PROTOCOL

FOR
PERFORMANCE QUALIFICATION (PQ)
OF
PURIFIED WATER GENERATION, STORAGE AND
DISTRIBUTION SYSTEM
PLANT LOCATION:XXXXXXXXX
Docume! No"
Su#e$%e&e%
E''ec!()e D*!e
Re)(e+ D*!e
No" O' P*,e%
Re'e$ece P$o!oco- No"
COMPANY NAME
ADDRESS
Page 2 of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: !ffecti"e Date:
PROTOCOL CONTENTS
S" No" SECTION TITLE P*,e No"
."/ P$o!oco- A##$o)*-"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""0
1"/ O)e$)(e+"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""2
1". O34ec!()e:"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""2
1"1 Pu$#o%e *& Sco#e""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""2
1"0 Re%#o%(3(-(!5""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""6
1"2 Qu*-('(c*!(o Te*m:"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""6
0"/ T$*((, Reco$&"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""7
2"/ P$e 8 Qu*-('(c*!(o Re9u($eme!%""""""""""""""""""""""""""""""""""":
6"/ Pe$'o$m*ce Qu*-('(c*!(o De%c$(#!(o"""""""""""""""""""""""""";
6". Gee$(c De%(,""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""";
6"."6"2 Te%! P$o,$*mme:"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""".6
6"1 Re9u($e& W*!e$ S#ec('(c*!(o%""""""""""""""""""""""""""""""""""""""""""".:
6"0 Te%! S#ec('(c*!(o, S*m#-(, P-* < F$e9uec5""""""""""""""1/
6"2 Re9u($e& SOP=%"""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""""12
6"6 E)*-u*!(o o' Re%u-!%""""""""""""""""""""""""""""""""""""""""""""""""""""""""""16
7"/ Pe$'o$m*ce Qu*-('(c*!(o P$oce&u$e""""""""""""""""""""""""""17
:"/ Acce#!*ce C$(!e$(*"""""""""""""""""""""""""""""""""""""""""""""""""""""""1:
;"/ Qu*-('(c*!(o Re#o$!""""""""""""""""""""""""""""""""""""""""""""""""""""""1:
>"/ A##$o)*- o' Qu*-('(c*!(o Re#o$!"""""""""""""""""""""""""""""""""1:
./"/ O3%e$)e& De)(*!(o""""""""""""""""""""""""""""""""""""""""""""""""""""""""1;
.."/ L(%! o' E?@(3(!% A Ae?u$e""""""""""""""""""""""""""""""""""""""""""""1>
.1"/ Re'e$ece Docume!%"""""""""""""""""""""""""""""""""""""""""""""""""""""0/
Page # of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: !ffecti"e Date:
1.0 P$o!oco- A##$o)*-
$%is is a s&ecific &rotocol for Performance Qualification of &urified 'ater generation,
storage and distribution system.
$%is &rotocol %as been a&&ro"ed by t%e follo'ing:
N*me De#*$!me! S(,*!u$e D*!e
P$e#*$e& B5
C@ecBe& B5
A##$o)e& B5
F(*- A##$o)*-:
(inal a&&ro"al %as been gi"en by t%e follo'ing:
N*me S(,*!u$e D*!e
A##$o)e& B5
(P-*! Ce*&)
A##$o)e& B5
(Ce*& 8 QA)
Page 4 of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: !ffecti"e Date:
2.0O)e$)(e+
2.1 O34ec!()e:
$o establis% t%e met%odology for t%e &erformance )ualification of &urified 'ater system, '%ic%
is used for generation, storage and distribution of &urified 'ater in solid oral and li)uid oral
bloc* including )uality control De&artment.
2.2 Pu$#o%e *& Sco#e
$%e &ur&ose of t%is &rotocol is to &ro"ide a documentary e"idence for t%e &erformance
)ualification of t%e 'ater system:
$o ensure t%at &urified 'ater meets t%e P%armaco&oeial s&ecifications of +P and ,SP.
$o confirm t%e a&&ro&riateness of critical &arameters of t%e 'ater system com&onents.
$o &erform &urified 'ater drain time study during sam&ling.
$o &erform %old time study for stored &urified 'ater in t%e 'ater storage tan*.
$o establis% reliability of 'ater system.
$o finali-e o&erating S.Ps of 'ater system.
$o establis% /lert and /ction le"els.
$o establis% t%e efficacy of saniti-ation &rocedures.
$o "alidate t%e system and c%ec* its &erformance for one year in order to co"er all t%e
seasonal "ariations.
$%is &rotocol is a&&licable to &urified 'ater generation, storage and distribution system,
Equipment Tag No.____
Page 5 of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: !ffecti"e Date:
2.3 Re%#o%(3(-(!5
P$o!oco- A Re#o$! P$e#*$*!(o: Quality 0ontrol !1ecuti"e, Quality /ssurance !1ecuti"e and
!ngineering !1ecuti"e
A##$o)*- o' P$o!oco- A Re#o$!: Quality /ssurance 2anager 3 4ead5Quality /ssurance
E?ecu!(o o' Qu*-('(c*!(o Ac!()(!5: Quality 0ontrol !1ecuti"e, Ser"ice !ngineer
2.4 Qu*-('(c*!(o Te*m:
Quality 0ontrol !1ecuti"e 3 2anager
Pro6ect !1ecuti"e 3 2anager
7alidation 2anager
Quality /ssurance 2anager
Page 8 of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: !ffecti"e Date:
3.0T$*((, Reco$&
3.1 Pu$#o%e
$%e &ur&ose of t%e training is to familiari-e t%e trainees 'it% t%e &rinci&le of 'or*ing 9
tec%nical s&ecifications of 'ater system as 'ell as o"erall strategy of Performance
Qualification of t%e Water System.
3.2 Sco#e
$%is $raining is related to t%e &urified 'ater generation, storage and distribution system and
being im&arted to t%e &eo&le in"ol"ed in t%e 'ater system "alidation.
3.3 To#(c%
$%e follo'ing to&ics s%all be co"ered during training:
Princi&le of 'or*ing of 'ater system.
$ec%nical s&ecifications of t%e system com&onents.
."erall strategy of Qualification &rocess.
General &recautions 3 guidelines to be follo'ed during )ualification.
Note: -
Training shall be given as per SOP Title: __________________________ SOP No.:
_____________________.
Training record shall be attached with the report as nne!ure-"#
Page : of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: !ffecti"e Date:
4.0P$e 8 Qu*-('(c*!(o Re9u($eme!%
(ollo'ing instruments s%all be re)uired for t%e &erformance )ualification of &urified 'ater
generation, storage and distribution system.
S$"
No"
E9u(#me! N*me
E9u(#me! Co&e
A S$" No"
C*-(3$*!(o
Ce$!('(c*!e No"
C*-(3$*!(o Due
O
1. &4 2eter
2. $DS 3 0onducti"ity
2eter
3. $.0 /naly-er
Page ; of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: !ffecti"e Date:
5.0Pe$'o$m*ce Qu*-('(c*!(o De%c$(#!(o
6". Gee$(c De%(,
6".". I !$o&uc!(o
,nited State P%armaco&oeia <,SP2=> recommends t%e follo'ing s&ecifications for Purified
Water <PW> in t%eir monogra&% for P%armaceutical +ndustry.
<a> &4 : 5 ? :
<b> 0onducti"ity : @ A.# BS3 cm at 25 C 0 <Stage5A <.n5line>>
<c> $.0 : @ 5DD &&b
<d> $otal Eacterial 0ount: @ ADD cfu 3 ml
Similarly +ndian P%armaco&oeia <+P A==8> recommends t%e follo'ing s&ecifications for Purified
Water <PW> in t%eir monogra&% for t%e &%armaceutical industry.
<e> /cidity 3 /l*alinity : $o com&ly
<f> /mmonium +ons : $o com&ly
<g> 0a
2F
3 2g
2F
+ons : $o com&ly
<%> 4ea"y 2etals : N2$ D.A &&m
<i> Nitrate : $o com&ly
<6> 0%loride : $o com&ly
<*> Sul&%ate : $o com&ly
<l> .1idisable substances : $o com&ly
<m>Gesidue on !"a&oration : N2$ Amg <D.DDAH>
<n> $otal Eacterial 0ount : @ ADD cfu 3 ml
4o'e"er, t%e 'ater system %as been designed considering ,SP52= and +P A==8 s&ecifications,
as t%e basis of ma1imum allo'able &arameters at eac% user &oint, along5'it% suitable Design
Iimits, /lert Iimits and /ction Iimits.
