VALIDATION PROTOCOL FOR PURIFIED WATER SYSTEM Document No.
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CONCURRENT VALIDATION PROTOCOL FOR PURIFIED WATER SYSTEM (Identifi!tion No" /DM/01#
AT
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VALIDATION PROTOCOL FOR PURIFIED WATER SYSTEM Document No.
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TITLE OF CONTENTS S"NO
TITLE
1.0
Objective
2.0
Scope
3.0
Responsibility
.0
!ac" g#oun$
%.0
Int&od'tion %.1 &ocations %.2 '#e(uency %.3 )cceptance c#ite#ia
*.0
P&oed'&e *.1
+ene#al aspects of vali$ation p#og#am
*.2
!#ief $esc#iption of t,e -ajo# components of t,e ate# system Sc,ematic #ep#esentation of /ate# system
6.3
Annexure - I 6.4
Sc,ematic #ep#esentation of /ate# system In$icating Sampling points Annexure - II
*.%
Sampling locations est plan an$ f#e(uency
*.*
est plan an$ )cceptance c#ite#ia
*.
P#esentation of vali$ation #esults
*.
4valuation of $ata an$ p#epa#ation of summa#y #epo#t
*.5
6onclusions an$ Recommen$ations
*.10 6,ange cont#ol
1"0
O)ECTIVE*
PA%E No"
VALIDATION PROTOCOL FOR PURIFIED WATER SYSTEM Document No.
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1.1 ,is p#otocol $esc#ibes t,e p#oce$u#e fo# vali$ating t,e enti#e ate# system to ensu#e t,e
pe#fo#mance of t,e $iffe#ent sub7systems involve$ in t,e ate# t#eatment an$
to assu#e t,e 8uality of ate#.
$"0
SCOPE* 2.1 ,e Scope of t,is P#otocol is applicable to t,e /ate# System of t,e -anufactu#ing 'acility of Pegasus 'a#maco In$ia Pvt.&t$. 25 ID) !,ongi# Nalgon$a Dist.
+"0 RESPONSIILITY 3.1 It is a joint #esponsibility of 4nginee#ing Depa#tment P#o$uction Depa#tment 8uality cont#ol an$ 8uality )ssu#ance Depa#tment. ,e $etaile$ Responsibility mat#i9 is $esc#ibe$ in ne9t page. RESPONSIILITY MATRI,
1
PROO6O& PR4P)R)ION
2
PROO6O& R4;I4/
3
PROO6O& 4<46=ION
%
*
6:4-IS786
-)N)+4R 786 IN6:)R+4 7 P&)N > -)N)+4R PROD=6ION
S)-P&IN+ > 4SIN+ )S P4R
4<46=I;4786
PROO6O&
-I6RO7!IO&O+IS786
D)) 6O-PI&)ION )ND R4POR PR4P)R)ION
-)N)+4R 786
PROO6O& )PPRO;)& S=--)R? R4POR )PPRO;)&
4"0 AC- %ROUND
-)N)+4R78)
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/ate# is most commonly use$ in p,a#maceutical manufactu#ing. It is use$ in t,e manufactu#ing of $osage fo#ms cleaning of manufactu#ing e(uipment etc.
4"$
,e (uality att#ibutes of ate# can va#y seasonally it,out a#ning. /ate# t#eatment systems a#e ,ig,ly $ynamic an$ un#eliable to some $eg#ee. :ence t,ey must be vali$ate$ an$ closely monito#e$ an$ cont#olle$.
."0 INTRODUCTION ."1
LOCATIONS Sampling points a#e selecte$ at p#e$efine$ locations so as to monito# an$ assess t,e
effectiveness
of
eac,
majo#
system
component.
