CLEANING VALIDTION PROTOCOL

Document Code: SU 007 Version Number: 007

TITLE:CLEANING VALIDATION O LI!UID ILLING LINE Re"ie#: N$A

CLEANING VALIDATION PROTOCOL TE%PLATE

&RITTEN: Si'n(ture: Position: D(te:

REVIE&ED:

APPROVED Si'n(ture: Position: D(te:

S(m)*e )rotoco* +or 'uid(nce on*,

CLEANING VALIDTION PROTOCOL

Document Code: SU 007 Version Number: 007

TITLE:CLEANING VALIDATION O LI!UID ILLING LINE Re"ie#: N$A

TA.LE O CONTENTS -/ O.0ECTIVE11111111111111111111//2 3/ SCOPE1111111111111111111111///2 2/ RESPONSI.ILIT4 AND AUT5ORIT4111111111///2 6/ RE ERENCED DOCU%ENTS11111111111112 7/ REVIE& O CLEANING DOCU%ENTS11111111//6 7/- E8ui)ment to be c*e(ned11111111111111/6 7/3 Common VS Dedic(ted e8ui)ment11111111116 7/2 C*e(nin' )rocedure (nd c*e(nin' e8ui)ment111111//6 7/6 5o*din' times111111111111111111//7 9/ SELECTION O &ORST CASE :%AR;ER< OR :&ORST CASE PRODUCT< 9/- E"(*u(tion o+ t=e )roduct mi> to se*ect t=e #orst?c(se )roduct or m(r@er )roduct11111111111111111111111///7 9/3 O)er(tor tr(inin'11111111111111111//7 9/2 C*e(nin' *imits se*ection criteri( b(sed on %AC ())ro(c=1/9 7/ VALIDATION PLAN11111111111111111 7/- &orst?c(se conditions111111111111111/9 7/3 C=emic(* (nd microbio*o'ic(* (n(*,tic(* met=ods1111/9 7/2 Acce)t(nce criteri(1111111111111111/7 A/ SA%PLING LOCATIONS: A/- S#(b (nd +*us= s(m)*in' *oc(tions11111111117

S(m)*e )rotoco* +or 'uid(nce on*,

CLEANING VALIDTION PROTOCOL

Document Code: SU 007 Version Number: 007

TITLE:CLEANING VALIDATION O LI!UID ILLING LINE Re"ie#: N$A

-/ O.0ECTIVE: T=e obBecti"e o+ t=is )rotoco* is to de+ine ())ro(c= to "(*id(tion o+ c*e(nin' )rocedures +or +i**in' (nd +ormu*(tion/ 3/ SCOPE: T=is document co"ers t=e )rotoco* o+ c*e(nin' )rocedures +or +ormu*(tion (nd +i**in' C*e(nin' Procedures: 2/ RESPONSI.ILIT4 AND AUT5ORIT4: T=e +o**o#in' s)eci+ic res)onsibi*ities (nd (ut=orities (re (ssi'ned to t=is )rotoco*: Acti"it, Protoco* Pre)(r(tion Protoco* A))ro"(* +or E>ecution Protoco* E>ecution Re"ie# Test Resu*ts (nd Pre)(re in(* Re)ort in(* Re)ort A))ro"(* Res)onsibi*it, Pre)(r(tion o+ )rotoco* ('(inst c*e(nin' To ensure )rotoco* =(s met its de+ined )ur)ose/ E>ecution o+ test det(i*ed in t=e ())ro"ed )rotoco*C com)i*(tion o+ test resu*ts/ Re"ie# t=e )rotoco* to ensure t=e correctness in e>ecution (nd document in (ccord(nce to s)eci+ic(tions/ To ensure resu*ts demonstr(te obBecti"eness o+ )rotoco*/ Position !A De)(rtment !A (nd En'ineerin' De)(rtment !A De)(rtment !A De)(rtment

!A (nd En'ineerin' De)(rtment

6/ RE ERENCED DOCU%ENTS: E8ui)ment m(nu(* SOP o+ c*e(nin' )rocedure C=emic(* (nd microbio*o'ic(* *imits in P=(rm(co)oei(s

