PHARMA DEVILS

QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN FOR PURIFIED WATER PRE-TREATMENT, GENERATION, STORAGE &
& DISTRIBUTION SYSTEM

Risk GMP Justification Justification Risk Level Risk Control

S.No. Process Other Risk
Risk Residual risk Verification
Steps/Component type Mitigation Method
Yes/No level
PRETREATMENT SYSTEM
A. Process
A.1. Raw Water Tank
1. Bore well water Increased Yes The system shall be Operational Frequent Low Acceptable IQ/OQ
(Raw water) microbial and inefficient to changes of the The raw water from the
particle remove the RO membrane bore well shall be
contaminatio increased microbial transferred to a closed
n of the in- and particulate underground storage
feed raw contamination. tank.
water The transfer piping shall
be provided with the
facility for adding
sodium hypochlorite
solution on line to raw
water.
2. Bore well water Water cannot Yes This is required No NA Low Acceptable IQ/OQ
(Raw water) be withdrawn Tank bottom shall be
during cleaning of sloped to a small sump
completely the tank or when
from the from where water can be
tank is contaminated pumped out.
storage tank chemically or
microbiologically

3. Tank is Yes This may lead to Operational Cleaning of the Medium Acceptable IQ
Bore well water The tank shall be
directly increased microbial tank will be
(Raw water) difficult. properly closed with lid
exposed to and particulate
environment contamination
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN FOR PURIFIED WATER PRE-TREATMENT, GENERATION, STORAGE &
& DISTRIBUTION SYSTEM

Risk GMP Justification Justification Risk Level Risk Control

S.No. Process Other Risk
Risk Residual risk Verification
Steps/Component type Mitigation Method
Yes/No level
PRETREATMENT SYSTEM
4. Bore well water After a long period The tank shall be
(Raw water) Cleaning of Yes of time the No NA Low provided with man entry Acceptable IQ/OQ
the under microbial and for cleaning in regular
ground particulate interval.
storage tank contamination may
is not be increased and the The SOP for cleaning
possible. system may be shall be prepared and the
inefficient to frequency of the cleaning
remove the shall be established.
increased microbial
and
particulate
contamination.
5. The raw water storage
The quantity of raw tank shall be sized as per
water shall not have the downstream
The process
Bore well water Insufficient any impact on the requirements.
may stop due to
quantity of No product quality Operational Low The tank shall be Acceptable IQ/OQ
(Raw water) lack of raw
raw water provided with level
water.
indicator for high and
low level to have a
uninterrupted flow.
6. Tank should have
suitable construction of
Water may be
RCC with Epoxy
Bore well water Tank wall Unexpected intrusion contaminated
coating/Tiles is
and floor is Yes of micro- organism EHS by sewage High Low IQ
(Raw water) recommended.
not leak proof water or
contaminated
In regular basis tank
by heavy
should be inspected for
minerals.
any crack
A.2. Processing and Process Controls
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN FOR PURIFIED WATER PRE-TREATMENT, GENERATION, STORAGE &
& DISTRIBUTION SYSTEM

Risk GMP Justification Justification Risk Level Risk Control

S. Process Other Risk
Risk Residual risk Verification
No. steps/component type Mitigation Method
Yes/No level
7. SOP for raw water
The bore water
sampling shall be
quality shall
Sampling of prepared.
decide the final
the bore well
Bore Well Water Yes purified water No NA High Acceptable IQ/OQ
water is not Considering the borewell
quality and the
possible water quality the
extent of the
pretreatment process shall
pretreatment.
be established.
8. Spillage of
The ground water storage
Overflow of excess
Over flow water tank shall be provided
raw water in wate
Raw Water No shall not affect the Operational Low with level indicator for Acceptable IQ
under ground r requires
product quality high water level in the
storage tank. frequent
tank.
cleaning of
the
area
9. An online sodium
hypochlorite dosing in
water is considered with
Water The water stagnant sampling points.
stagnant in will rise the During validation
Raw Water yes No NA High Acceptable IQ& OQ.
under ground microbial content sanitization process and
tank. in the water frequency is to be
established. SOP should
be written, confirmed and
implemented.
Low level of Level sensor shall be
Low chemical
chemical will not provided in case of low
10. Chlorine level level in dosing Yes No NA High Acceptable IQ
disinfect as per the level of chlorine in
tank
requirement dosing tank.
Contamination
The coarse
of the RO unit The RO unit
particles shall be
with the shall be Multi grade filter shall be
removed in the RO
11. Water filtration coarse No Operational chocked and Low provided for the filtration Acceptable IQ
and hence no
suspended damaged by the of coarse particles.
impact on the
particles in the coars
product quality
raw water. e particle
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN FOR PURIFIED WATER PRE-TREATMENT, GENERATION, STORAGE &
& DISTRIBUTION SYSTEM