6,emical
an$
mic#obiological (uality is teste$ as applicable an$ assesse$. ,e $etaile$ locations of sampling points a#e sc,ematically #ep#esente$ an$ specifie$ in t,is p#otocol. ."$
FREUENCY ,e enti#e vali$ation p#og#amme is sub7$ivi$e$ in to t,#ee p,ases " ."$"1
P!e2I tetin3 %.2.1.1 ) test pe#io$ of 2 7 ee"s is planne$ fo# monito#ing t,e system intensively. Du#ing t,is pe#io$ t,e system s,oul$ ope#ate continuously it,out failu#e o# pe#fo#mance $eviation. ,e test plan $etails a#e p#ovi$e$ at step *.%.
."$"$
P!e2II tetin3 %.2.2.1 )
test pe#io$ of 2 ee"s
is use$ fo# ca##ying out fu#t,e#
intensive monito#ing afte# t,e satisfacto#y completion of p,ase 1. /ate# can be use$ fo# manufactu#ing pu#poses $u#ing t,is p,ase. ,e app#oac, s,oul$ $emonst#ate consistent ope#ation it,in establis,e$ #anges.
."$"+
P!e III
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%.2.3.1 P,ase 3 #uns fo# 1 yea# afte# t,e satisfacto#y completion of p,ase 2.,e main objective of
t,e stu$y
is to
$emonst#ate
e9ten$e$ #eliable pe#fo#mance. )n$ ensu#e t,at seasonal va#iations a#e evaluate$.
,e sample locations sampling
f#e(uencies an$ tests a#e #e$uce$ to t,e no#mal #outine patte#n. ."+ ACCEPTANCE CRITERIA ."+"1
/,ile f#aming acceptance c#ite#ia t,e $esign pa#amete#s of t,e majo# components of t,e ate# systems is "ept in min$. .. )cceptance c#ite#ia fo# t,e Pu#ifie$ ate# ,as been establis,e$ ta"ing into consi$e#ation t,e p,a#macopeial limits fo# Pu#ifie$ ate#
5"0 PROCEDURE ,e ;ali$ation )pp#oac, Diffe#ent Sampling an$ esting Plan )cceptance 6#ite#ia an$ ;ali$ation )ssessment a#e $etaile$ un$e# t,e folloing sub sections of t,is p#otocol *.1 +ene#al aspects of vali$ation p#og#am *.2 !#ief $esc#iption of t,e majo# components of t,e ate# system *.3 Sc,ematic #ep#esentation of D- unit in$icating sampling points *. Sc,ematic #ep#esentation of Reci#culation loop system in$icating sampling points *.% Sampling locations test plan an$ f#e(uency *.* est plan an$ acceptance c#ite#ia *. P#esentation of vali$ation #esults *. 4valuation of $ata an$ p#epa#ation of summa#y #epo#t *.5 6onclusions an$ #ecommen$ations *.10
5"1
6,ange cont#ol
%ene&!6 A7et of V!6id!tion P&o3&!8
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,e basic vali$ation st#ategy is to maintain t,e system un$e# no#mal ope#ating con$itions $u#ing ,ic, f#e(uent an$ e9tensive sampling an$ testing is ta"en up in7o#$e# to assess t,e ate# system
5"1"$
Installation 8ualification @I8A
p#otocol ensu#es all t,e #e(ui#ements to
ve#ify t,e installation of t,e components of t,e ate# system as pe# t,e #e(ui#ement. Ope#ational (ualification @O8A p#otocol specifies an$ ensu#es t,e functioning of $iffe#ent components as pe# t,e manufactu#e# manual. Du#ing t,e vali$ation consistency of t,e pe#fo#mance of t,e system ove# seve#al mont,s of time is assesse$. 5"1"+
O7e&!tin3 7&oed'&e !nd 9e: ont&o6 7!&!8ete& *.1.3.1 ;ali$ation p#og#amme inclu$es t,e ve#ification of t,e p#oce$u#es use$ to ope#ate t,e system an$ to "eep it in a state of cont#ol. 49amples of t,ese p#oce$u#es inclu$e sta#t7up an$ flus,ing p#io# to $aily use $aily monito#ing of "ey cont#ol pa#amete#s cleaning s an$ sanitiBation of pipe lines an$ sto#age tan"s etc. ,ese p#oce$u#es s,all be consistently folloe$ $u#ing t,e vali$ation stu$y so t,at a$e(uate e9pe#imental $ata a#e obtaine$ to suppo#t t,ei# effectiveness. Pe#sonnel ope#ating t,e system
s,all be t#aine$ in t,ese p#oce$u#es.