S(m)*e )rotoco* +or 'uid(nce on*,

CLEANING VALIDTION PROTOCOL

Document Code: SU 007 Version Number: 007

TITLE:CLEANING VALIDATION O LI!UID ILLING LINE Re"ie#: N$A

7/ REVIE& O CLEANING DOCU%ENTS: 7/- E8ui)ment to be c*e(ned: T=is )rotoco* #i** (ddress t=e c*e(nin' o+ t=e +o**o#in' )roduct cont(ct e8ui)ment used to m(nu+(cture *i8uid )roducts/ E8ui)ment %i>in' "esse* Vi(* +i**in' (nd c*osin' m(c=ine L(be**in' m(c=ine C(rton(tor reeGe dr,er Rot(r, T(b*e Con"e,or 5(rd to c*e(n (re(s: .ene(t= t=e mi>in' b*(des De(d s)ots in t=e t(n@ De(d *e's 7/3 Common "s Dedic(ted E8ui)ment: Common E8ui)ment: E8ui)ment used +or (** t,)es o+ )rocess/ Dedic(ted E8ui)ment: E8ui)ment used +or on*, s)eci+ic )rocess/ Li8uid +i**in' *ine is used (s dedic(ted e8ui)ment +or +i**in' )rocess/ 7/2 C*e(nin' Procedure (nd C*e(nin' E8ui)ment: 7/2/- %(nu(* C*e(nin' Process: T=e c*e(nin' )rocedure SOP 379 Ver H 02 )ro"ides det(i*s o+ t=e )rocedureC e8ui)ment (nd m(teri( is re8uired in order to conduct m(nu(* ECOPF c*e(nin' o+ t=e *i8uids m(nu+(cture )rocess e8ui)ment/ Critic(*it, r(tin' Critic(* Critic(* Non?critic(* Non?critic(* Non?critic(* Non?critic(* Non?critic(* R(tion(*e Direct cont(ct #it= t=e )roduct Direct cont(ct #it= t=e )roduct DoesnDt (++ect 8u(*it, (nd )urit, Eno direct cont(ctF DoesnDt (++ect 8u(*it, (nd )urit, Eno direct cont(ctF DoesnDt (++ect 8u(*it, (nd )urit, Eno direct cont(ctF DoesnDt (++ect 8u(*it, (nd )urit, Eno direct cont(ctF DoesnDt (++ect 8u(*it, (nd )urit, Eno direct cont(ctF

S(m)*e )rotoco* +or 'uid(nce on*,

CLEANING VALIDTION PROTOCOL

Document Code: SU 007 Version Number: 007

TITLE:CLEANING VALIDATION O LI!UID ILLING LINE Re"ie#: N$A

7/2/3 Autom(ted CIP EProduct to ProductF C*e(nin' S,stem: T=e c*e(nin' )rocedure SOP 079 Ver H 03 )ro"ides det(i*s o+ t=e )rocedureC e8ui)ment (nd m(teri(*s re8uired in order to conduct (utom(ted ECIPF c*e(nin' o+ t=e *i8uids m(nu+(cture )rocess e8ui)ment/ 7/6 5o*din' Times: Dirt, E8ui)ment? %(>imum =o*d Time: &(s=in' time: 20 mins Rinsin' time: -0 mins Dr,in' time: -0 mins C*e(ned E8ui)ment? %(>imum 5o*d Time: &(s=in' time: 30 mins Rinsin' time: 7 mins Dr,in' time: 7 mins 9/ SELECTION O &ORST CASE I%AR;ERD OR I&ORST?CASED PRODUCT: T=e I&orst?C(seD )roduct r(n'e =(s been determined b, se"er(* +(ctors inc*udin' stren't=C to>icit,C e>ci)ients (nd so*ubi*it,/ 9/- E"(*u(tion o+ t=e )roduct mi> to se*ect t=e #orst?c(se )roduct or m(r@er )roduct/ Doses (nd .(tc= SiGe In+orm(tion Product P(r(cet(mo* Sus)ension C=est, Cou'= S,ru) Decon'est(nt n(s(* S)r(, Linctus P(edi(tric Emu*sion Stren't= -30 m' 300 m' 0/7 m' 7/7 m' 0/07 m' 370 m' So*ubi*it, S)(rin'*, so*ub*e S)(rin'*, so*ub*e So*ub*e ree*, so*ub*e Pr(ctic(**, inso*ub*e Pr(ctic(**, inso*ub*e .(tc= siGe DecisionJJ -066 ;' 3-70 ;' 33K/7 ;' --60 ;' 333 ;' A-9 ;' %(r@er %(r@er %(r@er