Risk GMP Justification Justification Risk Level Risk Control

S. Process Other Risk
Risk Residual risk Verification
No. steps/component type Mitigation Method
Yes/No level
Multi grade filter shall be
dismantle type for easy
removal and installation.
-Installing of Pressure
Gauge at the inlet of
MGF and across the filter
Choking of the
Frequent to detect the chock.
Choking of the filter shall have
12. Multi Grade Filter No Operational removal of the Low - Sampling Point shall be Acceptable IQ/OQ
filters no impact on the
filters provided at inlet and
product quality
outlet.
- Backwash with high
flow rate.
- Operating, Preventive
Maintenance SOP &
Training.
Iron and rust
particles may
Material of
carry over with
construction is
water and The Multi-grade filter
not compatible
increases the MOC to be well
with water in
13. Multi Grade Filter No NA Operational load on the Low designed, Rubber lined Acceptable IQ
long run as the
downstream mild steel is
water has
equipment. Life recommended
chlorine
time of the
content.
equipment will
come down.
Reduction in the
velocity of
Required Installing of Pressure
water will affect
water velocity Gauge at the inlet of
in the total
is not MGF and across the filter
14. Multi Grade Filter No NA Operational output of the Medium Acceptable IQ
available to to detect the water
water system.
pass through velocity continuously.
Backwash with
the filter.
high flow rate is
not possible.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN FOR PURIFIED WATER PRE-TREATMENT, GENERATION, STORAGE &
& DISTRIBUTION SYSTEM

Risk GMP Justification Justification Risk Level Risk Control

S. Process Other Risk
Risk Residual risk Verification
No. steps/component type Mitigation Method
Yes/No level
As the
porosity of the The tiny particle
MGF is high may pass Micron filter can be
15. Multi Grade Filter only the No NA Operational through and Medium considered to address the Acceptable IQ
coarse particle chock the R.O same.
will be membrane.
withhold
-Whole installation shall
be designed as complete
During non
drainable type to avoid
operation of the
such hold up and
Microbial system the water
installation of pressure
16. Multi Grade Filter growth in Yes hold up will be No NA Medium Acceptable IQ & OQ
Gauges.
filters. stagnant and
- As the water is
possibility for
chlorinated the
microbial growth.
possibility of microbial
grow this
considerable less.
The dosing unit shall be
The chlorine provided for sodium
content in water meta-bi-sulfite (SMBS)
shall lead to The membrane addition to the water.
Chlorine oxidation of the shall need to be
17. SMBS Yes Operational High Acceptable IQ/OQ
content is high RO membrane replaced The ORP sensor shall be
and hence shall frequently. provided for monitoring
affect the final the chlorine content of
water quality. water with auto dump
valve.
Precipitation of
Does not have
silica on RO
impact on output Anti-scalant dosing shall
18. Antiscalant dosing Not provided No Operational membrane can Low Acceptable IQ
quality of the be provided before RO
damage the
water
membrane
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN FOR PURIFIED WATER PRE-TREATMENT, GENERATION, STORAGE &
& DISTRIBUTION SYSTEM

Risk GMP Justification Justification Risk Level Risk Control

S. Process Other Risk
Risk During
No. steps/component type -System to be designed
Yes/No no
with sanitization facility.
Microbial n operation of the
- As the water is
19. growth in Yes system the water No NA Medium Acceptable IQ & OQ
chlorinated the
filters. hold up will be
possibility of microbial
stagnant
growth is considerable
an
less.
d
possibility for
microbial growth.