6"."1 S5%!em &e%(, &e!*(-%
$%e 'ater system design %as t%e follo'ing ma6or stages of &urification, distribution and control.
a> Pre5treatment System for (iltration and softening of ra' 'ater to &roduce soft 'ater 3
&otable 'ater.
b> Generation System for Purified Water <using ,(5G.5!D+ system>
c> Storage and Distribution System for Solid .ral Eloc*
d> Storage and Distribution System for Ii)uid .ral Eloc*
e> Programmable Iogic 0ontrol for &re5treatment, generation and distribution loo& system.
6"."0 P$eD!$e*!me!
Page = of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: !ffecti"e Date:
$%e ob6ecti"e of &re5treatment is to treat ra' 'ater and &roduce feed 'ater <'it%in t%e limit of
&otable 'ater 3 soft 'ater> for t%e final &urification system.
Water, used as feed 'ater for t%e &re&aration of Purified Water, must meet t%e drin*ing 'ater
s&ecifications. $%erefore, &re5treatment of t%e ra' 'ater is e)ually im&ortant, as it is designed
to &roduce 'ater com&lying 'it% &%armaco&oieal s&ecifications for drin*ing 'ater. $%is reduces
t%e load on t%e final &urification system and ma1imi-es t%e efficiency of t%e final &urification
stage.
$%e ra' 'ater is stored in t%e Day Storage tan*. $%e ra' 'ater may %a"e sus&ended solids,
dissol"ed im&urities, colloids, organics, bacterial im&urities, etc. /ll t%ese im&urities may foul t%e
G. membranes 3 any filters being used do'n stream. 4ence, it is desirable to reduce t%e
im&urities to a s&ecified le"el by &re5treatment.
(ollo'ing treatments ste&s %a"e been designed in t%e &re5treatment stage to &roduce soft 'ater:
6"."0". C@-o$(e Do%(, S5%!em
.nline 0%lorine Dosing <0%lorine Dosing> %as been &ro"ided, to disinfect t%e feed 'ater as 'ell
as control t%e microbial contamination le"els. 0%lorine Dosing is done by addition of Sodium
%y&oc%lorite at a concentration of #58 mg 3 Iitre. (ree c%lorine is normally maintained at a le"el
of about D.A ? D.# &&m. 4o'e"er, t%e concentration of c%lorine le"el may be ad6usted, on t%e
basis of microbiological contamination in feed 'ater.
(ree c%lorine in 'ater also reduces t%e &ossibility of bacterial germination in t%e 2ulti grade
(ilter and Softener stages, '%ic% are ot%er'ise &otential breeding grounds for bacteria.
6"."0"1 Mu-!( ,$*&e F(-!e$
2ulti grade Sand (ilter %as been installed, '%ic% is %a"ing multi&le layers of &ebbles, gra"els and
sand. $%e 0oagulated sus&ended &articles, formed due to addition of c%emicals in earlier ste&s,
are remo"ed from t%e ra' 'ater. $%is treatment also reduces silica and ot%er sus&ended &articles
from t%e ra' 'ater.
6"."0"0 So'!ee$ U(!
$'o Softener units %a"e been &ro"ided in t%e &re5treatment stage, in order to reduce t%e
%ardness of 'ater to @5&&m.
$%ese t'o softener columns 'or* alternately, in order to &ro"ide a continuous flo' of 'ater,
during regeneration of eit%er one of t%e columns. !ac% softener column is regenerated in
a&&ro1imately AD %rs. During regeneration of Softener 5 A, t%e 'ater is di"erted to Softener ? 2
by t%e o&eration of &neumatically o&erated "al"es.
$%e soft 'ater, generated by t%e softener, is stored in a JSoft 'ater Storage $an*K, in order to
&ro"ide t%e necessary buffer re)uired for t%e daily usage.
/ minimum le"el of c%lorine <N2$ D.5 &&m> is maintained, in t%e Jsoft 'ater storage tan*K
during t%e &rocess, to minimi-e t%e bacterial gro't% in t%e softener bed.
6"."0"2 So'! W*!e$ S!o$*,e T*B
Page AD of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: !ffecti"e Date:
$%e Jsoft 'aterK, generated by softener, is stored in JSoft 'ater Storage $an*K. $%is tan* %as
been &ro"ided 'it% J'ater le"el transmittersK to monitor t%e 'ater le"el in t%e tan*.
$%e soft 'ater is furt%er su&&lied to t%e &lant, for ,tility /&&lications, t%roug% soft 'ater
transfer &um&.
6"."2 Gee$*!(o %5%!em 'o$ Pu$('(e& W*!e$
$%e ob6ecti"e of generation system is to &ro"ide t%e &urified 'ater to t%e Purified Water Storage
tan* on demand before t%e same is distributed to t%e final user &oints by means of a&&ro&riate
&i&ing in t%e &lants.
$%e soft 'ater is &assed t%roug% Jacti"ated carbon filterK </0(> for t%e remo"al of c%lorine,
E.D and 0.D. /0( filtered 'ater is furt%er &assed t%roug% micron cartridge filter, ,7 column
and ultra5filtration system, for remo"al of sus&ended &articles and microbial contamination. $%e
,(5treated 'ater of ultra filtration system is stored in SS tan*.
$%e &urified5'ater generation system is designed 'it% Jdouble5&ass G.5systemK and J!D+5
systemK for remo"al of dissol"ed salts. $%e G.5!D+ treated 'ater is furt%er &ass t%roug% a J,7
columnK, to control t%e microbial gro't% in treated 'ater. $%e ,75column treated5'ater, '%ic%
)ualifies ,SP3+P s&ecifications for &urified 'ater, is transferred to t%e J&urified 'ater storage
tan*s for Solid .ral Eloc* and Ii)uid .ral Eloc* res&ecti"ely.
(ollo'ing treatments ste&s %a"e been designed in t%e generation stage:
6"."2". Ac!()*!e& C*$3o F(-!e$
/cti"ated carbon filter remo"es free c%lorine, as 'ell as colour 3 odour, E.D 9 0.D etc. from
t%e soft 'ater, to safe guard G. membranes. /0( %as been &ro"ided as an add5on safety
feature, for remo"al of E.D 3 0.D from feed 'ater.
6"."2"1 M(c$o C*$!$(&,e F(-!e$
Sus&ended &articulates in feed5'ater may c%o*e t%e ,(5membrane &assage and may also
damage t%e ,(5membranes, t%us affecting &erformance 9 life of ,(5system.
/ 55micron cartridge filter remo"es t%e sus&ended &articulates from t%e feed 'ater.
Pressure Gauges across t%e J55micron cartridge filterK %a"e been &ro"ided, in order to identify
t%e c%o*ing of cartridge filter and facilitate its re&lacement. $%e 55micron cartridge filter %as
large surface area and may &ro"ide t%e breeding ground for microbial gro't%. /ccordingly, t%e
c%lorinated 'ater &re"ents t%e gro't% of microbial load. (ree c%lorine &resent in 'ater &re"ents
any microbial gro't% in 55micron cartridge filter.
6"."2"0 U-!$* E(o-e! S5%!em
/ ,7 system %as been &ro"ided at t%e 2icron 0artridge (ilterLs outlet, as an additional safety
measure, to control t%e microbial load in t%e ,ltra (iltration system.
6"."2"2 U-!$*D'(-!$*!(o, Re)e$%e O%mo%(% < E-ec!$oDDe(o(F*!(o S5%!em
6"."2"2". U-!$*D'(-!$*!(o S5%!em
Page AA of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: !ffecti"e Date:
,ltra5filtration <,(> system is used for remo"al of microbial contamination 9 0.D etc.
,ltra5filtration system is a membrane se&aration &rocess. +t em&loys a cross flo' &at% of 'ater,
across a membrane, '%ere t%e &urified5'ater 9 re6ect5'ater are se&arated out continuously. $%e
re6ect5'ater, containing t%e se&arated bacteria, is continuously drained, t%us a"oiding t%e
accumulation of bacteria in t%e &urified5'ater.