S(m)*e )rotoco* +or 'uid(nce on*,

CLEANING VALIDTION PROTOCOL

Document Code: SU 007 Version Number: 007

TITLE:CLEANING VALIDATION O LI!UID ILLING LINE Re"ie#: N$A

T=ree )roducts (re se*ected (s m(r@er (s t=eir so*ubi*ities (re "er, *o# (nd to>icit, r(n'es +rom =i'= to mediumC e"en more b(tc= siGe (nd )ossibi*it, o+ residue #i** be more/ 9/3 O)er(tor Tr(inin': O)er(tor )er+ormin' t=e c*e(nin' )ro'r(mme s=ou*d be )ro)er*, tr(ined (nd (ssessed be+ore t=e, st(rt c*e(nin' )rocess/ T=e tr(inin' records (nd (ssessment s=ou*d be )reser"ed/ 9/2 C*e(nin' Limits Se*ection Criteri( b(sed on %AC A))ro(c=: %(>imum A**o#(b*e C(rr,o"er E%AC FLTDM .(tc= NPM-000MS NLD Dose NP TDL Sm(**est t=er()eutic dose o+ (cti"e Bust c*e(ned Em'F .(tc= NPL .(tc= siGe o+ ne>t )roduct E;'F S L S(+et, +(ctor E0/00- is commonF LD Dose NPL %(>imum number o+ d(i*, doses o+ t=e ne>t )roduct Em'F %(r@er )roduct is P(edi(tric E*i>er/ Its %AC is 0/0-/ %ACL0/7M0/00-M3-70M-000M0/00-N9M-7M-/--2 L -/077N-00/-7 L 0/07/ VALIDATION PLAN: 7/- &orst?c(se conditions: T=e CIP SOP H 379 Ver 03 cont(ins se"er(* #orst?c(se conditions/ T=e )rocedure is (s +o**o#s/ -/ T=e t(n@ s=ou*d be #(s=ed (s soon (s )ossib*e )ost use but must be #(s=ed #it=in 6 =ours o+ use/ 3/ Com)*ete*, dr(in (n, residu(* bu*@ )roduct +rom t=e t(n@ "i( t=e dr(in *ine/ 2/ Att(c= t=e s)r(, b(** (nd ())*, ( -0?-7 minute )rocess #(ter rinse to (** sur+(ces o+ t=e t(n@C inc*udin' under t=e *id/ %(@e sure t=e #(ter is (bo"e 70C be+ore commencin' t=e +*us=/ 6/ i** t=e t(n@ to t=e =i'= *e"e* m(r@ #it= ( +res=*, )re)(red -O "$" o+ Decon deter'ent in )uri+ied #(ter/ C=ec@ t=(t t=e )5 is bet#een 7/A (nd A/2/