Industrial RO unit shall

be provided where water
RO unit is is separated from
required to dissolved salts in
Not provided.
generate process solution by filtering
water required for through a semi
20. Industrial RO unit Sampling after Yes No NA High Acceptable IQ/OQ
purified water permeabl
RO is not
generation e membrane
possible.
system.
Sampling point after RO
Water quality shall be provided and
shall not be from the R.O product
checked water tank.
-If sufficient It should be designed in
water flow is not such a way that the water
available passing through CF,
cavitation of the should be equipped with
Feed Pump for Water flow pump takes level indicator and
21. Reverse Osmosis -1 rate is not No NA Operational place. Medium controller to give a Acceptable IQ & OQ
sufficient. - Pump can’t undisturbed continuous
deliver the flow to the R.O.
required
pressure of R.O
system.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN FOR PURIFIED WATER PRE-TREATMENT, GENERATION, STORAGE &
& DISTRIBUTION SYSTEM

Risk GMP Justification Justification Risk Level Risk Control

S. Process Other Risk
Risk Residual risk Verification
No. steps/component type Mitigation Method
Yes/No level
The RO unit shall be
provided with the
Various provision for monitoring,
process indicating and controlling
parameter like the pH, conductivity and
Critical GMP
22. Industrial RO unit pH, Yes No NA High flow rate of water. If the Acceptable IQ/OQ
process parameter
conductivity, output water is not
flow rate are meeting the desired result
not monitored the water will be drained
without collecting in the
potable water tank.
FINAL TREATMENT
The R.O shall be
chemically sanitizable,
and the system shall be
provide with CIP system
to clean and sanitize the
Possibility of R.O.
Purified water
microbial SOP for sanitization and IQ/OQ &
23. Industrial RO unit Yes quality will be No NA High Acceptable
growth in the interval for sanitization PQ.
affected.
industrial R.O shall be adopted during
validation.
The R.O filtered Potable
water shall be collected
in the HDPE tank for
easy cleaning.
Water quality
Water quality must The water shall be
fails at out
24. Industrial RO-2 Yes meet the specified No NA High dumped and recirculated Acceptable IQ& OQ
let of
conductivity to soft water tank.
RO+EDI unit.
Water with high
Does not have pH correction dosing
pH correction pH dosing not or low pH may
25. No impact on output Operational Low system shall be provided Acceptable IQ
dosing system provided damage the RO
water quality before industrial RO
membrane
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN FOR PURIFIED WATER PRE-TREATMENT, GENERATION, STORAGE &
& DISTRIBUTION SYSTEM

Risk GMP Justification Justification Risk Level Risk Control

S. Process Other Risk
Risk Residual risk Verification
No. steps/component type Mitigation Method
Yes/No level
The water quality
The operation may be affected by The manual The RO unit shall be
26. RO+EDI unit is not auto Yes manual operation Operational operation is High fully automatic and PLC Acceptable IQ& OQ
controlled of the RO unit due difficult. based.
to human errors.
Various
Yes Critical GMP No NA High The unit shall be Acceptable IQ& OQ
process
process parameter provided with the
parameter like
provision for monitoring,
pH,
Water quality shall indicating and controlling
conductivity, the pH, conductivity and
flow rate, not be checked
27. EDI flow rate of water.
TOC are not
monitored. Sampling point after EDI
Sampling shall be provided
point after
EDI not
provided.
STORAGE AND DISTRIBUTION OF PURIFIEDWATER
The purified water
generated shall be stored
It is difficult for
in a storage tank.
The water quality providing
No storage of
shall not be several user
28. Storage Tank purified water No Operational Low The purified water from Acceptable IQ& OQ
affected if not points from the
before use. the RO+EDI shall be in
stored. single point of
the loop and returned to
generation
the in-feed water storage
tank
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN FOR PURIFIED WATER PRE-TREATMENT, GENERATION, STORAGE &
& DISTRIBUTION SYSTEM
No water in the
tank, the
Pump will run
dry.
It may lead to The storage tank shall be
Low water The water level
damage the provided with level
29. Storage Tank level in the No shall not affect the Operational Low Acceptable IQ& OQ
pump and affect switch for water low
storage tank. water quality
the process. level.
Manual
observation of
the water level
is difficult
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN FOR PURIFIED WATER PRE-TREATMENT, GENERATION, STORAGE &
& DISTRIBUTION SYSTEM