$%e ,( system is saniti-ed by using a&&ro&riate saniti-ing c%emicals. +n addition, t%e ,( system
is &eriodically bac*5'as%ed by using ,(5&ermeate 'ater 3 &urified5'ater.
6"."2"2"1 A!(D%c*-*! Do%(, S5%!em
$%e salts, &reci&itated during desalination &rocess, tend to de&osit on t%e G.5membrane surface,
t%us affecting t%e &erformance of G.5system. +n order to a"oid de&osition of salts on G.5
membranes, a&&ro&riate anti5scalant agent dosing is &ro"ided, '%ic% reduces salt5de&osition 9
ma1imi-es cleaning cycle inter"al for t%e G.5membranes.
6"."2"2"0 #C Co$$ec!(o Do%(, S5%!em
/&&ro&riate &4 correction dosing system <for &4 correction of G.5feed5'ater> %as been
&ro"ided in order to maintain t%e )uality of G.5&ermeate 'ater. /n al*aline &4 ensures t%e
remo"al of dissol"ed 0.2 from t%e system during desalination. / &4 controller &40D85AADA
monitors 3 controls t%e &4 of t%e feed5'ater.
6"."2"2"2 SMBS Do%(, S5%!em
(ree c%lorine in t%e feed5'ater can damage t%e Polyamide G. membranes. $%erefore free
c%lorine %as to be remo"ed from t%e feed5'ater. +n t%e designed &urification sc%eme, /0(
remo"es free c%lorine from t%e 'ater.
4o'e"er, additional safeguard system in t%e form of JS2ES dosing systemK %as been &ro"ided
to ensure t%e safety of G.5membranes.
$%e free c%lorine in soft 'ater is effecti"ely remo"ed by dosing of sodium metabisul&%ite
solution. +n order to detect free c%lorine, an online Jc%lorine analyserK %as been &ro"ided, '%ic%
o&ens t%e dum& "al"e on sensing free c%lorine, t%ereby dum&ing t%e 'ater, till t%e c%lorine le"els
in t%e feed5'ater are 'it%in &ermissible limits. $%e system is tri&&ed if t%e c%lorine is detected
during normal o&eration to &rotect t%e G. membranes.
6"."2"2"6 M(c$o C*$!$(&,e F(-!e$
Sus&ended &articulates in feed5'ater may c%o*e t%e G.5membrane &assage and may also
damage t%e G.5membranes, t%us affecting &erformance 9 life of G.5system.
/ 55micron cartridge filter remo"es t%e sus&ended &articulates from t%e feed 'ater.
Pressure Gauges across t%e J55micron cartridge filterK %a"e been &ro"ided, in order to identify
t%e c%o*ing of cartridge filter and facilitate its re&lacement..
6"."2"2"7 Bu''e$ T*B
Page A2 of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: !ffecti"e Date:
/n on5line 6ac*eted buffer tan* , 'it% electrical %eating system in t%e 6ac*et, %as been &ro"ided
at t%e inlet of Jt'o &ass G.5systemK. $%is tan* is also used during %ot 'ater saniti-ation or
c%emical cleaning of t%e G.5membrane. Since t%e tan* is in5line during t%e o&eration, t%is
arrangement reduces t%e &ossibility of bio5film formation in t%e tan* , during stagnation or idle
conditions.
6"."2"2": T+o P*%% Re)e$%e O%mo%(% S5%!em
$%e &re5treated 'ater is furt%er &assed t%roug% JGe"erse .smosis <G.> 2oduleK for &rimary
salt reduction from t%e soft 'ater.
Ge"erse .smosis is t%e &rocess, '%ic% remo"es t%e dissol"ed salt molecules by filtration t%roug%
&olyamide semi5&ermeable membranes. $%e G.5system o&erates abo"e t%e osmotic &ressure,
t%ereby facilitating re"erse osmosis and reduction of salt content by =D5=5H.
Ge"erse .smosis also remo"es sus&ended &articulates and reduces total organic carbon <$.0>
&resent in t%e feed5'ater.
$%e G. system can reduce total dissol"ed solids <$DS> in t%e &ermeate5'ater to le"els, '%ic%
are less t%an ADD &&m.
6"."2"2"; Seco& P*%% RO S5%!em
$%e G.5&ermeate 'ater is t%en &assed t%roug% second &ass of G.5membranes, for furt%er
reduction of $DS, sus&ended &articulates 9 $.0. $%e second &ass G.5system can reduce $DS
in &ermeate 'ater to le"els less t%an 2D&&m.
$%e G. system %as been designed for &eriodic saniti-ation 'it% %ot 'ater.
6"."2"2"> E-ec!$oDDe(o(F*!(o S5%!em
$%e G.5&ermeate 'ater is furt%er sub6ected to !lectro5deioni-ation &rocess to bring do'n t%e
o"erall conducti"ity @ A.D micro5siemens3cm.
Since G.5system is not sanitary in construction, t%e G.5&ermeate 'ater may %a"e some ionic
load during &rolonged o&eration.
$%e G.5&ermeate 'ater is t%erefore treated 'it% !lectro5deioni-ation <!D+> &rocess to remo"e
ionic load and reduce conducti"ity.
$%e !D+ is eit%er bac*5flus%ed 'it% &ermeate 'ater or c%emically saniti-ed, if it becomes
necessary, as &er Su&&lier recommended &rocedures.
6"."2"2"./ U-!$* E(o-e! S5%!em
/ ,7 system %as been &ro"ided at t%e !D+ outlet, as an additional safety measure, to control t%e
microbial load in t%e Purified 'ater. $%us t%e 'ater coming at outlet is c%aracteri-ed as
MPurified WaterL and tested against t%e ,SP2=3+PA==8 s&ecifications of Purified Water.
6"."6 S!o$*,e A& D(%!$(3u!(o S5%!em De%c$(#!(o
Page A# of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: !ffecti"e Date:
$%e &urified 'ater, generated by 'ater system, is fed to t%e J&urified 'ater storage tan*s, on
demand, &rior to t%e distribution to final user &oints. $%e storage tan*s ca&acities %a"e been
arri"ed at, *ee&ing in mind t%e &ea* load 9 buffer "olumes to be maintained.
$%e &urified 'ater, stored in t%e J&urified 'ater storage tan*s, is su&&lied to "arious usage
&oints in t%e &lant, by means of a &i&ing3distribution net'or*, '%ic% is a Jclosed loo& systemK.
$%e 'ater &i&ing3distribution system is being maintained at ambient tem&erature.
,7 0olumn : Since t%e 'ater distribution system is being maintained at ambient tem&erature,
t%erefore Mbacterial load controlL 'ill be of ma6or concern. Eacterial load control is being ta*en
care off by an Jonline ,7 columnK, '%ic% is installed in t%e J'ater distribution loo&K &rior to its
distribution to t%e user &oints.
/n Jintensity monitorK along5'it% an Jonline sensor and &anel mounted monitorK %as also been
installed, '%ic% 'ill monitor t%e intensity of t%e ,75tubes, at any instance and facilitate t%eir
re&lacement at a&&ro&riate fre)uency.
0onducti"ity Sensor : $%e )uality &arameters of &urified5'ater system, suc% as conducti"ity, are
continuously monitored and &ro"ide necessary control for t%e 'ater system o&eration. +n case of
any de"iation in t%e 'ater )uality, Jnecessary tri&&ing3alarmK are triggered, in order to dra' t%e
attention of t%e system o&erator. (or t%is &ur&ose, an Jonline conducti"ity sensorK %as been
installed, '%ic% can actuate a drain 3 dum& "al"e <on de"iation from set limits> and &re"ent
&urified 'ater from being distributed to t%e user &oints. $%is safeguards t%e users from using
&oor )uality 'ater.
Pu$('(e& W*!e$ S!o$*,e T*B%:
$%e J&urified 'ater storage tan*s %a"e been designed as 6ac*eted tan*s, for %eating 'it% steam
during saniti-ation. $%e saniti-ation is &erformed by acti"ating a steam control "al"e, '%ic% is
controlled by an Jonline tem&erature controllerK for maintaining t%e 'ater distribution systems
at an ele"ated tem&erature for a sti&ulated &eriod of time.