S(m)*e )rotoco* +or 'uid(nce on*,

CLEANING VALIDTION PROTOCOL

Document Code: SU 007 Version Number: 007

TITLE:CLEANING VALIDATION O LI!UID ILLING LINE Re"ie#: N$A

7/ A))*, ( +u** so(@ #it= s*o# t(n@ ('it(tion +or 77?97 minutes/ 9/ Dr(in t=e t(n@ (nd +*us= t=e deter'ent residue to dr(in #it= ( minimum o+ -00 *itres o+ )uri+ied #(ter/ 7/ A))*, ( +in(* -00 *itre +*us= #it= =ot )uri+ied #(ter t=rou'= t=e s)r(, b(**/ T=is #i** t(@e ())ro>im(te*, 7 minutes to com)*ete/ On com)*etion o+ t=e +in(* rinse b*o# +i*tered com)ressed (ir into t(n@ to remo"e (** #(ter residues/ A/ Visu(**, ins)ect t=e t(n@ +or c*e(n*iness (+ter turnin' on t=e )i*ot *i'=t to i**umin(te t=e t(n@ inner sur+(ces/ .e sure to c=ec@ (t *e(st +o**o#in' t=ree *oc(tions underne(t= t=e *idC (n, "ertic(* sur+(ceC underne(t= t=e stirrer b*(de/ K/ Record t=e resu*ts o+ t=e ins)ection on t=e t(n@ c*e(nin' *o'/ T=e #orst?c(se conditions (re: Products =("in' =i'= to>icit, (nd *o# so*ubi*it, s=ou*d be considered (s m(r@er (s i+ t=e, c(n be c*e(ned #it=out (n, to>ic residue t=en (** ot=ers c(n be c*e(ned/ 5i'= to>icit, (nd *o# so*ubi*it,L P(edi(tric E*i>er %edium to>icit, (nd medium so*ubi*it,L C=est, cou'= s,ru) 5i'= to>icit, (nd =i'= so*ubi*it,L Dr, cou'= *inctus 7/3 C=emic(* (nd %icrobio*o'ic(* An(*,tic(* %et=ods: !u(*it, Contro* L(bor(tor,: or detectin' t=e c=emic(* residues 5PLC is used / ANAL4TE Protein Or'(nic Com)ounds Inor'(nic Com)ounds %ET5OD 5PLC 5PLC Conducti"it, o+ rinse #(ter

S(m)*e )rotoco* +or 'uid(nce on*,

CLEANING VALIDTION PROTOCOL

Document Code: SU 007 Version Number: 007

TITLE:CLEANING VALIDATION O LI!UID ILLING LINE Re"ie#: N$A

!u(*it, Contro* %icrobio*o', L(bor(tor,: Ce** cu*ture (nd st(inin' met=ods (re used +or detectin' microbes/ VIRUSES %et=ods +or detectin' Ce** cu*ture (nd count )*(8ue +ormin' units .ACTERIA Se*ecti"e 'ro#t= (nd count co*on, +ormin' units PARASITIC PROTOPOA Immuno*o'ic(* st(inin' (nd count +*uorescent c,sts

7/2 Acce)t(nce Criteri(: or C=emic(*s: -/ Not more t=(n 0/-O o+ t=e norm(* d(i*, dose #i** ())e(r in t=e m(>imum d(i*, dose o+ t=e )roduct/ 3/ Not more t=(n -0 ))m o+ (n, )roduct to ())e(r in (not=er )roduct/ 2/ No residue o+ =,)oc=*orite s=ou*d be identi+ied/

A/ SA%PLING LOCATIONS: A/- S#(b (nd +*us= s(m)*in' *oc(tions E+or t(n@F: S#(b Number SS3 S2 S6 S7 *us= Number S#(b Loc(tion E-00 s8u(re cmF Under mi>in' t(n@ *id Ri'=t side #(** sur+(ce Under t=e mi>in' b*(de V(*"es Pi)es -000m* o+ +in(* +*us= )uri+ied #(ter Dr(in *ine +rom bu*@ t(n@

S(m)*e )rotoco* +or 'uid(nce on*,

CLEANING VALIDTION PROTOCOL

Document Code: SU 007 Version Number: 007

TITLE:CLEANING VALIDATION O LI!UID ILLING LINE Re"ie#: N$A

S#(b (nd +*us= s(m)*in' *oc(tions E+or +i**in' *ineF: S#(b Number S*us= Number S#(b Loc(tion E-00 s8u(re cmF i**in' =e(d -000m* o+ +in(* +*us= )uri+ied #(ter Dr(in *ine +rom +i**er

S(m)*e )rotoco* +or 'uid(nce on*,