Risk GMP Justification Justification Risk Level Risk Control

S. Process Other Risk
Risk Residual risk Verification
No. steps/component type Mitigation Method
Yes/No level
The Purified water buffer
storage tank shall be
provided with level
Overflow of
indicator for high water
Overflow of excess water
Over flow water level in the tank.
Purified water requires
30. No shall not affect Operational Low Acceptable IQ& OQ
from storage frequent
the water quality The flow to the tank shall
tank. cleaning of the
be stopped if tank is full
area
and the water flow shall
be in the loop return to
the RO feed tank.
Water
Spray balls will be
stagnant in the
Possibility of considered at the return
31. purified water Yes No NA High Acceptable IQ
Microbial growth. flow to create proper
collection
agitation.
tank.
A.3. Discharging of output
-The water distribution
Water shall be in a loop system.
contamination The water shall be in
Water
may increase due continuous flow in the
stagnancy in
to the bio-load in loop.
the
the Removal of -All pipeline shall have
distribution
distribution line to stagnant water drainable slope of
line to
32. Distribution Yes different Operational each time before High > 1:100 Acceptable IQ& OQ
different user
user use shall be very -The dead leg in the loop
points.
points. difficult. shall not be more than
1.5d. (d- diameter of the
No sampling
Sampling point is extended part)
point provided
required to check Sampling points shall be
water quality in provided at return loop
loop and user and all user points.
points
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN FOR PURIFIED WATER PRE-TREATMENT, GENERATION, STORAGE &
& DISTRIBUTION SYSTEM

Risk GMP Justification Justification Risk Level Risk Control

S. Process Other Risk
Risk Residual risk Verification
No. steps/component type Mitigation Method
Yes/No level
-Specified flow rate will
be maintained in the loop
Low flow rate
Flow rate in at supply and return line.
tends to bio-film
33. Distribution the loop is Yes No NA High -Flow switch will be Acceptable IQ& OQ
formation in the
low. considered on the return
pipe.
line with VFD
connection to the
distribution pump.
UV purifier shall be
Distribution
Water provided in the
loop is not
34. Distribution Yes contamination may No NA Medium distribution loop with Acceptable IQ& OQ
provided with
occur intensity meter for the
UV purifier
UVlamp
B. Equipment Construction
B.1. Internal Surface
Metallic critical contact
surfaces (piping, storage
tank for purified water)
shall be constructed of
316L grade stainless steel
or better, electro
polished, orbitally
welded after the outlet of
RO to the user point.
Internal For pretreatment stage all
May lead to the
surface is not interconnecting pipes
35. Surface Yes water No NA High Acceptable IQ
compatible shall be GI / SS304.
contamination
with the water
Supporting structure shall
be of SS304

Diaphragm Valves: SS
316L, electro polished

Purified water
distribution pipeline shall
be of SS316
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN FOR PURIFIED WATER PRE-TREATMENT, GENERATION, STORAGE &
& DISTRIBUTION SYSTEM

Risk GMP Justification Justification Risk Level Risk

S. Process Other Risk
Risk Control
No. steps/component type
Yes/No Residual risk Verification
Mitigation Method
level
Gaskets (shall be high
temperature &pressure
resistant)als and O-rings
coming in direct /indirect
Polymeric
contact surfaces shall be
materials are
Polymeric Shall lead to water made up of food grade
36. not compatible Yes No NA High Acceptable IQ
materials contamination polymeric materials
and are not
only. The easy change of
replaceable
gaskets must be possible.
Vendor shall provide the
certificate for food grade
polymeric material.
Weld joints Uneven and All welds shall be
not ground improperly ground ground finished to < 1.2
37. Welding Joints properly and Yes weld joints will No Na High µm Ra and properly Acceptable IQ
are not form a space for passivated and orbital
passivated dust accumulation welding should be done.