(or safe 'or*ing of t%e 'ater system, J'ater le"el controllersK %a"e been &ro"ided in t%e
storage tan*s, '%ic% &re"ent t%e tan*s from o"erflo'ing as 'ell as safeguard t%e &um&s from
running dry. +n case of %ig% 'ater le"el in storage tan*, 'ater can be di"erted to t%e &rocess
'ater tan*.
Pu$('(e& W*!e$ D(%!$(3u!(o Loo#%:
$'o se&arate loo&s %a"e been &ro"ided, for Solids oral 9 Ii)uid oral bloc*s. Eot% t%e loo&s are
identical in design and basic control systems, but are designed for t%e agreed user re)uirements
for res&ecti"e loo&s.
6"."6". S!o$*,e < D(%!$(3u!(o S5%!em 'o$ So-(& O$*- B-ocB:
$%e storage 9 distribution of &urified 'ater, for Solid .ral Eloc*, is designed 'it% a closed loo&
system. /ll t%e user &oints, in t%e Solid .ral Eloc*, %a"e been &ro"ided 'it% a -ero dead leg
"al"e. /lso a minimum "elocity of 'ater is maintained in t%e entire loo&. Storage and
Distribution system %a"e been designed as &er t%e guidelines of +SP! for minimum "elocity in
t%e loo& as 'ell as turn o"er in storage tan* etc. $%e &urified 'ater storage tan* %as been
Page A4 of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: !ffecti"e Date:
designed as a steam56ac*eted tan*, to facilitate &eriodic saniti-ation of t%e entire loo&, using %ot
'ater.
6"."6"1 S!o$*,e < D(%!$(3u!(o S5%!em 'o$ L(9u(& O$*- B-ocB:
$%e storage 9 distribution system of &urified 'ater, for Ii)uid .ral Eloc*, is similar in design
and configuration 3 controls to t%e Solid .ral Eloc*, 4o'e"er, t%e entire system %as been
dedicatedly designed to meet t%e Ii)uid .ral Eloc* re)uirement.
6"."6"0 P$o,$*mm*3-e Lo,(c Co!$o- 'o$ #$eD!$e*!me!, ,ee$*!(o *& &(%!$(3u!(o -oo#
%5%!em"
Se&arate PI0 3 &anels %a"e been &ro"ided for &re5treatment stages, ,(5G.5!D+ stages of
&urified 'ater generation, as 'ell as for storage 9 distribution system for solid and li)uid oral
bloc*s.
Pre5treatment &lant %as been &ro"ided 'it% a se&arate PI0 system and a man mac%ine interface
<22+> on t%e control &anel, located in t%e &re5treatment bloc*. /ll t%e necessary interloc*s 3
controls are monitored by PI0 for t%e o&erational status.
Purified 'ater generation and distribution systems %a"e been &ro"ided 'it% se&arate PI0 and
200 &anels. $%e control &anel is &ro"ided 'it% AD5inc% touc% screen 22+ for &lant o&erations.
$%e &lant &eo&le can also access t%e system for o&eration and data ac)uisition, using
su&er"isory control as &er design.
6"."6"2 Te%! P$o,$*mme:
$%e Performance Qualification of 'ater system s%all be carried out in t%ree &%ases:
<a> P%ase5A ? e1tensi"e sam&ling from Generation &oints 9 usage &oints for 4 'ee*s
<b> P%ase52 ? e1tensi"e sam&ling from selecti"e generation 9 all usage &oints for # mont%s
<c> P%ase5# ? routine sam&ling from usage &oints on rotation basis, for ; mont%s
$%e detailed met%odology of t%e # &%ases of "alidation is as gi"en belo':
P@*%e D .: (Fo$ * #e$(o& o' 2 +eeB% A 1; &*5%)
$%e &erformance )ualification of 'ater system s%all be started, '%en all t%e e)ui&ment and
&i&ing of 'ater system %a"e been "erified to be installed &ro&erly and are o&erating correctly.
P%ase5A of t%e &erformance )ualification of 'ater system s%all include e1tensi"e sam&ling of
'ater, from "arious &oints in t%e &re5treatment system and &urified 'ater generation system
along 'it% all t%e usage &oints of t%e distribution loo&s <as described in sec. 5.8>. $%e &%ase5A
sam&ling s%all be carried out for a &eriod of 4 'ee*s.
During t%is &%ase 'ater sam&les from t%e c%osen generation 3 usage &oints s%all be analy-ed and
monitored for com&liance to t%e &re5determined s&ecifications <as described in t%e section 5.4>.
/fter successful com&letion of P%ase5A of t%e &erformance )ualification, t%e Purified Water
system s%all be cleared for usage of Purified 'ater in manufacturing o&erations. Pur&ose of
Page A5 of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: !ffecti"e Date:
P%ase5A )ualification is to stabili-e t%e o&erating &arameters and de"elo& t%e cleaning 3
saniti-ation &rocedures 3 saniti-ation fre)uencies 3 sam&ling met%ods 3 drain time study and %old
time study. 0onclusions s%all be described in a summary re&ort.
During P%ase5A, 'ater sam&les s%all also be collected for drain time study and %old time study.
$%e follo'ing &rocedure s%all be follo'ed for drain time 9 %old time study:
D$*( T(me S!u&5:
Drain time study for &urified 'ater s%all be done during I%! #@*%e. Sam&les s%all be dra'n from
t%e last user &oint considering t%e 'orst case on e"ery 'ee*end for first t%ree 'ee*s. Sam&les
s%all be collected at D, 5 9 AD minutes '%ile t%e cor* is o&en and s%all be c%ec*ed for bio
burden as &er t%e s&ecifications of &urified 'ater.
Co-& T(me S!u&5:
4old time study for &urified 'ater s%all be done during I%! #@*%e. Sam&les s%all be dra'n from
t%e last user &oint considering t%e 'orst case on e"ery 'ee*end for first t%ree 'ee*s. Purified
'ater s%all be collected and *e&t in t%e container and sam&le s%all be 'it%dra'n at D, A, #, 5, ;
9 A2 %ours. Sam&les s%all be c%ec*ed for bio burden as &er t%e s&ecifications of &urified 'ater.
P@*%e 8 1: $%or a period o& ' months(
P%ase52 of t%e &erformance )ualification s%all commence, after successful com&letion of P%ase5
A. Pur&ose of P%ase52 )ualification is to monitor t%e o&erating &arameters as 'ell as cleaning 3
saniti-ation &rocedures 3 saniti-ation fre)uencies 3 sam&ling met%ods. $%e ob6ecti"e of P%ase52 is
also to demonstrate t%at system 'ill &roduce desired )uality of 'ater, on a consistent basis,
'%en o&erated in conformance 'it% S.P establis%ed at t%e end of P%ase5A. 0onclusions s%all be
mentioned in Summary re&ort.
During P%ase52, 'ater sam&les s%all be collected from all t%e Sam&ling Points and ,sage Points
on a Daily basis <Sam&ling &lan mentioned in 5.8>. P%ase52 of t%e &erformance )ualification of
'ater system s%all include e1tensi"e sam&ling of 'ater, from end &oints in t%e &urified 'ater
generation system <as described in sec. 5.4.2> 9 all t%e usage &oints of t%e distribution loo&s <as
described in sec. 5.4.#>, daily. P%ase52 sam&ling s%all be carried out for a &eriod of # mont%s.
Water sam&les from t%e all t%e c%osen usage &oints s%all be analy-ed and monitored, daily, for
com&liance to t%e &re5determined s&ecifications <as described in t%e section 5.5>.
/fter successful com&letion of P%ase52 of t%e &erformance )ualification, t%e Purified Water
system s%all be cleared for P%ase5#.
P@*%e 8 0: $%or a period o& ) months(
P%ase5# s%all commence immediately after com&letion of P%ase52. $%e ob6ecti"e of P%ase52 is
to demonstrate t%at t%e 'ater system is ca&able of &roducing consistent )uality 'ater, by ta*ing
care of all &ossible seasonal "ariations, '%en o&erated in accordance 'it% t%e establis%ed S.PLs
o"er a long &eriod of time. $%e sam&ling s%all be done as &er t%e routine sam&ling &rocedures.
Sam&les s%all be collected from selected Sam&ling &oints once a 'ee* and s%all randomly co"er
all ,ser &oints in a 'ee*. <Sam&ling &lan mentioned in 5.:>. W%en t%e t%ird &%ase is com&leted
data s%all be collected
Page A8 of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: !ffecti"e Date:
/fter P%ase5# routine monitoring sc%edule s%all be fro-en.
