NA High relevant data (e.g. Acceptab OQ
machine
relevant data requirement recorder with le
Interface
not compliance to
possible GAMP 5 / 21 CFR,
Part 11 etc.)
Risk level Docume
(9b) nt
(9c)
 Batch records / print

outs to be defined.
 Printout facility should
be available with fade
proof
prints.
Control
system does Process optimization Failure of set parameters
Control not detect and validation is not gets indicated as alarms Acceptab
72. Yes No NA High OQ
system failures and possible and machine stops. le
generate
alarms
 Operator settings
unchanged and
restored after
PLC / Power May lead to emergency stop / power
Control failure / Process out of some accident failure; Acceptab
73. Yes EHS High OQ
system emergency specification  Alarm message; le
stop  Machine must not start
automatically without
operator
intervention after
Risk level Docume
(9b) nt
(9c)
incident
 SOP for
‘Maintenance and
operation of PW
Generation,
Storage &
Distribution
System’.
 Status parameters
should remain
displayed at each
Process for the process stage.
PLC / Status particular product at  The flow of the process
74. Control parameters Yes particular stage can’t No NA High shall be provided with Acceptab OQ
system not clear be regulated easily. the help of arrows. le
 Alarm should also be
visualized along with
the fault
displayed.
Risk level Docume
(9b) nt
(9c)
 Supplier analysis
(quality management
system for software and
control system
hardware development)
 Input/ Output test
implementation in
Correct function qualification activities
PLC / basic requirement for  The system must
Control Acceptab
75. Malfunction Yes GMP- compliant No NA High contain all OQ
system le
operation necessary protection
devices to
ensure that the
equipment and
article remain in
safe condition.
Parameter
Accessibil settings not Basic GMP Parameters settings Acceptab
76. Yes No NA High should be in numeric OQ
ity to PLC identified requirement le
only.
universally
Risk level Docume
(9b) nt
(9c)
 PLC Clock
Time verification
PLC / measuremen t Process  SOP “calibration Acceptabl e OQ &
77. Control works Yes insufficient No NA High and maintenance” SOP
system incorrect  Time
synchronisation of
system
Minimum 3 level
password protections
should be provided.
No protection  Level 1: for
of PLC operator settable
PLC / against parameters.
78. Control manipulatio n Yes
Basic GMP
No NA High  Level 2: for Acceptab
OQ
system & changes. requirement. editing cycle le
parameters.
 Level 3: for
admin/
engineering level
setting.
Measuring Instruments
Risk level Docume
(9b) nt
(9c)
 Measuring instruments
must have
a suitable
measuring range.
Measuring Measuring  Operational range of
79. instrument s instruments Yes Improper No NA High measuring Acceptab IQ
not suitable measurements instruments > le
instrument working
range.
 They must have
appropriate
accuracy.
 Mounting of
instruments must give
the possibility for
GMP
Measuring Defective instruments dismounting and
relevant
instruments must be dismounted replacement
measuring Acceptab
80. instrument s cannot be Yes for exchange and No NA High  Constructional solution: le IQ
dismounted calibration easy
access for
calibration
activities shall be
given
Risk level Docume
(9b) nt
(9c)
 Measuring instruments
 Instrument s should be calibrated,
not traceable to
Measuring Non calibrated national or
calibrated. international standards.
81. instrument s Yes instruments may lead No NA High Acceptab IQ &
 Re- to false machine  Re-calibration of le OQ
calibration is functions instruments should
not be possible.
possible
System Cleaning and sanitization

 The external
surface shall be smooth
for easy manual
82. Cleaning Cleaning is not Yes Cleaning is basic GMP No NA Mediu cleaning. Acceptab IQ&
possible requirement m  The storage tank and le OQ
distribution system
shall be hot
water sanitizable.
Sanitization of the  First RO shall be

83. Sanitizatio n Sanitization not Yes No NA Low Acceptab IQ &
water system is chemical & Hot Water
possible le OQ
basic process and sanitizable.
Risk level Docume
(9b) nt
(9c)
GMP requirement  The RO shall be hot

water
sanitizable.
 The storage tank and
distribution line shall be
hot water sanitizable.
 Separate CIP
system provision to be
provided for chemical
sanitization.
Cleaning and
sanitization  Cleaning process shall
Cleaning process Possibility of human be performed by a
and parameters are error leads to a automatically
IQ&
84. sanitizatio n not Yes cleaning procedure No NA High controlled system. Acceptab
OQ
automatio n controlled which is not validated  Suitable PLC le
automaticall y control shall be
considered
Risk level Docume
(9b) nt
(9c)
Unique identity no. / flow

direction must be on
components / media,
operator panel, etc. (e.g.
according to P&ID).
Labelling of
components Prerequisite for Labels affixed on the Acceptab
85. Labelling Yes No NA High equipment should be heat IQ
inappropriat e qualification le
resistant.
All labelling in English

language and according
to
project standard.
Maintenance
 Machine shall be
easy to maintain.
Maintenan
Malfunction s
Basic GMP  Preventive maintenance Acceptab IQ &
86. due to worn Yes No NA High procedure should
ce requirement le SOP
parts be available
 The unit must
Risk level Docume
(9b) nt
(9c)
contain necessary
protection devices to
ensure that the
equipment & the
article remain in a safe
condition.
Distribution system
will be
stopped and water  A standby pump
PW Discharge may become Operatio Generation should be provided. IQ &
stagnant leading
87. distributio n Pump No
to decrease in
nal gets Medium  Alarm provision in Acceptable OQ
system failure affected case of pump
temperature and
overload.
hence increase in
bio burden.
System Safety
All electrical
Electrical It will not affect the systems shall be tested for
Electrical systems are not final quality of May lead to Mediu safety and shall be Acceptab
88. No EHS IQ
system verified for water. an accident m provided with safety le
safety markings
e.g. C.E. marking.
Risk level Docume
(9b) nt
(9c)
Heavy noise will The noise liberated by the