Ot,e# "ey
pa#amete#s an$ t,ei# ope#ating #anges s,all be finaliBe$ afte# t,e vali$ation p#og#amme. 5"1"4
M!inten!ne 7&oed'&e *.1..1 -aintenance p#oce$u#es s,all ensu#e consistent $elive#y of t,e $esi#e$ (uantity an$ (uality of ate#. ,ese p#oce$u#es may inclu$e sanitiBation filte# sanitiBation an$ c,ange =; lig,t monito#ing an$ #eplacement etc. )ll t,e p#eventive maintenance p#oce$u#es must be consistently folloe$.
5"1".
Du#ing t,e P,ase7I stu$ies sampling p#og#amme inclu$e sampling of t,e ate# fo# c,emical an$ mic#obial testing at va#ious points on
D- ate#
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system an$ #eci#culation system cove#ing va#ious use# points. ,e effectiveness of t,e system is evaluate$. 5"1"5
Du#ing t,e P,ase CII
testing t,e f#e(uency of sampling numbe# of
samples ta"en an$ numbe# of sampling locations a#e #e$uce$ f#om P,ase7I 5"$
&ief De&i7tion of Te M!
unit . ,is a##angement ,elps in cont#olling t,e
mic#obiological (uality of t,e ate#. 5"$"1
So'&e W!te& * o&e W!te&
5"$"$
Sto&!3e T!n9 fo& feed =!te& Sto#age tan"s a#e siBe$ p#ope#ly $epen$ing on t,e p#ojecte$ pea" $eman$ on t,e ope#ating systems. ,e sto#age tan" fo# sou#ce #a ate# is of 10 & capacity.
5"$"+
S!nd ed
5"$"4
C!&>on ed
5"$".
R O W!te&
Reve#se Osmosis is a tec,nology t,at is use$ to #emove a la#ge majo#ity of contaminants f#om ate# by pus,ing t,e ate# un$e# p#essu#e t,#oug, a semi7pe#meable memb#ane. 5"$"5
C!tion ed :e#e negatively c,a#ge$ ions a#e e9c,ange$.
6ationic #esins a#e
#egene#ate$ it, ,y$#oc,lo#ic aci$. 5"$" ; Anion ed :e#e positively c,a#ge$ ions a#e e9c,ange$. )nionic #esins a#e #egene#ate$ it, so$ium ,y$#o9i$e ,ic, #eplace captu#e$ negative ions it, ,y$#o9i$e ions.
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Mi@ed ed -i9e$ be$ $e7ioniBes a#e use$ to give t,e final ion e9c,ange pu#pose. ,is be$ is use$ fo# imp#oving t,e c,emical (uality of ate# by #emoving cations an$ anions.
5"$"
Sto&!3e t!n9 fo& 7'&ified =!te& ,e sto#age tan" of pu#ifie$ ate# is ma$e of SS 31* an$ is ,aving a bacte#ial ai# vent filte#. ,e tan" ,as a capacity of 2000 lts.
5"$"10 UV Li3t =; lig,t is use$ as a su#face $isinfectant. =; lig,t is p#ovi$e$ in t,e #eci#culation loop system. ,is is useful in "illing t,e !acte#ia
an$ to
#e$uce t,e bacte#ial p#olife#ation. 5"$"11 Rei&'6!tion S:te8 )ll t,e use# points a#e maintaine$ in continuous ci#culation to avoi$ any to minimiBe t,e bio7bu#$en $evelopment. 5"+
Se8!ti Re7&eent!tion Of W!te& S:te8 Sc,ematic #ep#esentation of ate# system is given in Anne@'&e2I
5"4
S!876in3 Lo!tionB Tet P6!n !nd f&e'en: SAMPLIN% METODE 2%0ml of sample is $#an fo# mic#obial an$ %00 ml of ate# fo# c,emical testing s,oul$ be $#an f#om t,e taps afte# sp#aying t,e sampling points it, 0F IP) an$ t,en flus,ing out ate# fo# a fe secon$s. ,e sampling s,oul$ be $one in an aseptic manne#. Samples fo# mic#obial testing a#e collecte$ in ste#ile bottles.