De'((!(o:
S*m#-(, #o(!%: /ll t%e sam&le collection &oints of &re5treatment <2G( ? Softener> and
generation system of &urified 'ater </0( ? ,( ? G. ? !D+ > &rior to Distribution loo& systems
termed as sam&ling &oints.
U%*,e #o(!%: /ll t%e sam&ling &oints on distribution loo& systems for .ral Solid bloc* and
.ral Ii)uid, Q0 bloc* are termed as ,sage &oints.
6"1 Re9u($e& W*!e$ S#ec('(c*!(o%
6"1". S#ec('(c*!(o o' R*+ W*!e$:
S"
No"
Te%! P*$*me!e$ S#ec('(c*!(o STP co&e
A. Descri&tion
0lear colourless, odourless and
tasteless li)uid
2. &4 Eet'een 5.D to ;.D
#. $otal Dissol"ed Solids $o record results
4. 4ardness $o record results
5. 0%lorides $o record results
8. Sul&%ates $o record results
:. $otal 2icrobial 0ount N2$ 5DD cfu 3 ml
;.
Pat%ogens
a) Escherichia coli
b) Salmonella
c) Pseudomonas
aerugonisa
d) Staphylococcus
aureus
S%ould be absent
S%ould be absent
S%ould be absent
S%ould be absent
=. !nterobacteriaceae S%ould be absent
6"1"1 S#ec('(c*!(o o' Po!*3-e W*!e$:
S"
No"
Te%! P*$*me!e$ S#ec('(c*!(o STP co&e
A. Descri&tion
0lear colourless, odourless and
tasteless li)uid
2. $otal 2icrobial 0ount N2$ 5DD cfu 3 ml
#. Pat%ogens
a) Escherichia coli S%ould be absent
Page A: of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: !ffecti"e Date:
b) Salmonella
c) Pseudomonas
aerugonisa
d) Staphylococcus
aureus
S%ould be absent
S%ould be absent
S%ould be absent
4. !nterobacteriaceae S%ould be absent
Page A; of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: !ffecti"e Date:
6"1"0 S#ec('(c*!(o o' So'! W*!e$:
S"
No"
Te%! P*$*me!e$ S#ec('(c*!(o STP co&e
A. Descri&tion
0lear colourless, odourless and
tasteless li)uid
2. &4 Eet'een 5.D to ;.D
#. $otal Dissol"ed Solids $o record results
4. 4ardness $o record results
5. $otal 2icrobial 0ount N2$ 5DD cfu 3 ml
8.
Pat%ogens
a) Escherichia coli
b) Salmonella
c) Pseudomonas
aerugonisa
d) Staphylococcus
aureus
S%ould be absent
S%ould be absent
S%ould be absent
S%ould be absent
6"1"2 S#ec('(c*!(o o' RO !$e*!e& W*!e$:
S"
No"
Te%! P*$*me!e$ S#ec('(c*!(o STP co&e
A. Descri&tion
0lear colourless, odourless and
tasteless li)uid
2. &4 Eet'een 5.D to :.5
#. 0alcium and 2agnesium / &ure blue colour is &roduced
4. 4ea"y 2etals 0om&ly as &er +.P.
5. $otal 2icrobial 0ount N2$ ADD cfu 3 ml
8.
Pat%ogens
a) Escherichia coli
b) Salmonella
c) Pseudomonas
aerugonisa
d) Staphylococcus
aureus
S%ould be absent
S%ould be absent
S%ould be absent
S%ould be absent
Page A= of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: !ffecti"e Date:
6"1"6 S#ec('(c*!(o o' Pu$('(e& W*!e$:
S"
No"
Te%! P*$*me!e$ S#ec('(c*!(o STP co&e
A. Descri&tion
0lear, colourless, odourless and
tasteless li)uid.
2. &4 Eet'een 5.D to :.D
#. 0%lorides
$%e solution does not s%o' any
c%ange in a&&earance at least after
A5 minutes.
4. Sul&%ates
$%e solution does not s%o' any
c%ange in a&&earance at least after
A %our.
5. Nitrates 0om&ly as &er +.P.
8. /mmonium
$est solution is not more intensely
coloured t%an standard solution.
:. 0alcium 92agnesium Pure blue colour is &roduced.
;. 4ea"y 2etals 0om&ly as &er +.P.
=. Gesidue on !"a&oration Not more t%an D.DDAH
AD. /cidity or /l*alinity
$%e solution is not red and blue
coloured.
AA. 0onducti"ity Not more t%an 2.A s3 cm at 25C0
A2. .1idisable substances $%e solution remains faintly &in*.
A#. $otal .rganic 0arbon Not more t%an 5DD &&b
A4. $otal 2icrobial 0ount Not more t%an ADD cfu 3 ml
A5.
Pat%ogens
a) Escherichia coli
b) Salmonella
c) Pseudomonas
aerugonisa
d) Staphylococcus
aureus
S%ould be absent
S%ould be absent
S%ould be absent
S%ould be absent
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
Page 2D of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution System
Protocol No.: !ffecti"e Date:
6"0 Te%! S#ec('(c*!(o, S*m#-(, P-* < F$e9uec5
S"
No"
N*me o' !@e S*m#-(, #o(! S#ec('(c*!(o
Com#-(*ce
S*m#-(,
#o(! No"
Room No" P@*%e 8 .
S*m#-(,
'$e9uec5
P@*%e 8 1
S*m#-(,
'$e9uec5
P@*%e 8 0
S*m#-(,
'$e9uec5 A
D*5
A
S*m#-(, #o(!% ( P$eD!$e*!me! %5%!em
A. Ga' 'ater inlet Ga' Water SPDDA N/
Daily
Wee*ly Wee*ly
2.
+nlet of 2ulti grade (ilter
Ga' Water
SPDD2
N/ N/ N/
#.
.utlet of 2ulti grade (ilter
Potable Water
SPDD#
N/ N/ N/
4.
.utlet of Softener Plant ? A
Soft 'ater
SPDD4
N/ N/ N/
5.
.utlet of Softener Plant 5 2 SPDD5
N/ N/ N/
8.
.utlet of Soft 'ater Storage tan*
SPDD8 / 3 E 3
0 3 D
N/ N/ N/
B S*m#-(, #o(!% ( Gee$*!(o %5%!em
:. +nlet of /cti"ated 0arbon (ilter
Soft 'ater
SPDD: N/
Daily
Wee*ly Wee*ly
;.
.utlet of /cti"ated 0arbon (ilter SPDD;
N/ Wee*ly Wee*ly
=. +nlet of 2icron 0artridge (ilter SPDD= N/ N/ N/
AD. .ut let of 2icron 0artridge (ilter SPDAD N/ N/ N/
AA.
.utlet of ,ltra "iolet system <Eefore ,(> SPDAA
N/ Wee*ly Wee*ly
A2.
.utlet of ,ltra (iltration System SPDA2
N/ Wee*ly Wee*ly
A#.
.ut let of Storage $an* SPDA#
N/ N/ N/
A4.
.utlet of /nti scalant dosing system SPDA4
N/ N/ N/
A5.
.utlet of &4 correction dosing system SPDA5
N/ N/ N/
A8.
.ut let of 2icron 0artridge (ilter SPDA8
N/ N/ N/
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
Page 2A of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution System
Protocol No.: !ffecti"e Date:
S"
No"
N*me o' !@e S*m#-(, #o(! S#ec('(c*!(o
Com#-(*ce
S*m#-(, #o(!
No"
Room No" P@*%e 8 .
S*m#-(,
'$e9uec5
P@*%e 8 1
S*m#-(,
'$e9uec5
P@*%e 8 0
S*m#-(,
'$e9uec5 A
D*5
A:. .utlet of S2ES dosing system Soft 'ater SPDA: N/
Daily
N/ N/
A;. Permeate of G. 2odule 5 A G. $reated
'ater
SPDA;
N/ Wee*ly Wee*ly
A=.