Noise level It will not affect the cause problems system shall not be more
89. Noise liberated by the No final quality of water. EHS to the service Mediu than 80 db from 1m from Acceptab OQ
level system is high. persons m the system. le
Emergency stop
function is Emergency stop with
Instantaneo us Does not have any
required for alarm to be installed on
stopping of the impact on quality of
Emergenc y accessible areas on PW IQ &
90. equipment not No EHS equipment, High
stop the product
personnel and generation as well as Acceptable OQ
possible
distribution system.
product
protection
 Compressed air
Improper function of pressure shall be
pneumatic May leads indicative with alarm if
91. Utility Compressed air Yes instruments leads to Operatio improper High low. Acceptab IQ &
Failure is low improper output. nal function of  The total system shall le OQ
the system be shut down
if the compressed air is
low.
Risk level Docume
(9b) nt
(9c)
 Temp. & Pressure limit

for the resistance of the
equipment should be
Does not have any Environment al defined & feeded.
Excess
heating & impact on quality & operator  Elevated temp. & IQ
92. Heating No of the product. EHS safety hazards. Medium pressure should be Acceptable &OQ
Excess
pressure alarmed leading to
the opening of the
safety valve.
Documentation
 All end-users have to be

trained on SOPs
 Training of SOPs has to
Faulty operation be documented
93. User & maintenance Yes SOPs are basic No NA High  Training on the job of Acceptab OQ &
GMP-requirement end users by vendor. le SOP
 Training on
Risk level Docume
(9b) nt
(9c)
operation, setting
parameters, trouble
shooting &
maintenance related
activities.
Operation SOP
does
not contain System operation SOP
94. User proper Yes User may make a No NA High must be reviewed with all Acceptab OQ
information wrong decision. aspects and approved. le
and user
may operate
system
 System should not start

without
Unauthorize d Untrained persons password.
person tries to may damage the  Key-switch should be Acceptab IQ &
95. User start/stop the Yes system or product No NA High provided for system le OQ
system quality may be power up. OR
affected  Physical entry to
equipment room is
Risk level Docume
(9b) nt
(9c)
restricted.
Vendor documentation
shall comprise:
 Material certificates
 Welding
Adequate technical certificates along
documentation is with welder
Technical basic GMP qualification certificate.
Vendor documentati requirement for  Boroscopy reports
96. Yes No NA Mediu Acceptab IQ
Documenta on from qualification and m  Slope Verification le
tion vendor not operation of the report
adequate System  Pressure leak test
report
 Passivation report
 Operating
instruction
S.No. Process Risk GMP Justification Other Justification Risk Risk Control (9) Status of
(1) Steps/ (3) Risk (5) Risk (7) Level RA
Component Yes/No type (8) Mitigation Method Residual Test (10)
(2) (4) (6) (9a) Risk level Docume
(9b) nt
(9c)
 Maintenance
instructions
 Spare part lists
 Drawings
- P&I-diagrams
- Electrical
diagrams
 Functional
desig
n specification
 HMI functions with
screen shot
 List of failure
indications

Risk Assessment For Purified Water

Uploaded by

Copyright:

Available Formats

You might also like

Risk Assessment For Purified Water

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Risk Assessment For Purified Water

Uploaded by

Copyright:

Available Formats

More than 2000 document related to pharmaceutical Industry in

Pharmatalks Telegram community👇👇👇👇 t.me/Pharmatalks

FULL RISK ASSESSMENT FOR PURIFIED

 After MGF water

 Raw water testing

 Bore well water

 The tank shall be

water) possible quality and the

10. Bore well

 The dosing tank shall

 Multi grade filter shall

high flow rate.

Required Reduction in the  Transfer pump before

available to total output of

Multi As the No NA Operation The tiny Mediu 10 Micron cartridge Acceptab IQ

Reduction in The hardness of the

The hardness of the

The OBR of the softener

Whole installation shall

Increase the  Installing of

achievable. Maintenance SOP

 Whole installation shall

 Not  RO unit is  RO unit shall be

possible water generation dissolved salts in

inlet of RO feed pump.

 The RO unit shall be

 The R.O shall be hot

 The dosing unit shall be

 The dosing tank shall

33. Antiscalan Not No NA Operation Precipitation Low Antiscalant dosing Acceptab IQ

t dosing provided al of silica on shall be provided before le

 The dosing tank shall

In high and low As the saturation of the

over the R.O the pH to required level to

Low level of chemical  Level sensor shall be

Wrong Deviation chemical Operating SOP for

EDI shall be provided

 Water of failed quality

The water quality may

Possibility of  The R.O + EDI Unit

STORAGE AND DISTRIBUTION OF PURIFIED WATER

 No water in the  The PW storage tank

to damage water level.

 The Purified water

 The storage tank should

Pressure might Storage tank should be

Water droplets  Vent filter should be

contamination. the vent filter housing to

Affected by Filter efficiency will  High temp.

sanitization the PW. incorporated in the SOP

 Specified flow rate

Distribution UV purifier shall be

critical contact parts

 Gaskets (shall be high

Uneven and All welds shall be ground

May lead to improper

 Suitable gaskets shall