May lead to
improper cleaning
All internal metallic
of the surface
Internal finish surface shall be mirror
38. Finishing Yes which will lead to No Na High Acceptable IQ
is not proper polished with <0.4µmRa
microbial growth
hence product
contamination

Suitable gaskets shall be

provided for air tight
Water
connection which shall
39. Joints Joints are contamination No NA High Acceptable IQ
Yes be replaceable.
leaking may affect the
final water quality. Quick release Tri-clover
joints are recommended.
B.2. External Surface
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN FOR PURIFIED WATER PRE-TREATMENT, GENERATION, STORAGE &
& DISTRIBUTION SYSTEM

Risk GMP Justification Justification Risk Level Risk

S. Process Other Risk
Risk Control
No. steps/component type
Yes/No Residual risk Verification
Mitigation Method
level
Surface is not May lead to the
Supporting structures
40. Surface clean room Yes clean room No NA Medium Acceptable IQ
and frames shall be SS
suitable contamination
304.
External surface shall be
free from sharp edges,
External finish May lead to the
41. Finishing Yes No NA Medium corners, crevices etc., all Acceptable IQ
is not proper microbial growth
metallic external surface
shall be matt finished
Used lubricants Lubricant shall not enter
coming in contact in processing zone of
Lubricant used of the potential equipment.
is not food product contact An
42. Lubricant Yes No NA Medium Acceptable IQ
grade and is surfaces may lead y lubricant, if used in the
toxic in nature to the equipment must be food
contamination of grade andnon-toxic.
the product Vendor shall provide the
certificate
Non calibrated It should be possible to
Sensors not sensors may lead calibrate sensors (3-point
43. Sensors Yes No NA Low Acceptable IQ
calibratable to false machine calibration, full loop
functions calibration)
C. Equipment Automation
The equipment shall
control & detect failure
Process Possibility of mode automatically.
44. parameters are human error leads No Na High IQ& OQ
Process automation Yes The System shall be PLC Acceptable
not controlled to a process which
based and fully
automatically. is not validated
automatic.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN FOR PURIFIED WATER PRE-TREATMENT, GENERATION, STORAGE &
& DISTRIBUTION SYSTEM

Risk GMP Justification Justification Risk Level Risk

S. Process Other Risk
Risk Control
No. steps/component type
Yes/No Residual risk Verification
Mitigation Method
level

Cleaning and Cleaning process shall be

Possibility of performed by a
sanitization
Cleaning and human error leads automatically controlled
45. process No NA High IQ& OQ
sanitization Yes to a cleaning system. Acceptable
parameters are
automation procedure which is
not controlled Suitable PLC control
not validated
automatically shall be considered.
No means are Human Machine
Setting of process provided to interface:
and viewing / enter process Loca
46. Basic GMP No NA Medium Acceptable IQ& OQ
monitoring of parameters Yes l indication panel, local
requirement
parameters and indication switch panel auto for
of control operation of control
values value must be provided.
Control of Temperature indicator
Temperature is key
jacket cum controller shall be
47. Temperature Yes parameter for hot No NA Medium Acceptable IQ
temperature is provided for jacket
water sanitization
not provided temperature.

No indication Process critical System shall generate

is provided in control parameters audio-visual alarm and
GMP failure case of critical out of limit may print the alarms in case
48. Yes No NA High Acceptable IQ&
indication parameters are lead to the product critical process
OQ
out of limit of unacceptable parameters are out of
quality limit.

No indication
is provided for Water flow in the System shall generate
GMP failure critical loop continuously May lead to audio-visual alarm and
49. Yes EHS Medium Acceptable OQ
indication component is a GMP some accident print the alarms in case
failure e.g. requirement of critical System
Pump failure.

No indication System shall generate

May lead to the
GMP failure is provided for audio-visual alarm and
50. Yes water out of No NA Medium Acceptable OQ
indication utility supply print the alarms in case of
specification
failure utility supply failure
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN FOR PURIFIED WATER PRE-TREATMENT, GENERATION, STORAGE &
& DISTRIBUTION SYSTEM