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5". S!876in3 Lo!tionE S!876in3 Point No
S!876in3 Lo!tion
Tet 76!n
Tet f&e'en: fo& +0 d!: ( P!e I#
Tet f&e'en: fo& ne@t 1. d!: (P!e II#
)s an$ ,en #e(ui#e$
)s an$ ,en #e(ui#e$
!/G 01
'ee$ ate#
6,emical )nalysis an$ -ic#obial )nalysis
R/ G01
)fte# San$ !e$
-ic#obial testing
Daily
R/G 02
)fte# 6a#bon !e$
-ic#obial testing
Daily
RO/G 01
R O /ate#
6,emical @ p: > con$uctivityA -ic#obial analysis
Daily
RO/ G02
)fte# 6ation !e$
-ic#obial analysis
Daily
RO/ G03
)fte# )nion !e$
-ic#obial analysis
Daily
P/ G01
)fte# -i9e$ !e$
-ic#obial analysis
Daily
P/ G02
Pu#ifie$ ate# sto#age tan"
6,emical esting -ic#obial analysis
Daily
P/G 03
)fte# =; it, 0.2 H filte#
-ic#obial analysis
Daily
Daily Daily Daily
Daily Daily Daily Daily
Daily
VALIDATION PROTOCOL FOR PURIFIED WATER SYSTEM Document No.
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S!876in3 Point
S!876in3
No
Lo!tion
P/ 0 to P/ 0
P/G 0
P/ G0%
P/ 0*
P/ G0
Date of Issue
Tet 76!n
Page No.
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Tet fo& f&e'en: +0 d!:
Tet f&e'en: 1. d!:fo& ne@t
( P!e I#
(P!e II#
Daily
Daily
Daily
Daily
6,emical testing =S4R POINS
on poole$ sample f#om use# points
-anufactu#ing
6,emical testing
;essel afte# =;
-ic#obial analysis
/as, Room
8uality 6ont#ol
-ic#obiology
5"5 Ae7t!ne C&ite&i!
6,emical testing -ic#obial analysis 6,emical testing -ic#obial analysis 6,emical testing -ic#obial analysis
Daily Daily Daily Daily Daily Daily
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Page No. Tet
11 of 14
Ae7t!ne &ite&i!
1
'ee$ ate#
p: :a#$ness -ic#obial count
Reco#$
2
)fte# San$ !e$
p: :a#$ness -ic#obial count
Reco#$
3
)fte# 6a#bon !e$
p: :a#$ness -ic#obial count
Reco#$
R O /ate#
p:
%.07.0
6on$uctivity
N- µs
-ic#obial count
Not mo#e t,an %00 cfuGml
Pat,ogens
)bsent
-ic#obial count
Not mo#e t,an %00 cfuGml
Pat,ogens
)bsent
-ic#obial count
Not mo#e t,an %00 cfuGml
Pat,ogens
)bsent
p:
%.07.0
6on$uctivity
Not mo#e t,an 1 µs
-ic#obial count
N- %00cfuGml
pat,ogens
)bsent
3.
.
%.
*.
.