Permeate of G. 2odule 5 2 SPDA=
N/ Wee*ly Wee*ly
2D. Permeate of !D+ 5 A G. $reated
'ater
SPD2D
N/ Wee*ly Wee*ly
2A. Permeate of !D+ 5 2
SPD2A
N/ Wee*ly Wee*ly
22. .utlet of ,ltra 7iolet System </fter !D+> Purified Water
SPD22
N/ N/ N/
C S*m#-(, #o(!%AU%*,e #o(!% ( D(%!$(3u!(o -oo# %5%!em 'o$ O$*- %o-(&% 3-ocB
2#. .utlet of Pum&
Purified Water
SPD2# N/
Daily Daily
2onday
24.
.utlet of ,ltra 7iolet System
SPD24
N/
$uesday
25. Geturn loo& of distribution system for .ral solids SPD25 N/
Wednesday
28. Ein Was% 1111 $ ? D2 2onday
2:. /rea5A 1111 $ ? 2# 2onday
2;. /rea2
1111
$ ? 2#/ 2onday
2=. /rea5# 1111 $ ? 28 $uesday
#D. /rea54 1111 $ ? 28/ $uesday
#A. /rea55 1111 $ ? #D $uesday
#2. /rea58
1111
$ ? #D/
Wednesday
##. /rea5:
1111
$ ? #8
Wednesday
#4. /rea5;
1111
$ ? #8/
Wednesday
#5. /rea5=
1111
$ ? 4A $%ursday
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
Page 22 of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution System
Protocol No.: !ffecti"e Date:
S"
No"
N*me o' !@e S*m#-(, #o(! S#ec('(c*!(o
Com#-(*ce
S*m#-(,
#o(! No"
Room No" P@*%e 8 .
S*m#-(,
'$e9uec5
P@*%e 8 1
S*m#-(,
'$e9uec5
P@*%e 8 0
S*m#-(,
'$e9uec5 A
D*5
#8. /rea AD
Purified Water
1111
$ ? 4A/
Daily Daily
$%ursday
#:. AA
1111
$ ? 4;
$%ursday
#;. A2 1111 $ ? 4= $%ursday
#=. A# 1111 $ ? 52 (riday
4D. A4
1111
$ ? 52/
(riday
4A. A5
1111
$ ? =D
(riday
42. A8
1111
$ ? =A
(riday
4#. A:
1111
$ ? =2 Saturday
44. A;
1111
$ ? =; Saturday
45. A=
1111
SG ? 2; 2onday
48. 2D
1111
SG ? 28 $uesday
4:. 2A
1111
SG ? 2: Wednesday
4;. 22
1111
SG ? 22 $%ursday
4=. 2#
1111 N/
(riday
5D.
1111 N/
Saturday
D S*m#-(, #o(!% AU%*,e #o(!% ( D(%!$(3u!(o Loo# S5%!em 'o$ L(9u(& O$*- *& QC B-ocB
5A. .utlet of Pum&
Purified Water
1111 N/
Daily Daily
2onday
52. .utlet of ,ltra 7iolet System 1111 N/ $uesday
5#.
Geturn loo& of distribution system for
Ii)uid .ral and Q0 Eloc*
1111 N/
Wednesday
54. Was%
1111
I ? D5 2onday
55. Syru& 2fg.
1111
I ? AD 2onday
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
Page 2# of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution System
Protocol No.: !ffecti"e Date:
S"
No"
N*me o' !@e S*m#-(, #o(! S#ec('(c*!(o
Com#-(*ce
S*m#-(,
#o(! No"
Room No" P@*%e 8 .
S*m#-(,
'$e9uec5
P@*%e 8 1
S*m#-(,
'$e9uec5
P@*%e 8 0
S*m#-(,
'$e9uec5 A
D*5
58. Was%
Purified Water
1111 I ? A#
Daily Daily
2onday
5:. Pre&aration
1111
I ? A: 2onday
5;. Pre&aration
1111
I ? A:
$uesday
5=. Pre&aration
1111
I ? A=
$uesday
8D. Pre&aration
1111
I ? A=
$uesday
8A.
2fg. ? # 1111
I ? 2A
$uesday
82.
2fg. ? # 1111
I ? 2A Wednesday
8#. Was%
1111
I ? 22
Wednesday
84. 2fg. ? 2
1111
I ? 24
Wednesday
85. 2fg. ? 2
1111
I ? 24
Wednesday
88. 2fg.
1111
I ? 2: $%ursday
8:. Was%
1111
I ? 2;
$%ursday
8;. 4old
1111
I ? 2=
$%ursday
8=. 4old
1111
I ? 2=
$%ursday
:D. (ill 3 Seal
1111
I ? #= (riday
:A. (ill 3 Seal
1111
I ? 4#
(riday
:2.
(ill 3 Seal line ? # 1111
I ? 4;
(riday
:#. (ill 3 Seal line ? 2
1111
I ? 52
(riday
:4. (ill 3 Seal line ? A
1111
I ? 58 Saturday
:5. Q0 Was% room
1111 N/ Saturday
:8. 2icrobiology Iab
1111 N/ Saturday
::. 2icrobiology Iab
1111 N/ Saturday
xxxxxxxxxxxxxxxx
Page 24 of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: 1111111111111 !ffecti"e Date:
6"2 Re9u($e& SOP=%
$%e 'ater system o&eration 'ill be carried out as &er gi"en S.Ps:
a> .&eration of Water System <S.P No.: NNNNNNN>.
b> Pre&aration of Sodium %y&oc%lorite solution <S.P No.: NNNNNNN>.
c> Pre&aration of /nti5scalant solution <S.P No.: NNNNNNN>.
d> 0leaning of 0artridge filters <S.P No.: NNNNNNN>.
e> 0leaning of ,7 &urifier and re&lacement of ,7 lam&s <S.P No.: NNNNNNN>.
f> Gegeneration &rocedure for Softener <S.P No.: NNNNNNN>.
g> Saniti-ation Procedure on Distribution loo& system <S.P No.: NNNNNNN>.
$%e &rogram in"ol"es intensi"e daily sam&ling and testing of ma6or &rocess &oints at JNormal
.&erating 0onditions.K
+n t%e &rocess, regeneration, saniti-ation &rocedure and storage &eriod of 'ater in t%e
storage tan* s%all be establis%ed.
xxxxxxxxxxxxxxxx
Page 25 of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: 1111111111111 !ffecti"e Date:
6"6 E)*-u*!(o o' Re%u-!%
P@*%e D . Re%u-!
/fter com&letion of P%ase5+, /lert and /ction limits of testing &arameters for &urified 'ater 'ill
be calculated as &er gi"en e)uation and t%ese alert and action limits 'ill be follo'ed for furt%er
)ualification of 'ater system.
A-e$! -e)e-% are le"els or range t%at, '%en e1ceededO indicate t%at a &rocess may %a"e drifted
from its normal o&erating condition.
/lert le"els constitute a 'arning and do not necessarily re)uire a correcti"e action.
J/lert Ie"el P /"erage F 2 Standard De"iationK
/ction le"els are le"els or range t%at, '%en e1ceeded, indicate t%at a &rocess %as drifted from its
normal o&erating range. !1ceeding an /ction le"el indicates t%at correcti"e action s%ould be
ta*en to bring t%e &rocess bac* into its normal o&erating range>.
J/ction Ie"el P /"erage F # Standard De"iationK
Eased on t%e Study of Drain time, conclusion 'ill be dra'n for t%e &eriod of drainage of
Purified Water before usage during &rocess.
Eased on 4old $ime study, conclusion 'ill be dra'n for Purified Water storage &eriod in
case it is re)uired.
P@*%e 8 1 Re%u-!%
/fter successful com&letion of P%ase ? 2, fre)uency of regeneration, saniti-ation o&eration s%all
be finali-ed. $%e fre)uency obtained during P%ase ? 2 studies s%all be follo'ed in P%ase ? #.
P@*%e 8 0 Re%u-!%
/fter successful com&letion of P%ase ? #, data obtained during t%e &rocess s%all be com&iled and
conclusion s%all be dra'n considering t%e Seasonal "ariation factor. $%ereafter Purified Water
Generation Storage and Distribution System s%all be released for regular usage.
xxxxxxxxxxxxxxxx
Page 28 of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: 1111111111111 !ffecti"e Date:
6.0Pe$'o$m*ce Qu*-('(c*!(o P$oce&u$e
$%e follo'ing &rocedure s%all be used for &erformance )ualification of &urified 'ater
generation, storage and distribution system:
8.A !nsure t%at 'ater system %as )ualified for o&erational )ualification.