Risk GMP Justification Justification Risk Level Risk

S. Process Other Risk
Risk Control
No. steps/component type
Yes/No Residual risk Verification
Mitigation Method
level
System does Yes No NA Medium Software used shall Acceptable IQ& OQ
Electronic data It is a basic GMP
not comply 21 comply to 21 CFR part 11.
control system requirement that
CFR part 11 vendor shall provide the 21
software, if used to
CFR part 11 compliance
generate, process,
certificate.
store the quality
51. critical electronic
data must be
validated and must
comply 21 CFR
Part 11
requirements
System security shall be
provided to access the
Unauthorized
Uncontrolled operating system and
access may lead to
Electronic data access to the configurable parameter
52. Yes uncontrolled No NA High Acceptable OQ
control system operating values through access
change in critical
system password (3 level access
process parameter
to operating parameter
shall be preferred)
No process Local display panel shall
display and be provided to display
record printing critical parameter and
Process Display Basic GMP
53. system is Yes No NA Medium batch printing system Acceptable OQ
and record printing requirement
provided shall be provided for
printing of critical
process parameters
D. System Cleaning and sanitization
The external surface
shall be smooth for easy
manual cleaning.
Cleaning is Cleaning is basic
54. Cleaning Yes No NA Medium Acceptable IQ& OQ
not possible GMP requirement
The storage tank and
distribution system shall
be hot water cleanable.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN FOR PURIFIED WATER PRE-TREATMENT, GENERATION, STORAGE &
& DISTRIBUTION SYSTEM

Risk GMP Justification Justification Risk Level Risk

S. Process Other Risk
Risk Control
No. steps/component type
Yes/No Residual risk Verification
Mitigation Method
level
The industrial RO shall
be chemical sanitizable
Sanitization of the
The RO shall be hot
Sanitization water system is
55. Sanitization Yes No NA Low water sanitizable Acceptable IQ& OQ
not possible basic process and
GMP requirement
The storage tank and
distribution line shall be
hot water sanitizable
E. System safety
All electrical systems
shall be tested for safety
and shall be provided
Electrical
with safety markings e.g.
systems are May lead to an
56. Electrical system No NA EHS Medium C.E. marking. Acceptable IQ
not verified accident
The noise liberated by the
for safety
system shall not be more
than 80 db from 1m from
the system.
Emergency Emergency stop shall be
57. Electrical system No NA EHS NA Low Acceptable IQ
stop in the accessible limit.
On power failure System
System
May lead to must come to rest to
58. Power failure doesn’t comes No NA EHS Medium Acceptable OQ
some accident protect operator and
to rest
System itself
Power restart must not
Power restart May lead to a be automatic and human
59. Power failure No NA EHS Medium Acceptable OQ
automatic fatal accident intervention must be
required.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN FOR PURIFIED WATER PRE-TREATMENT, GENERATION, STORAGE
& & DISTRIBUTION SYSTEM

Risk GMP Justification Justification Risk Risk Control

S.No. Process Other Risk Level
Risk Residual risk Verification
steps/component type Mitigation Method
Yes/No level
Compressed air pressure
Improper function
May leads shall be indicative with
of pneumatic
Compressed improper alarm if low.
60. Power failure Yes instruments leads Operational High Acceptable IQ &OQ
air is low function of the The total system shall be
to improper
system shut down if the
output.
compressed air is low.
F. Documentation
▪ Vendor documentation
(English) shall comprise:
-Data sheets
-Material certificates
-Operating instructions
-Maintenance
instructions and intervals
-Calibration instructions
Adequate -Parts lists(sufficient
technical detailed: part number,
Technical
documentation is supplier, type)
documentation
61. Vendor Documents Yes basic GMP No NA Medium Acceptable OQ
from vendor ▪ Drawings
requirement for
not adequate - P&I-diagrams
qualification and
- Electrical diagrams
operation of the
- (Certificates of
System
initial calibration of
sensors); GA
drawings
▪ Running trial certificate.
▪ Certificate of bought out
▪ Relevant
SOP
components
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN FOR PURIFIED WATER PRE-TREATMENT, GENERATION, STORAGE
& & DISTRIBUTION SYSTEM
9.0 Summary and Conclusion:

▪ The risk assessment is performed to establish the design parameters of the equipments as to meet the desired performance of the System.
▪ The critical risks pertaining to GMP and other than GMP were analyzed with justification and mitigation procedures.
▪ For each recognized GMP-risk and other than GMP risks necessary measures are defined. Organizational measures, like SOP’s, are also possible
measures for special GMP-risks. The availability of these SOP’s will be checked at the time of accomplishment to OQ of the system.
▪ To control the risk, various mitigation methods shall be verified through SOP’s, operation & maintenance manuals, and calibration certificates at
respective verification points.
▪ Based on Risk assessment, the URS shall be prepared.

“It is concluded that the Risk Assessment performed for the equipment will mitigate the risk of failures of critical parameters during design, commissioning, installat ion,
operation and performance of the system”.