)fte# cation be$
)fte# anion be$
)fte# mi9e$ be$
Pu#ifie$ ate# sto#age tan"
)fte# =; G0.2 H filte#
=se# points
6,emical tests as pe# pu#ifie$ )s pe# IP ate# specs p: E %.0 7 .0 IP >I: specs con$uctivity E N- 1 µs -ic#obial count Not mo#e t,an 100 cfuGml Pat,ogens
)bsent
-ic#obial count
N- 100cfuGml
Pat,ogens
)bsent
-ic#obial count in$ivi$ually
N- 100 cfuGml
Pat,ogens
)bsent
6,emical sample
testing
on
Pat,ogens E 4.coli Salmonella S.au#eus P.ae#uginosa
poole$ )s pe# Pu#ifie$ ate# specs I.P p: E %.07.0 6on$uctivity E N- 1 µs
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5"; P&eent!tion of !6id!tion &e'6t ;ali$ation test #esults a#e g#ap,ically p#esente$ along it, t,ei# #espective limits ,e folloing cont#ol c,a#t s,all be inclu$e$ in t,e #epo#t So'&e R!= W!te&* ♦
6ont#ol c,a#t fo# otal :a#$ness values of #a ate#
♦
6ont#ol c,a#t fo# otal Soli$s values of #a ate#
♦
6ont#ol c,a#t fo# otal -ic#obial count of #a ate#
P'&ified =!te& E ♦
6ont#ol c,a#t fo# otal -ic#obial count afte# mi9e$ be$
♦
6ont#ol c,a#t fo# otal -ic#obial count afte# =; &
♦
6ont#ol c,a#t fo# otal -ic#obial count afte# sto#age tan"
Ue& Point* ♦
5"?
6ont#ol c,a#t fo# otal -ic#obial count
E!6'!tion of d!t! !nd 7&e7!&!tion of S'88!&: Re7o&t ,e vali$ation #esults of p,ase I an$ p,ase II stu$ies a#e evaluate$. )fte# t,e evaluation of t,e test #esults a summa#y #epo#t is ma$e on t,e vali$ation fin$ings. P#otocol $eviations if any a#e i$entifie$ along it, t,e #eason fo# t,e $eviation an$ its impact on t,e outcome of t,e vali$ation. It also inclu$es a $iscussion in ,ic, all fin$ings conclusions an$ #ecommen$ations a#e note$. P#otocol $eviation s,oul$ be justifie$ an$ aut,o#iBe$ by 8uality )ssu#ance In summa#y #epo#t all t,e 8uality pa#amete#s at $iffe#ent locations a#e compa#e$ it, specifie$ cont#ol &imits. Summa#y #epo#t is p#epa#e$ by 8uality cont#ol $epa#tment an$ app#ove$ by 8uality assu#ance $epa#tment.
5"
Con6'ion !nd Reo88end!tion
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)fte# t,e completion of monito#ing t,e #esults cove#ing all t,e t,#ee seasons an )nnual Summa#y is ma$e. :e#e t,e ave#age value of eac, 8uality pa#amete# at all sampling locations fo# eac, season is compa#e$ it, #espective limits. )nnual summa#y #epo#t is also co##elate$ it, t,e majo# b#ea" $on @if anyA an$ no#mal p#eventive maintenance p#og#am of t,e /ate# System.
'inally a
statement #ega#$ing t,e out come of t,e vali$ation of t,e /ate# #eatment System is ma$e. 5"10
C!n3e Cont&o6 In case of any subse(uent c,anges to vali$ate$ ate# t#eatment system li"e c,ange of a pa#ticula# component etc can be ma$e only t,#oug, a p#ope# c,ange cont#ol p#oce$u#e. ,e p#oce$u#e specifies a met,o$ fo# $ocumenting p#opose$ c,anges an$ assigns #esponsibility to specific in$ivi$uals fo# assessing t,e impact of c,ange on vali$ate$ system. )n app#op#iate #evali$ation plan an$ a #evali$ation p#otocol ill be #e(ui#e$ in suc, case. )ll c,ange cont#ol #evali$ations plan s,all be #eviee$ an$ app#ove$ by 8uality )ssu#ance
DEPARTMENT 4nginee#ing P#o$uction
8uality cont#ol
8uality )ssu#ance
NAME
SI%NATURE
DATE
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