8.2 Saniti-ation s%all be &erformed as &er res&ecti"e S.P. $%e obser"ation of t%e study s%all be
recorded as &er t%e format &ro"ided in !1%ibit5DA. $%e data s%eets s%all be attac%ed date
'ise in /nne1ure5DA.
8.# $%e &%ase5A studies s%all be done as &er &oint no.5.5. $%e obser"ations of t%e study s%all be
recorded as &er t%e format &ro"ided in !1%ibit5D2 to !1%ibit5D;. $%e data s%eets s%all be
attac%ed date 'ise in /nne1ure5D2. /fter com&letion of &%ase5+ studies t%e gra&%ical
re&resentation of t%e data of all t%e &arameters s%all be done indi"idually and attac%ed in
/nne1ure5D#.
8.4 $%e &%ase52 studies s%all be done as &er &oint no.5.8. $%e obser"ations of t%e study s%all be
recorded as &er t%e format &ro"ided in !1%ibit5D2 to !1%ibit5D8. $%e data s%eets s%all be
attac%ed date 'ise in /nne1ure5D4. /fter com&letion of &%ase52 studies t%e gra&%ical
re&resentation of t%e data of all t%e &arameters s%all be done indi"idually and attac%ed in
/nne1ure5D5.
8.5 $%e &%ase5# studies s%all be done as &er &oint no.5.:. $%e obser"ations of t%e study s%all be
recorded as &er t%e format &ro"ided in !1%ibit5D2 to !1%ibit5D8. $%e data s%eets s%all be
attac%ed date 'ise in /nne1ure5D8. /fter com&letion of &%ase5A studies t%e gra&%ical
re&resentation of t%e data of all t%e &arameters s%all be done indi"idually and attac%ed in
/nne1ure5D:.
8.8 /ny de"iation obser"ed in &erformance )ualification s%all be recorded as obser"ed de"iation,
correcti"e action and 6ustification re&ort.
8.: .bser"ed de"iation s%all be re&orted to t%e Quality control 5 4ead and Quality /ssurance ?
4ead.
8.; +f t%e obser"ed de"iation does not %a"e any ma6or im&act on t%e )ualification t%e final
conclusion s%all be &ro"ided.
8.= +f t%e obser"ed de"iation %as ma6or im&act on t%e )ualification, de"iation s%all be re&orted to
t%e manufacturer for t%e correcti"e action and )ualification acti"ity s%all be redone.
xxxxxxxxxxxxxxxx
Page 2: of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: 1111111111111 !ffecti"e Date:
7.0Acce#!*ce C$(!e$(*
Performance )ualification s%all be considered acce&table '%en re)uirements listed in section 8.D
of t%is &rotocol %a"e been fulfilled and all t%e com&onents of
&urified 'ater generation, storage and distribution system are &erformed as &er t%e design
s&ecifications and as &er manufacturer recommendations.
8.0Qu*-('(c*!(o Re#o$!
$%e &erformance )ualification re&ort s%all consist of a summary document, in
narrati"e form, '%ic% s%all briefly describe t%e acti"ity &erformed along 'it% t%e obser"ations
recorded in rele"ant e1%ibits.
$%is re&ort s%all also include t%e related documents and attac%ments 3 anne1ure '%ic%
'ere com&leted at t%e time of )ualification acti"ity.
9.0A##$o)*- o' Qu*-('(c*!(o Re#o$!
$%e re&ort s%all be e"aluated and &ro&er references 3 conclusions 3 recommendations s%all be
recorded by Quality /ssurance.
$%e &erformance )ualification re&ort s%all be e"aluated and finally a&&ro"ed by )uality
assurance.
xxxxxxxxxxxxxxx
Page 2; of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution System
Protocol No.: 1111111111 !ffecti"e Date:
10.0O3%e$)e& De)(*!(o
S$"
No"
P*,e
No"
Po(!
No"
O3%e$)e& De)(*!(o De)(*!(o
Re#o$!e&
B5
De)(*!(o
A##$o)e&
B5
Co$$ec!()e Ac!(o T*Be Gu%!('(c*!(o o' Co$$ec!()e
Ac!(o
Co$$ec!()e *c!(o
!*Be *&
4u%!('(c*!(o ,()e 35
Re#o$! A##$o)e& B5
De#*$!me! Ce*& Qu*-(!5 Ce*&
Page 2= of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: 111111111 !ffecti"e Date:
11.0L(%! o' E?@(3(!% A Ae?u$e
..". L(%! o' E?@(3(!%
E?@(3(! No" E?@(3(! T(!-e No" o' P*,e%
DA Data s%eet for PQ test results of Ga' 'ater
D2 Data s%eet for PQ test results of Potable 'ater
D# Data s%eet for PQ test results of Soft 'ater
D4 Data s%eet for PQ test results of G. 'ater
D5 Data s%eet for PQ test results of Purified 'ater
D8 Data S%eet for Study t%e Gegeneration and
Saniti-ation sc%edule of Pre5treatment, Generation
and Distribution System by monitoring 2icrobial
Data
D: Data S%eet for Drain $ime Study $est Gesults of
Purified Water
D; Data S%eet for 4old $ime Study $est Gesults of
Purified Water
.."1 L(%! o' Ae?u$e%
Ae?u$e No" Ae?u$e T(!-e No" o' P*,e%
DA Gecord for Saniti-ation
D2 Data s%eets of P%ase5+
D# Gra&%ical re&resentation of P%ase5+ results
D4 Data s%eets of P%ase5++
D5 Gra&%ical re&resentation of P%ase5++ results
D8 Data s%eets of P%ase5+++
D: Gra&%ical re&resentation of P%ase5+++ results
D; Ge&ort for Performance Qualification of Water
system
12.0Re'e$ece Docume!%
12.1Design Qualification <Doc No.: D+!0+I ? 82 ? QD2 ? DD>.
Page #D of 54
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: 111111111 !ffecti"e Date:
12.2+nstallation Qualification < >
12.3.&eration Qualification < >
12.4,nited States P%armaco&oeia <,SP2=>.
12.5+ndian P%aramco&oeia <+PA==8>.
xxxxxxxxxxx
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: 111111111111111 !ffecti"e Date:
E?@(3(! 8 E/.
D*!* S@ee! 'o$ S!u&5 !@e Re,ee$*!(o *& S*(!(F*!(o %c@e&u-e o' P$eD!$e*!me!, Gee$*!(o
*& D(%!$(3u!(o S5%!em 35 mo(!o$(, M(c$o3(*- D*!*
System Name:
$ag No.:
Sam&ling Point No.:
P%ase:
D*!e M(c$o3(*- Lo*& Re,ee$*!(oA
S*(!(F*!(o
D*!e
M(c$o3(*- Lo*&
To!*- M(c$o3(*-
Cou!
P*!@o,e% To!*- M(c$o3(*-
Cou!
P*!@o,e%
Sam&led Ey : NNNNNNNNNNNNN
/nalysed Ey : NNNNNNNNNNNNN
0%ec*ed Ey : NNNNNNNNNNNNN
!1%ibit !DA: Page A of A
xxxxxxxxxxx
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: 111111111111111 !ffecti"e Date:
E?@(3(! 8 E/1
D*!* S@ee! 'o$ PQ Te%! Re%u-!% o' R*+ W*!e$
System Name:
$ag No.:
Sam&ling Point No.:
P%ase:
D*!e ()
Te%! P*$*me!e$% () Re%u-!%
Descri&tion
&4
$otal Dissol"ed Solids
4ardness
0%lorides
Sul&%ates
$otal 2icrobial 0ount
P
a
t
%
o
g
e
n
s
Escherichia coli
Salmonella
Pseudomonas
aeruginosa
Staphylococcus
aureus
S
a
m
&
l
e
d

E
y
0%emical
/nalysis
2icrobiological
/nalysis
/
n
a
l
y
s
e
d

E
y
0%emical
/nalysis
2icrobiological
/nalysis
0%ec*ed Ey
/&&ro"ed Ey:
Date:
!1%ibit !D2: Page A of A
xxxxxxxxxxx
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: 111111111111111 !ffecti"e Date:
E?@(3(! 8 E/0
D*!* S@ee! 'o$ PQ Te%! Re%u-!% o' Po!*3-e W*!e$
System Name:
$ag No.:
Sam&ling Point No.:
P%ase:

D*!e ()
Te%! P*$*me!e$% () Re%u-!%
Descri&tion
$otal 2icrobial 0ount
P
a
t
%
o
g
e
n
s
Escherichia coli
Salmonella
Pseudomonas
aeruginosa
Staphylococcus
aureus
!nterobacteriaceae
S
a
m
&
l
e
d

E
y
0%emical
/nalysis
2icrobiological
/nalysis
/
n
a
l
y
s
e
d

E
y
0%emical
/nalysis
2icrobiological
/nalysis
0%ec*ed Ey
/&&ro"ed Ey:
Date:
!1%ibit !D#: Page A of A
xxxxxxxxxxx
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: 111111111111111 !ffecti"e Date:
E?@(3(! 8 E/2
D*!* S@ee! 'o$ PQ Te%! Re%u-!% o' So'! W*!e$
System Name:
$ag No.:
Sam&ling Point No.:
P%ase:
D*!e ()
Te%! P*$*me!e$% () Re%u-!%
Descri&tion
&4
$otal Dissol"ed Solids
4ardness
$otal 2icrobial 0ount
P
a
t
%
o
g
e
n
s
Escherichia coli
Salmonella
Pseudomonas
aeruginosa
Staphylococcus
aureus
S
a
m
&
l
e
d

E
y
0%emical
/nalysis
2icrobiological
/nalysis
/
n
a
l
y
s
e
d

E
y
0%emical
/nalysis
2icrobiological
/nalysis
0%ec*ed Ey
/&&ro"ed Ey:
Date:
!1%ibit !D4: Page A of A
xxxxxxxxxxx
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: 111111111111111 !ffecti"e Date:
E?@(3(! 8 E/6
D*!* S@ee! 'o$ PQ Te%! Re%u-!% o' RO T$e*!e& W*!e$
System Name:
$ag No.:
Sam&ling Point No.:
P%ase:
D*!e ()
Te%! P*$*me!e$% () Re%u-!%
Descri&tion
&4
0alcium 9 2agnesium
Nitrates
4ea"y 2etals
$otal 2icrobial 0ount
P
a
t
%
o
g
e
n
s
Escherichia coli
Salmonella
Pseudomonas
aeruginosa
Staphylococcus
aureus
S
a
m
&
l
e
d

E
y
0%emical /nalysis
2icrobiological
/nalysis
/
n
a
l
y
s
e
d

E
y
0%emical /nalysis
2icrobiological
/nalysis
0%ec*ed Ey
/&&ro"ed Ey:
Date:
!1%ibit !D5: Page A of A
xxxxxxxxxxx
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: 111111111111111 !ffecti"e Date:
E?@(3(! 8 E/7
D*!* S@ee! 'o$ PQ Te%! Re%u-!% o' Pu$('(e& W*!e$
System Name:
$ag No.:
Sam&ling Point No.:
P%ase:
D*!e ()
Te%! P*$*me!e$% () Re%u-!%
Descri&tion
&4
Sul&%ates
Nitrates
0%lorides
/mmonium
0alcium 9 2agnesium
4ea"y 2etals
Gesidue on !"a&oration
/cidity or /l*alinity
0onducti"ity
.1idisable substances
$otal .rganic 0arbon
$otal 2icrobial 0ount
P
a
t
%
o
g
e
n
s
Escherichia coli
Salmonella
Pseudomonas
aeruginosa
Staphylococcus
aureus
S
a
m
&
l
e
d

E
y
0%emical
/nalysis
2icrobiological
/nalysis
/
n
a
l
y
s
e
d

E
y
0%emical
/nalysis
2icrobiological
/nalysis
0%ec*ed Ey
/&&ro"ed Ey:
Date:
!1%ibit !D8: Page A of A
xxxxxxxxxxx
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: 111111111111111 !ffecti"e Date:
E?@(3(! 8 E/:
D*!* S@ee! 'o$ D$*( T(me S!u&5 Te%! Re%u-!% o' Pu$('(e& W*!e$
System Name:
$ag No.:
Sam&ling Point No.:
P%ase:
!1%ibit !D:: Page A of A
WeeB ()
D*!e ()
T(me () Re%u-!%
Te%! #*$*me!e$%
()
$otal
2icrobial
0ount
Pat%ogen $otal
2icrobial
0ount
Pat%ogen $otal
2icrobial
0ount
Pat%ogen
/ m(u!e%
6 m(u!e%
./ m(u!e%
Sam&led Ey
/nalysed Ey
0%ec*ed Ey
xxxxxxxxxxx
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: 111111111111111 !ffecti"e Date:
E?@(3(! 8 E/;
D*!* S@ee! 'o$ Co-& T(me S!u&5 Te%! Re%u-!% o' Pu$('(e& W*!e$
System Name:
$ag No.:
Sam&ling Point No.:
P%ase:
!1%ibit !D;: Page A of A
WeeB ()
D*!e ()
T(me () Re%u-!%
Te%! #*$*me!e$%
()
$otal
2icrobial
0ount
Pat%ogen $otal
2icrobial
0ount
Pat%ogen $otal
2icrobial
0ount
Pat%ogen
/ @$
. @$
0 @$
6 @$
; @$
.1 @$
Sam&led Ey
/nalysed Ey
0%ec*ed Ey
xxxxxxxxxxx
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: 111111111111111 !ffecti"e Date:

Ae?u$e 8 /.
Reco$& 'o$ S*(!(F*!(o
E9u(#me! N*me: Purified 'ater generation, storage
and distribution system
E9u(#me! T*, No":
Loc*!(o: 111111111111
No" o' P*,e%:
xxxxxxxxxxx
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: 111111111111111 !ffecti"e Date:
Ae?u$e 8 /1
D*!* S@ee!% o' P@*%eDI
E9u(#me! N*me: Purified 'ater generation, storage
and distribution system
E9u(#me! T*, No":
Loc*!(o: 1111111111
No" o' P*,e%:
xxxxxxxxxxx
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: 111111111111111 !ffecti"e Date:
Ae?u$e 8 /0
G$*#@(c*- Re#$e%e!*!(o o' P@*%eDI Re%u-!%
E9u(#me! N*me: Purified 'ater generation, storage
and distribution system
E9u(#me! T*, No":
Loc*!(o: 1111111111
No" o' P*,e%:
xxxxxxxxxxx
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: 111111111111111 !ffecti"e Date:
Ae?u$e 8 /2
D*!* S@ee!% o' P@*%eDII
E9u(#me! N*me: Purified 'ater generation, storage
and distribution system
E9u(#me! T*, No":
Loc*!(o: 11111111111
No" o' P*,e%:
xxxxxxxxxxx
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: 111111111111111 !ffecti"e Date:
Ae?u$e 8 /6
G$*#@(c*- Re#$e%e!*!(o o' P@*%eDII Re%u-!%
E9u(#me! N*me: Purified 'ater generation, storage
and distribution system
E9u(#me! T*, No":
Loc*!(o: 11111111111
No" o' P*,e%:
xxxxxxxxxxx
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: 111111111111111 !ffecti"e Date:
Ae?u$e 8 /7
D*!* S@ee!% o' P@*%eDIII
E9u(#me! N*me: Purified 'ater generation, storage
and distribution system
E9u(#me! T*, No":
Loc*!(o: 11111111111111
No" o' P*,e%:
xxxxxxxxxxx
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: 111111111111111 !ffecti"e Date:
Ae?u$e 8 /:
G$*#@(c*- Re#$e%e!*!(o o' P@*%eDIII Re%u-!%
E9u(#me! N*me: Purified 'ater generation, storage
and distribution system
E9u(#me! T*, No":
Loc*!(o: 111111111
No" o' P*,e%:
xxxxxxxxxxx
T(!-e: Protocol for Performance Qualification of Purified Water Generation, Storage and Distribution
System
Protocol No.: 111111111111111 !ffecti"e Date:
Ae?u$e 8 /;
Re#o$! 'o$ Pe$'o$m*ce Qu*-('(c*!(o o'
W*!e$ %5%!em
E9u(#me! N*me: Purified 'ater generation, storage
and distribution system
E9u(#me! T*, No":
Loc*!(o: 111111111111111
No" o' P*,e%: