vmp-01
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Validation Master PlanTRANSCRIPT
Document No.ALB/F/VMP/001-01ALEMBIC LIMITED BADDISupersede:ALB/F/VMP/001-00VALIDATION MASTER PLAN Pageo! "#E!!ect$%e Date15.11.2005&'ALIT( ASS'RANCE DEPARTMENT Re%$e) Date14.11.2007VALIDATION MASTER PLANA*em+$c L$m$tedP*ot No. ", ""- EPIP P.ase/I- 0.arma1r$- Badd$- D$stt./ So*an- 2.P.Document No.ALB/F/VMP/001-01ALEMBIC LIMITED BADDISupersede:ALB/F/VMP/001-00VALIDATION MASTER PLAN Page " o! "#E!!ect$%e Date15.11.2005&'ALIT( ASS'RANCE DEPARTMENT Re%$e) Date14.11.2007VALIDATION MASTER PLANAPPROVALAct$%$t3NameArea Representat$%e S$gnature 4 Date Prepared bA.!. T"#bar$a Sr. E%e&"'$(e-) ARe($e*ed b !a$+a,- .ada( E/0$/eer$/0 1eadV$2a !ar*a Pr3&e,, De(e+3p#e/' Lab.30e,- Ara Ma/a0er )"a+$' 43/'r3+Appr3(ed b V Ba+a2$ )"a+$' 1eadDe(e/dra V$2a P+a/' 1eadDr. Ba+*a/' De,a$ VP - )"a+$' 5 RADocument No.ALB/F/VMP/001-01ALEMBIC LIMITED BADDISupersede:ALB/F/VMP/001-00VALIDATION MASTER PLAN Page 5 o! "#E!!ect$%e Date15.11.2005&'ALIT( ASS'RANCE DEPARTMENT Re%$e) Date14.11.2007Ta+*e o! ContentsPart$cu*arsPage No.1.0 I/'r3d"&'$3/04 2.0 Va+$da'$3/ Ma,'er P+a/2.1Va+$da'$3/ P3+$&05 2.2S&3pe 36 Va+$da'$3/05 2.7Va+$da'$3/ Tea#08 2.4 D3&"#e/'a'$3/072.5Va+$da'$3/ Pr3&e,, 09 2.8Re(a+$da'$3/ 11 7.0Va+$da'$3/ Appr3a&-7.1:,er Re;"$re#e/' Spe&$6$&a'$3/,12 7.2F"/&'$3/a+ Spe&$6$&a'$3/17 7.7De,$0/ Spe&$6$&a'$3/17 7.4S'a0e 36 )"a+$6$&a'$3/17 7.5 Ba,$, 36 A&&ep'a/&e 14 4.0A/a+'$&a+ Me'-3d Va+$da'$3/ 15 5.0 4+ea/$/0 Va+$da'$3/ 17 8.0Pr3&e,, Va+$da'$3/ 1< 7.0Fa&$+$' )"a+$6$&a'$3/19 T-$,d3&"#e/' ,er(e,a,'-e Va+$da'$3/r3ad#ap? ,e''$/0'-e&3"r,e? 2",'$6$/0'-e,'ra'e0?3"'+$/$/0 '-e pre+$#$/ar 'e,' a/d a&&ep'a/&e &r$'er$a? a/d d3&"#e/'$/0 '-e /e&e,,ar pr30ra#,'-a' e/,"re a &3/'$/"$/0 ,'a'e 36 (a+$da'$3/. O%er%$e) o! t.e P*ant:A+e#b$& +$#$'ed @F3r#"+a'$3/ D$($,$3/A? Badd$ $, a #"+'$-pr3d"&'? #"+'$-p"rp3,e a ,3+$d 3ra+d3,a0e 63r#-Tab+e' 5 4ap,"+e a/d +$;"$d 3ra+ d3,a0e 63r#-Sr"p a/d S",pe/,$3/,#a/"6a&'"r$/0 6a&$+$' +3&a'ed ab3"' 40 !#,. a*a 6r3# 4-a/d$0ar-. T-e ba,$& 6ea'"re, 36 '-e 6a&$+$' are a, 63++3*,> T-ereare,epara'eBra/"+a'$3/6a&$+$'$e,a$#eda' #"+'$p+eba'&-,$Cere;"$re#e/' a+3/0*$'- ,epara'e &3#pre,,$3/ a/d &3a'$/0 6a&$+$'. I/'e0ra'ed 1ard Be+a'$/ 4ap,"+e F$++$/0 L$/e. Separa'e Pr$#ar pa&D$/0 +$/e? 63r (ar$3", 'pe, 36 pr$#ar pa&Da0$/0 $/&+"d$/0 63$+? b+$,'erpa&D$/0. A++ ,er($&e,? $/&+"d$/0 A$r -a/d+$/0 ,,'e# are &rea'ed '3 a&&e,, 6r3# area ,epara'ed 6r3#'-e 3pera'$/0 area. T-e #a'er$a+ a/d per,3//e+ 6+3*? pre,,"re C3/$/0? a$r 6$+'ra'$3/ a/d d",' e%'ra&'$3/ ,,'e#are de,$0/ed #a'&-$/0 *$'- '-e re;"$re#e/' 36 #"+'$pr3d"&' -a/d+$/0. T-e p+a/' -a, $/depe/de/' )"a+$' &3/'r3+ +ab3ra'3r 63r r3"'$/e )"a+$' 'e,'$/0. N3 &'3'3%$&? be'a +a&'"#,? &ep-a+3,p3r$/? -3r#3/e, ,-a++ be #a/"6a&'"red $/ '-$, 6a&$+$'. Document No.ALB/F/VMP/001-01ALEMBIC LIMITED BADDISupersede:ALB/F/VMP/001-00VALIDATION MASTER PLAN Page # o! "#E!!ect$%e Date15.11.2005&'ALIT( ASS'RANCE DEPARTMENT Re%$e) Date14.11.2007".7 VALIDATION MASTER PLAN ". Va*$dat$on Po*$c3: Va+$da'$3/ ,-a++ be ",ed a, a '33+ 63r pr3($d$/0 a -$0- de0ree 36 a,,"ra/&e '-a' a ,pe&$6$&,,'e#? pr3&e,,? 3r6a&$+$'*$++ &3/,$,'e/'+pr3d"&eapr3d"&' #ee'$/0$',prede'er#$/ed,pe&$6$&a'$3/, a/d ;"a+$' a''r$b"'e,. T-e3r0a/$Ca'$3/,-a++ pr3($de'-e/e&e,,arre,3"r&e, 63r 3r0a/$C$/0a/de%e&"'$/0'-e(a+$da'$3/ a&'$($'. I/ ,$'"a'$3/ 36 #"+'$p+e (a+$da'$3/ 'a,D,? pr$3r$' ,-a++ be de&$ded ba,ed 3/ '-e ,e(er$' a/dr$,D 6a&'3r $/(3+(ed *$'- '-3,e 'a,D,-'-e Va+$da'$3/ P+a/ ,-a++ be #ade a&&3rd$/0+.4-a/0e&3/'r3+ a/dre(a+$da'$3/&r$'er$a,-a++ bee,'ab+$,-eda/d$#p+e#e/'ed'3$de/'$6?d3&"#e/' a/dre($e*&-a/0e,'3a++ (ar$ab+e,'-a' &3"+da+'er'-e(a+$da'ed,'a'e36ea&-#a/"6a&'"r$/0 pr3&e,,. Pr$#arre,p3/,$b$+$'63r e%e&"'$3/36 (a+$da'$3/a&'$(e, ,-a++ beS$'e;"a+$'-ead. T-eS'eer$/0 43##$''ee 63r Va+$da'$3/ ,-a++ per$3d$&a++ re($e* E%$,'$/0 (,. A(a$+ab+e Te&-/3+30a/d +$#$'a'$3/, 36 '-e E%$,'$/0 Te&-/3+30. T-e Va+$da'$3/ Ma,'er P+a/ ,-a++ be "pda'ed '3$/&3rp3ra'e /e* &-a/0e,."." Scope o! Va*$dat$on:T-$, VMP ,-a++beapp+$&ab+e'3 a++'-e Va+$da'$3/a&'$($'$e,&3(er$/0Ma/"6a&'"r$/0? )"a+$'43/'r3+? )"a+$'A,,"ra/&ea/dE/0$/eer$/06"/&'$3/,'3be"/der 'aDe/a'A+e#b$&+$#$'ed@F3r#"+a'$3/ D$($,$3/A? Badd$.Document No.ALB/F/VMP/001-01ALEMBIC LIMITED BADDISupersede:ALB/F/VMP/001-00VALIDATION MASTER PLAN Page 8 o! "#E!!ect$%e Date15.11.2005&'ALIT( ASS'RANCE DEPARTMENT Re%$e) Date14.11.2007F3++3*$/0 area, ,-a++ be &3(ered "/der )"a+$6$&a'$3/ / (a+$da'$3/>-&ua*$!$cat$on: Fa&$+$' )"a+$6$&a'$3/? 4r$'$&a+ Pr3&e,, e;"$p#e/' a/d +ab $/,'r"#e/' ;"a+$6$&a'$3/ a/d :'$+$';"a+$6$&a'$3/ @=a'er ,,'e#? 1VA4? 43#pre,,ed a$r e'&.AVa*$dat$on: A/a+'$&a+ Me'-3d, Ma/"6a&'"r$/0 Pr3&e,,e, 4+ea/$/0 Me'-3d, a/d Pr3&ed"re, 43#p"'er S,'e#, @MMI /PL4/P4 e'&.A E*-ere(er app+$&ab+e. Ma'er$a+ $/(e/'3r ,,'e# @SAPA a/d BMS ,,'e#. ".5 Va*$dat$on TeamVa*$dat$on Steer$ng Comm$ttee>I' ,-a++ &3#pr$,e 36>1. 1ead -)"a+$' 2. 1ead-Ma/"6a&'"r$/0 T-e ,'eer$/0 &3##$''ee ,-a++ /3#$/a'e '-e Va+$da'$3/ 'ea# a, per '-e re,pe&'$(e (a+$da'$3/ 'a,D> Va*$dat$on Team>Va+$da'$3/ Tea# ,-a++ be a ded$&a'ed 0r3"p 36 per,3/? *-3,e pr$/&$pa+ 'a,D *$++ be 36 Va+$da'$3/. 43rp3ra'e )"a+$' 1ead ,-a++ be '-e 4-a$rper,3/ 36 (a+$da'$3/ 'ea#. T-e 'ea# ,-a++ be &3#pr$,ed36 3/e /3#$/ee 6r3# ea&- 36 '-e 63++3*$/0 area, a, per app+$&a'$3/>1. Pr3d"&'$3/ Depar'#e/'2. )"a+$' 43/'r3+ Lab3ra'3r 7. E/0$/eer$/0 Ser($&e, 4. )"a+$' A,,"ra/&e5. Pr3&e,, De(e+3p#e/' Lab.Document No.ALB/F/VMP/001-01ALEMBIC LIMITED BADDISupersede:ALB/F/VMP/001-00VALIDATION MASTER PLAN Page 9 o! "#E!!ect$%e Date15.11.2005&'ALIT( ASS'RANCE DEPARTMENT Re%$e) Date14.11.2007Me#ber, 36 '-$, 'ea# ,-a++ be /3#$/a'ed $/ &3/,"+'a'$3/ *$'- '-e re,pe&'$(e depar'#e/' -ead,a/d ,-a++ be appr3(ed b '-e ,'eer$/0 &3##$''ee. T-e 'ea# ,-a++ be re,p3/,$b+e 63r $de/'$6$/0?p+a//$/0? 3r0a/$C$/0? a/d &3-&33rd$/a'$/0? #3/$'3r$/0 a/d d3&"#e/'$/0 (a+$da'$3/ e%er&$,e.".6 Documentat$on: O/&e '-e Va+$da'$3/ P+a/ $, #ade? ,pe&$6$& Va+$da'$3/ 'a,D, ,-a++ be"/der'aDe/ a/d d3&"#e/', ,-a++ be de,$0/ed.".6. T3pes o! Document:T-e Va+$da'$3/ d3&"#e/'a'$3/ ,-a++ &3/,$,' 36> Va+$da'$3/ Pr3'3&3+ Va+$da'$3/ Rep3r'Va+$da'$3/ Pr3'3&3+ ,-a++ be a *r$''e/ p+a/ ,'a'$/0 -3* (a+$da'$3/ *$++ be &3/d"&'ed? $/&+"d$/0 'e,'para#e'er,? pr3d"&' &-ara&'er$,'$&,? pr3d"&'$3/e;"$p#e/' a/da&&ep'a/&e&r$'er$a. I' ,-a++ a+,3de,&r$be '-e &r$'er$a 63r re-(a+$da'$3/ /re-;"a+$6$&a'$3/.A (a+$da'$3/ pr3'3&3+ ,-a++ &3/'a$/ 63++3*$/0 $/63r#a'$3/ S&3pe De,&r$p'$3/ 36 $'e# 3r ,,'e# '3 be (a+$da'ed 3r ;"a+$6$ed. Te,', '3 be &arr$ed 3"' Re,p3/,$b$+$'$e, e'&. Va+$da'$3/ Rep3r' ,-a++ ,&$e/'$6$&a++ e(a+"a'e '-e da'a &3++e&'ed d"r$/0 '-e (a+$da'$3/ e%er&$,e a/d&3/&+"de($,-F-($,'-e(a+$da'$3/pr3'3&3+. I',-a++a+,3re&3rd'-e&3/&+",$3/36'-e(a+$da'$3/e%er&$,e a/d $6 re;"$red ,-a++ 0$(e '-e re&3##e/da'$3/ 63r &er'a$/ #3d$6$&a'$3/, be63re are(a+$da'$3/ $, d3/e.Document No.ALB/F/VMP/001-01ALEMBIC LIMITED BADDISupersede:ALB/F/VMP/001-00VALIDATION MASTER PLAN Page : o! "#E!!ect$%e Date15.11.2005&'ALIT( ASS'RANCE DEPARTMENT Re%$e) Date14.11.2007".6." C.ange Contro*:4-a/0e 43/'r3+ ,,'e# ,-a++ pr3($de a pr3&ed"re b *-$&- a/ pr3p3,ed 3r a&'"a+ &-a/0e $/'3,,'e# @e$'-er $/ ,36'*are 3r -ard*are re+a'ed a,pe&',A - '-a' #$0-' a66e&' a (a+$da'ed ,'a'",? ,-a++be re($e*ed. T-e $/'e/' $, '3 de'er#$/e '-e /eed 63r a&'$3/ '-a' *3"+d e/,"re a/d d3&"#e/' '-a''-e ,,'e# $, #a$/'a$/ed $/ a (a+$da'ed ,'a'e. ".6.5 Preparat$on- Re%$e) and Appro%a* o! Va*$dat$on Documents:A++ (a+$da'$3/ d3&"#e/', ,-a++ be prepared? re($e*ed a/d appr3(ed b a"'-3r$Ced per,3//e+ 36 '-eVa+$da'$3/ Tea# '3 e/,"re '-e$r &3rre&'/e,, a/d $#pa&' 3/ '-e ,,'e# a, 63++3*,>)"a+$' a,,"ra/&e per,3//e+? $/ &3/,"+'a'$3/ *$'- re,pe&'$(e +$/e ,"per($,3r/#a/a0er *-3 $,re,p3/,$b+e 63r '-e $#p+e#e/'a'$3/ 36 '-e ,,'e#? ,-a++ &-e&D '-e Va+$da'$3/ Pr3'3&3+ a/dVa+$da'$3/ Rep3r'a+3/0*$'-'-eS"pp3r'$/0D3&"#e/', +$De Spe&$6$&a'$3/-Me'-3d36 A/a+,$,?4er'$6$&a'e 36 A/a+,$,. 43rp3ra'e )"a+$' E/0$/eer$/0 per,3//e+, pr3($de ba,$& 'e#p+a'e a/d 0"$de+$/e, 63r '-eprepara'$3/ 36 '-e d3&"#e/',.T-e Me#ber, 36 Va+$da'$3/ Tea# ,-a++ prepare 5 re($e* '-e Va+$da'$3/ pr3'3&3+ a/d Va+$da'$3/Rep3r'.T-eS'eer$/043##$''ee#e#ber,,-a++ appr3(e'-e Va+$da'$3/Pr3'3&3+a/d Va+$da'$3/Rep3r'.".6.6 Arc.$%a* , Cop$es:T-e Va+$da'$3/ d3&"#e/', ,-a++ be ar&-$(ed b )"a+$' A,,"ra/&e Depar'#e/' a, per '-e S'a/dardOpera'$/0 pr3&ed"re.Document No.ALB/F/VMP/001-01ALEMBIC LIMITED BADDISupersede:ALB/F/VMP/001-00VALIDATION MASTER PLAN Page ; o! "#E!!ect$%e Date15.11.2005&'ALIT( ASS'RANCE DEPARTMENT Re%$e) Date14.11.2007".# Va*$dat$on Process:Pr$3r '3 (a+$da'$3/ 36 a/ ,,'e# a++ /e&e,,ar )"a+$6$&a'$3/ 36 '-e &3#p3/e/', 36 '-e ,,'e# ,-a++be &3#p+e'ed a/d rep3r' ,-a++ be re($e*ed a/d appr3(ed b '-e Va+$da'$3/ &3##$''ee.T-e )"a+$6$&a'$3/ 36 a/ 43#p3/e/' 36 a ,,'e# / e;"$p#e/' e%er&$,e $/&+"de,> :,er Re;"$re#e/' ,pe&$6$&a'$3/ @ :RSA De,$0/ )"a+$6$&a'$3/ @ D)A I/,'a++a'$3/ )"a+$6$&a'$3/ @I)A Opera'$3/ )"a+$6$&a'$3/.@O)A Per63r#a/&e )"a+$6$&a'$3/ @ P)AA++ #ea,"r$/0 I/,'r"#e/', '3 be ",ed d"r$/0 '-e )"a+$6$&a'$3/ a/d Va+$da'$3/ e%er&$,e ,-3"+d be&a+$bra'ed '3 a 'ra&eab+e /a'$3/a+ 3r $/'er/a'$3/a+ ,'a/dard. T-e Va+$da'$3/ e%er&$,e ,-a++ be d3/e b ad3p'$/0 a/ 36 '-e 63++3*$/0 appr3a&- *-$&- e(er $,,"$'ab+e- Pr3,pe&'$(e ba,$,? 43/&"rre/' ba,$,? 3r Re'r3,pe&'$(e ba,$,.Prospect$%e Va*$dat$on: I' ,-a++ be per63r#ed be63re a/ e/'$re+ /e* pr3d"&' $, $/'r3d"&ed b '-e &3#pa/? 3r *-e/ '-ere $,a&-a/0e$/'-e#a/"6a&'"r$/0pr3&e,,? *-$&-#aa66e&' '-epr3d"&'G,&-ara&'er$,'$&,? ,"&-a,"/$63r#$' a/d $de/'$'? e'&.Documentat$on> Pr$3r '3 '-e (a+$da'$3/ e%er&$,e '-ere ,-a++ be pr3per d3&"#e/'a'$3/ 36 '-e Pr3&e,,Op'$#$Ca'$3/ Ba'&-e, a/d ,"b,e;"e/' 'e&-/3+30 'ra/,6er. T-e da'a 63r '-e pr3,pe&'$(e (a+$da'$3/,-a++ a' +ea,' &3#pr$,e36 7,e',36 da'a'-a' are&3/,e&"'$(ea/dareare,"+' 36 ,"&&e,,6"++&3#p+e'ed e%er&$,e,. I' $, e,,e/'$a+ '-a' '-e (a+$da'$3/ pr30ra#$, d3&"#e/'ed a/d '-a' '-ed3&"#e/'a'$3/$,pr3per+#a$/'a$/ed. Appr3(a+ a/dre+ea,e36 '-epr3&e,,63r ",e$/r3"'$/eDocument No.ALB/F/VMP/001-01ALEMBIC LIMITED BADDISupersede:ALB/F/VMP/001-00VALIDATION MASTER PLAN Page 7 o! "#E!!ect$%e Date15.11.2005&'ALIT( ASS'RANCE DEPARTMENT Re%$e) Date14.11.2007#a/"6a&'"r$/0 ,-3"+d be ba,ed "p3/ a re($e* 36 a++ '-e (a+$da'$3/ d3&"#e/'a'$3/? $/&+"d$/0 da'a6r3# '-e e;"$p#e/' ;"a+$6$&a'$3/? pr3&e,, per63r#a/&e ;"a+$6$&a'$3/? a/d pr3d"&'/pa&Da0e 'e,'$/0'3 e/,"re &3#pa'$b$+$' *$'- '-e pr3&e,,.Concurrent Va*$dat$on: I' ,-a++ be &arr$ed 3"' d"r$/0 r3"'$/e pr3d"&'$3/ 36 pr3d"&', $/'e/ded 63r ,a+e. 43/&"rre/'(a+$da'$3/ ,-a++ be d3/e *-e/ -$. T-ere $, &-a/0e $/ pr3&e,, 3r e;"$p#e/' 63r a/ e%$,'$/0 pr3d"&'. $$. T-e pr3d"&' $, #a/"6a&'"red (er $/6re;"e/'+.$$$. E,'ab+$,-ed Pr3d"&', 63r *-$&- Va+$da'$3/ -a, /3' bee/ d3/e pr3,pe&'$(e+.Documentat$on: T-e da'a 63r '-e 43/&"rre/' (a+$da'$3/ ,-a++ a' +ea,' &3#pr$,e 36 7 ,e', 36 da'a'-a' are &3/,e&"'$(e a/d are a re,"+' 36 a &3#p+e'ed e%er&$,e. Retrospect$%e Va*$dat$on: I' ,-a++ be &arr$ed 3"' 63r a pr3d"&'? *-$&- -a, bee/ #arDe'ed ba,ed "p3/ a&&"#"+a'ed#a/"6a&'"r$/0? 'e,'$/0 a/d &3/'r3+ 'e,' da'a. Re'r3,pe&'$(e (a+$da'$3/ ,-a++ be d3/e *-e/-$. T-e S,'e# -a, bee/ ,'ab$+$Ced a/d /3 &-a/0e, are re;"$red 63r '-e ,,'e#.$$. T-e S,'e# &3#p3/e/', ($C.E;"$p#e/'? :'$+$'$e,? Fa&$+$'$e, are ;"a+$6$ed a, per '-e ,'a/dard/3r#,.$$$. T-e $/'erre+a'ed ,,'e#, ,"&- a, A/a+'$&a+ Me'-3d, 3r 4+ea/$/0 Me'-3d, 3r Pr3&e,,e, are(a+$da'ed. Documentat$on:T-e da'a 63r '-e Re'r3,pe&'$(e (a+$da'$3/ ,-a++ a' +ea,' &3#pr$,e 36 20 ,e', 36da'a'-a' are &3/,e&"'$(e*$'-/3 &-a/0e $/ '-e ,,'e# e$'-er$/1ard*are a,pe&' 3rS36'*area,pe&' a/d are a re,"+' 36 a &3#p+e'ed e%er&$,e. I6 '-e pr3d"&' $, /3' #a/"6a&'"red r3"'$/e+ '-e/#$/$#"# 10 ,e', 36 da'a &a/ be &3/,$dered 3/+ a6'er a"'-3r$Ca'$3/ 36 Va+$da'$3/ Tea#. Document No.ALB/F/VMP/001-01ALEMBIC LIMITED BADDISupersede:ALB/F/VMP/001-00VALIDATION MASTER PLAN Pageo! "#E!!ect$%e Date15.11.2005&'ALIT( ASS'RANCE DEPARTMENT Re%$e) Date14.11.2007".8 Re%a*$dat$on: Fa&$+$'$e,? ,,'e#,? e;"$p#e/' a/d pr3&e,,e,? $/&+"d$/0 &+ea/$/0 ,-3"+d be per$3d$&a++ e(a+"a'ed'3&3/6$r#'-a' '-ere#a$/(a+$da'ed'-ere$,/3,$0/$6$&a/' &-a/0e,-a(ebee/#ade'3'-e(a+$da'ed ,'a'",? a re($e* *$'- e($de/&e '-a' 6a&$+$'$e,? ,,'e#,? e;"$p#e/' a/d pr3&e,, #ee' '-epre,&r$bed re;"$re#e/', 6"+6$+, '-e /eed63r re(a+$da'$3/. Re-(a+$da'$3/ ,-a++ &3/,$der "/der63++3*$/0 &3/,$dera'$3/> 4-a/0e $/ &r$'$&a+ &3#p3/e/' @a&'$(e $/0red$e/',? e%&$p$e/',? 3r pr$#ar pa&Da0$/0A. 4-a/0e 3r rep+a&e#e/' $/ &r$'$&a+ par', 36 '-e e;"$p#e/'? *-$&- #a a66e&' '-e ;"a+$' 36'-e pr3d"&'. S$0/$6$&a/' &-a/0e $/ pr3&e,, &3/d$'$3/, '-a' #a a66e&' ,"b,e;"e/' "/$' 3pera'$3/, a/d pr3d"&' ;"a+$'. S$0/$6$&a/' &-a/0e $/ '-e ba'&- ,$Ce '-a' a66e&' '-e 3pera'$3/ 36 '-e #3d"+ar e;"$p#e/'. Fa$+"re 36 ,e;"e/'$a+ ba'&-e, '3 #ee' pr3d"&' a/d pr3&e,, ,pe&$6$&a'$3/,.T-e 4r$'$&a+? Ma23r5 M$/3r &-a/0e, ,-a++ be &+a,,$6$ed a, 63++3*,> Cr$t$ca*:4r$'$&a+ &-a/0e, are'-3,e&-a/0e, '-a' are+$De+'3-a(ea,$0/$6$&a/' $#pa&' 3/63r#"+a'$3/? )"a+$' a/d Per63r#a/&e.Ma1or:Ma23r &-a/0e, are '-3,e&-a/0e,'-a' &3"+d -a(e a,$0/$6$&a/'$#pa&'3/ 63r#"+a'$3/?)"a+$' a/d Per63r#a/&e.M$nor:M$/3r &-a/0e, are'-3,e&-a/0e, '-a' are"/+$De+'3-a(ea,$0/$6$&a/' $#pa&' 3/63r#"+a'$3/? )"a+$' a/d Per63r#a/&e.Document No.ALB/F/VMP/001-01ALEMBIC LIMITED BADDISupersede:ALB/F/VMP/001-00VALIDATION MASTER PLAN Page " o! "#E!!ect$%e Date15.11.2005&'ALIT( ASS'RANCE DEPARTMENT Re%$e) Date14.11.20075.7 VALIDATION APPROAC2:T-e appr3a&- 63r Va+$da'$3/ ,-a++ ba,ed 3/ '-e HV M3de+I a, ,-3*/ $/ d$a0ra#.5. 'ser Re:De,$0/ ,pe&$6$&a'$3/ @DSA ,-a++ de6$/e '-e de,$0/ ,pe&$6$&a'$3/, 36 '-e ,,'e#/,,'e# &3#p3/e/'a/d ,-a++ de'a$+ '-e &3/,&$3", de&$,$3/, $/ '-e ,e+e&'$3/ 36 '-e ,"pp+$er. 5.6 Stages o! &ua*$!$cat$on> )"a+$6$&a'$3/ ,-a++ &3(er '-e 63++3*$/0 area,> De,$0/ )"a+$6$&a'$3/ @D)A I/,'a++a'$3/ )"a+$6$&a'$3/ @I)A Opera'$3/a+ )"a+$6$&a'$3/ @O)A Per63r#a/&e )"a+$6$&a'$3/ @P)A5.6. Des$gn &ua*$!$cat$on:De,$0/ )"a+$6$&a'$3/ @D)A $, d3&"#e/'ed (er$6$&a'$3/ '-a' '-e pr3p3,ed de,$0/ 36 '-e 6a&$+$'$e,?e;"$p#e/'? 3r ,,'e#, $, ,"$'ab+e 63r '-e $/'e/ded p"rp3,e a/d '3 #ee' '-e &BMP re;"$re#e/',.5.6." Insta**at$on &ua*$!$cat$on:I/,'a++a'$3/ ;"a+$6$&a'$3/ @I)A $, d3&"#e/'ed (er$6$&a'$3/ '-a' '-e 6a&$+$'$e,? ,,'e#, a/de;"$p#e/'? a, $/,'a++ed 3r #3d$6$ed? &3#p+ *$'- '-e appr3(ed de,$0/ 3r #a/"6a&'"rerJ,re&3##e/da'$3/,. F3++3*$/0 a&'$($'$e, ,-a++ be &arr$ed 3"' d"r$/0 e%e&"'$3/ 36 I)-1. I/,'a++a'$3/36 e;"$p#e/'? p$p$/0? ,er($&e, a/d$/,'r"#e/'a'$3/,-a++ be&-e&Deda,perappr3(ed de,$0/ a/d ,pe&$6$&a'$3/.2. S"pp+$erJ,SOP3r *3rDI/,'r"&'$3/, a/dde'a$+, 36 #a$/'e/a/&ere;"$re#e/', ,-a++ be&3++e&'ed a/d &3++a'ed.Document No.ALB/F/VMP/001-01ALEMBIC LIMITED BADDISupersede:ALB/F/VMP/001-00VALIDATION MASTER PLAN Page 6 o! "#E!!ect$%e Date15.11.2005&'ALIT( ASS'RANCE DEPARTMENT Re%$e) Date14.11.20077. Ma'er$a+ 36 &3/,'r"&'$3/36 a++ &3#p3/e/', ,-a++ be(er$6$ede$'-er ba/a+,$, 3r b3b'a$/$/0 'e,'$/0 &er'$6$&a'e, 6r3# (e/d3r $,,"ed b ,"$'ab+e a0e/&$e, 4. A++ a''a&-ed $/,'r"#e/', ,-a++ be &-e&Ded 63r &a+$bra'$3/ ,'a'", a/d &a+$bra'$3/ &er'$6$&a'e,36 '-3,e $/,'r"#e/', ,-a++ be &3#p$+ed.5.6.5 Operat$ona* &ua*$!$cat$on:Opera'$3/a+ )"a+$6$&a'$3/ @O)A $, d3&"#e/'ed (er$6$&a'$3/ '-a' '-e e;"$p#e/' / ,,'e#, 3r ,"b-,,'e# a, $/,'a++ed 3r #3d$6$ed? per63r# a, $/'e/ded '-r3"0-3"' a++ a/'$&$pa'ed 3pera'$/0 ra/0e,.O) ,-a++ &-e&D '-a' '-e $/,'a++ed ,,'e#, $/ ,"pp3r' 36 ea&- 3'-er are $/ a ,'a'e 36 read$/e,, 63r'-e $/'e/ded 3pera'$3/ a/d *-$+e ",e ,-a++ pr3d"&e a/ e/d re,"+' a, &3/&e$(ed a' '-e ,'a0e 36de,$0/$/0. T-e ,,'e# ,-a++ be &-e&Ded 63r "pper a/d +3*er 3pera'$/0 +$#$'. A' +ea,' dra6' 63r# 36'-e SOP 63r '-e e;"$p#e/'/,,'e# ,-a++ be #ade read a' '-$, ,'a0e.5.6.6. Per!ormance &ua*$!$cat$on:Per63r#a/&e)"a+$6$&a'$3/@P)A $,d3&"#e/'ed(er$6$&a'$3/'-a' '-ee;"$p#e/' a/da/&$++ar,,'e#,? a, &3//e&'ed'30e'-er? &a/per63r#e66e&'$(e+a/drepr3d"&$b+a, $/'e/ded"/der/3r#a+ 3pera'$/0 e/($r3/#e/'.P) ,-a++ be d3/e ",$/0 pr3d"&'$3/ #a'er$a+? ;"a+$6$ed ,"b,'$'"'e, 3r ,$#"+a'ed pr3d"&' a/d '-e,"$'ab$+$'36'-e,,'e#$,e,'ab+$,-ed'30$(ede,$red3"'p"' *-e/3pera'ed"/der,pe&$6$ed3pera'$/0 para#e'er,. T-$, #a be &arr$ed 3"' a, a par' 36 Pr3&e,, (a+$da'$3/.5.# Bas$s o! Acceptance:5.#. @actor3 Acceptance Test:T-e 6a&'3r A&&ep'a/&e Te,' @FATA ,-a++ be &3/d"&'ed a' '-e #a/"6a&'"rerJ, ,$'e b a#"+'$d$,&$p+$/ar'ea#@&3#pr$,$/036)"a+$'? Pr3d"&'$3/a/dE/0$/eer$/0per,3//e+Ad"r$/0d$66ere/' ,'a0e,36a,,e#b+/6abr$&a'$3/'-e,,'e#'3e/,"re'-e6$'/e,,36'-ee/'$'63r'-e$/'e/ded ",e. FAT e%er&$,e $, ba,$&a++ a Pre-;"a+$6$&a'$3/.T-e S'a0e, 36 $/,pe&'$3/ *3"+d be de&$ded a' '-e '$#e 36 re+ea,$/0 P"r&-a,e 3rder. Document No.ALB/F/VMP/001-01ALEMBIC LIMITED BADDISupersede:ALB/F/VMP/001-00VALIDATION MASTER PLAN Page # o! "#E!!ect$%e Date15.11.2005&'ALIT( ASS'RANCE DEPARTMENT Re%$e) Date14.11.2007F3++3*$/0 de'a$+, ,-a++ be &3(ered d"r$/0 FAT- :,er Re;"$re#e/' ,pe&$6$&a'$3/ /P"r&-a,e 3rder re;"$re#e/'. 4r$'$&a+ &3#p3/e/', @43/'a&' par',A ,'a#p$/0 a/d a/a+,$,. Pre-6$/$,- $/,pe&'$3/. F$/a+ I/,pe&'$3/ a' (e/d3r ,$'e Appr3(a+ b '-e $/,pe&'$3/ 'ea#. P5 ID (er$6$&a'$3/. BA Dra*$/0 (er$6$&a'$3/.RemarAs: @actor3 Acceptance Test s.a** not +e carr$ed out $! t.e eTpe 36 a/a+'$&a+pr3&ed"re 4-ara&'er$,'$&, Ide/'$6$&a'$3/ Te,'$/0 63r $#p"r$'$e, A,,a - D$,,3+"'$3/@ Mea,"re#e/' 3/+ A- 43/'e/' / P3'e/&Quantitation. Limit A&&"ra&- K - KPre&$,$3/ Repea'ab$+$'- K - K I/'er#ed$a'ePre&$,$3/ - K@1A - K@1ASpe&$6$&$' @2A K K K KDe'e&'$3/ +$#$'- -@7A K -)"a/'$'a'$3/ +$#$'- K - -L$/ear$'- K - KRa/0e- K - K- S$0/$6$e, '-a' '-$, &-ara&'er$,'$& $, /3r#a++ /3' e(a+"a'ed.K S$0/$6$e, '-a' '-$, &-ara&'er$,'$& $, /3r#a++ e(a+"a'ed.@1A I/ &a,e *-ere repr3d"&$b$+$' -a, bee/ per63r#ed. I/'er#ed$a'e pre&$,$3/ $, /3' /eeded.@2A La&D 36 ,pe&$6$&$' 36 3/e a/a+'$&a+ pr3&ed"re &3"+d be &3#pe/,a'ed b 3'-erS"pp3r'$/0 a/a+'$&a+ pr3&ed"re.@7A Ma be /eeded $/ ,3#e &a,e,.A6'er '-e (a+$da'$3/ 36 A/a+'$&a+ #e'-3d? $' $, 'ra/,6erred '3 re,pe&'$(e ,$'e 3/ '-e ba,$, 36 '-e$r re;"$re#e/' b '-e Per,3//e+ 6r3# A/a+'$&a+ De(e+3p#e/' Lab3ra'3r. Document No.ALB/F/VMP/001-01ALEMBIC LIMITED BADDISupersede:ALB/F/VMP/001-00VALIDATION MASTER PLAN Page 9 o! "#E!!ect$%e Date15.11.2005&'ALIT( ASS'RANCE DEPARTMENT Re%$e) Date14.11.2007Re%a*$dat$on>Re(a+$da'$3/ #a be /e&e,,ar $/ '-e 63++3*$/0 &$r&"#,'a/&e,> 4-a/0e, $/ &r$'$&a+ ra* #a'er$a+, 4-a/0e, $/ '-e Ma/"6a&'"r$/0 Pr3&e,, /F3r#"+a. 4-a/0e, $/ '-e &3#p3,$'$3/ 36 '-e F$/$,-ed Pr3d"&'. 4-a/0e, $/ '-e a/a+'$&a+ pr3&ed"re.T-e de0ree 36 Re(a+$da'$3/ re;"$red ,-a++ depe/d 3/ '-e /a'"re 36 '-e &-a/0e,. #.7 CLEANIN? VALIDATION:4+ea/$/0 (a+$da'$3/ ,-a++ be &arr$ed 3"' '3 e,'ab+$,- d3&"#e/'ed e($de/&e *-$&- ,-a++ pr3d"&e a-$0- de0ree 36 a,,"ra/&e '-a' '-e &+ea/$/0 pr3&ed"re ad3p'ed 63r &+ea/$/0 36 #a/"6a&'"r$/0 a/dpr3&e,,$/0 e;"$p#e/', are ade;"a'e a/d repr3d"&$b+e '3 '-e a&&ep'ab+e +e(e+ 36 pre($3", pr3d"&'3r &arr3(er 36 '-e re,$d"e,.C*ean$ng %a*$dat$on stud$es s.a** compr$se o!:5.1 Se+e&'$3/ 36 &a/d$da'e 63r Pr3d"&'/E;"$p#e/' Br3"p$/0>5.2 =3r,' &a,e ,e+e&'$3/ 3/ '-e ba,$, 36 '-e 63++3*$/0>5.2.1 S3+"b$+$' 5.2.2 D3,a0e @ S're/0'-A5.2.7 Ba'&- S$Ce,5.2.4 D$66$&"+' '3 &+ea/ 5.2.5 1$0-p3'e/' Dr"0, 5.7 De(e+3p#e/' 36 &+ea/$/0 #e'-3d 63r '-e pr3,pe&'$(e ,'"d$e,.5.4 Sa#p+$/0 #e'-3d a/d $', re&3(er.5.5 A/a+'$&a+ #e'-3d (a+$da'$3/.5.8 De'er#$/a'$3/ 36 MA4 @Ma%$#"# A++3*ab+e &arr3(erA.5.7 4+ea/$/0 (a+$da'$3/ rep3r'? ,"##ar a/d &3/&+",$3/. Document No.ALB/F/VMP/001-01ALEMBIC LIMITED BADDISupersede:ALB/F/VMP/001-00VALIDATION MASTER PLAN Page : o! "#E!!ect$%e Date15.11.2005&'ALIT( ASS'RANCE DEPARTMENT Re%$e) Date14.11.2007 Acceptance Cr$ter$a>1. T-e e;"$p#e/' ,-3"+d be ($,"a++ &+ea/.2. N3' #3re '-a/ 0.1L 36 '-e #$/$#"# d3,e 36 '-e re,$d"e a&'$(e $/ '-e #a%$#"# d3,e 36 '-e/e%' pr3d"&'. 3.10 PPM 4r$'er$a. Re/%a*$dat$on cr$ter$a: =-e/e(er '-ere $, &-a/0e $/ '-e 4+ea/$/0 Me'-3d3+30 A/ add$'$3//de+e'$3/ $/ '-e +$,' 36 E;"$p#e/'. $/'r3d"&'$3/ 36 /e* pr3d"&' $/'-e pr3d"&' 0r3"p. F3r#"+a/#a/"6a&'"r$/0 pr3&e,, 36 a/ pr3d"&' $/ pr3d"&' 0r3"p? *-$&- #a a66e&' '-e ,'a'", 36 4+ea/$/0 Va+$da'$3/.8.7 PROCESS VALIDATION>Pr3&e,, (a+$da'$3/ $, e,'ab+$,-$/0 d3&"#e/'ed e($de/&e,? *-$&- pr3($de, a -$0- de0ree 36a,,"ra/&e '-a' a ,pe&$6$& pr3&e,, ,-a++ &3/,$,'e/'+ pr3d"&e a pr3d"&' #ee'$/0 $', prede'er#$/ed,pe&$6$&a'$3/, 5;"a+$' &-ara&'er$,'$&,. Pr3&e,, (a+$da'$3/ ,-a++ be &arr$ed 3"' 63r '-e dr"0pr3d"&',? *-$&-arebe$/0#a/"6a&'"red63r '-e6$r,' '$#e a' '-e+3&a'$3/. Pr3&e,, (a+$da'$3/pr3'3&3+ ,-a++ be ba,ed 3/ '-e Ma,'er d3&"#e/' 36 '-e pr3d"&'. T-e (a+$da'$3/ ,'"d$e, ,-a++ be ba,ed "p3/ '-e '-ree &3/,e&"'$(e ba'&-e, 36 '-e pr3d"&'#a/"6a&'"red b '-e ,a#e #a/"6a&'"r$/0 pr3&e,,? "/der $de/'$&a+ &3/d$'$3/, a/d ",$/0 3/e ,e' 3re;"$(a+e/' 36 e;"$p#e/'? &3/'r3++$/0 '-e &r$'$&a+ pr3&e,, para#e'er,.T-ree ba'&-e, ,-a++ be'e,'ed63r &3#p+$a/&e '3'-epre-de'er#$/ed,pe&$6$&a'$3/? *-$&-a+,3$/&+"de, $/-pr3&e,, ,a#p+$/0 a/d 'e,'$/0.O/&e '-e pr3&e,, 0e', (a+$da'ed? $' -a, '3 be #a$/'a$/ed '3 pr3d"&e a pr3d"&' &3/,$,'e/'+ '3 #ee''-e prede'er#$/ed ;"a+$' a''r$b"'e,.Document No.ALB/F/VMP/001-01ALEMBIC LIMITED BADDISupersede:ALB/F/VMP/001-00VALIDATION MASTER PLAN Page ; o! "#E!!ect$%e Date15.11.2005&'ALIT( ASS'RANCE DEPARTMENT Re%$e) Date14.11.2007Re/%a*$dat$on Cr$ter$a> Re-(a+$da'$3/ $, re;"$red? $6 1. 4-a/0e $/ 4r$'$&a+ #a/"6a&'"r$/0 e;"$p#e/'.2. 4-a/0e $/ #a/"6a&'"r$/0 pr3&e,,.3. 4-a/0e $/ Ba'&- ,$Ce a/d F3r#"+a.4. 4-a/0e $/ S3"r&e 36 ra* #a'er$a+. @A&'$(e a/d &r$'$&a+ $/a&'$(e #a'er$a+ A9.7 @ACILIT( &'ALI@ICATION:De,$0/ ;"a+$6$&a'$3/ @D)A ,-3"+d be &arr$ed 3"' '3 6$/a+$Ce '-e 6a&$+$' a&&3rd$/0 '3 Prede'er#$/ed de,$0/ ,pe&$6$&a'$3/. De,$0/ )"a+$6$&a'$3/ $, a (a+$da'$3/ 'a,D '3 e/,"re '-a' a++ '-e&BMP re0"+a'3r a,pe&' -a(e bee/ &3(ered $/ '-e de,$0/ ba,e, a/d '-e 6a&$+$' de,$0/ are a, per$/'e/ded ",e.D) ,-a++ be &arr$ed 3"' '3 e(a+"a'e '-e 6a&$+$' a&&3rd$/0 '3 prede'er#$/ed de,$0/ re;"$re#e/',.F3++3*$/0 p3$/', ,-a++ be &3(ered $/ '-e De,$0/ )"a+$6$&a'$3/ -1. Ra'$3/a+e 63r de,$0/ 2. Ba,$, 36de,$0/ 7. Area ,pe&$6$& de,$0/. @Ma/"6a&'"r$/0? )"a+$'&3/'r3+? *are-3",e a/dAd#$/$,'ra'$3/b+3&D.A4. 43/,'r"&'$3/ a/d 6$/$,-e, de'a$+, +$De F+33r? *a++? &e$+$/0? &3($/0? *$/d3*? d33r, e'&. 5. :'$+$' ,er($&e,. E+e&'r$&a+ 1VA4 ,,'e# =a'er ,,'e# 43#pre,,ed a$r.8. L30$,'$&, a/d Ad#$/$,'ra'$(e a&'$($'.7. Per,3//e+ a/d #a'er$a+ #3(e#e/'.
I' pr3($de, d3&"#e/'ed e($de/&e '-a' '-e de,$0/ 36 '-e ,,'e# $, ,"$'ab+e 63r '-e $/'e/ded p"rp3,ea/d $, &apab+e 36 pr3d"&$/0 p"r$6$ed *a'er #ee'$/0 a++ ;"a+$' a/d &BMP re;"$re#e/', a, de6$/ed$/ ",er re;"$re#e/' ,pe&$6$&a'$3/.Insta**at$on &ua*$!$cat$on =I&>D3&"#e/'a'$3/ '-a' '-e ,,'e# $, &3/,'r"&'ed a&&3rd$/0 '3 '-e ,pe&$6$& de,$0/ $/ 'er#, 36 ,'a'$&a''r$b"'e,. A++ '-e $/d$($d"a+ &3#p3/e/', ,-a++ be &-e&Ded d"r$/0 I) a, per appr3(ed de,$0/.Operat$on &ua*$!$cat$on =O&>D3&"#e/'a'$3/ '-a' a ,,'e#3r ,"b-,,'e#per63r#, a, $/'e/ded *-e/ &3#pared '3 aprede'er#$/ed ,e' 36d3nam$ca''r$b"'e,. D/a#$& a''r$b"'e, ,-a++ $/&+"de &3/63r#a/&e '3per63r#a/&e ,pe&$6$&a'$3/, ,"&- a, *a'er 6+3* (e+3&$'? ,a/$'$Ca'$3/ re;"$re#e/',? e'&.Per!ormance &ua*$!$cat$on =P&>D3&"#e/'a'$3/ '-a' a ,,'e#3r ,"b-,,'e#per63r#, a, $/'e/ded a/d #ee', a++ '-e :,erRe;"$re#e/',. D"r$/0P)&-e#$&a+ a/d#$&r3b$3+30$&a+ para#e'er, 36 p"r$6$ed*a'er ,-a++ bea/a+,ed '-3r3"0-+ $/ '-ree p-a,e.5 P.ase Approac. !or t.e P&T-e P) ,-a++ 'aDe p+a&e $/ '-ree p-a,e,. T-ere ,-a++ be p-a,e,-I 63r 4 *eeD,? P-a,e-II 63r 4 *eeD,a/d P-a,e-III 63r 10 #3/'- d"r$/0 '-$, '-e *a'er ,-a++ be #3/$'3red? &-e#$&a++ a/dDocument No.ALB/F/VMP/001-01ALEMBIC LIMITED BADDISupersede:ALB/F/VMP/001-00VALIDATION MASTER PLAN Page " o! "#E!!ect$%e Date15.11.2005&'ALIT( ASS'RANCE DEPARTMENT Re%$e) Date14.11.2007#$&r3b$3+30$&a++. T-e 12 #3/'- per$3d ,-a++ e/ab+e '-e per63r#a/&e 36 '-e ,,'e# '3 be ;"a+$6$ed@'aD$/0 ,ea,3/a+ (ar$a'$3/, $/'3 a&&3"/'A.Test Summar3 4 Conc*us$on !or t.e P&T-e ,"##ar$e, 36 '-e 4-e#$&a+ a/d #$&r3b$a+ 'e,'$/0 ,-a++ be &3#p+e'ed 63r ea&- p-a,e 36 '-e P).O/&eap-a,e$,&3#p+e'ed? a&3/&+",$3/,-a++ be*r$''e/$/d$&a'$/0*-e'-er'-e4-e#$&a+ a/dM$&r3 ,pe&$6$&a'$3/, are &3#p+$/0 *$'- '-e pre-,e' &r$'er$a.;.7 2VAC S(STEM VALIDATION1ea'$/0 (e/'$+a'$3/ a/d a$r E&3/d$'$3/$/0 @1VA4A ,,'e# are ",ed '3 &3/'r3+ '-e +e(e+ 36 ($ab+ea/d /3/- ($ab+e par'$&"+a'e e%p3,"re '-a' a dr"0 re&e$(e, $/ add$'$3/ '3 re0"+a'$/0 'e#pera'"re a/dre+a'$(e -"#$d$' &3/d$'$3/, b #a$/'a$/$/0 re;"$red r33# pre,,"re a/d a$r &-a/0e,. T-e appr3a&-63r ;"a+$6$&a'$3/ ,-a++ be a, 63++3*,-Des$gn &ua*$!$cat$onDe,$0/ )"a+$6$&a'$3/ $, pr3($d$/0 d3&"#e/'ed e($de/&e '-a' '-e de,$0/ 36 '-e ,,'e# $, ,"$'ab+e 63r'-e $/'e/ded p"rp3,e. Para#e'er, +$De 6$+'ra'$3/,'a/dard?a$r6+3*d$re&'$3/? a$r &-a/0e ra'e,?e'&,-a++ be &3/,$dered 3/ &BMP p3$/' 36 ($e* a/d 63r $/'e/ded p"rp3,e '3 prepare '-e D) d3&"#e/'. Insta**at$on &ua*$!$cat$on =I&>A++ '-e $/d$($d"a+ &3#p3/e/', ,-a++ be &-e&Ded d"r$/0 I) a, per appr3(ed de,$0/.Operat$on &ua*$!$cat$on =O&>O) ,-a++ &-e&D '-a' '-e $/,'a++ed ,,'e# $/ ,"pp3r' 36 ea&- 3'-er $, $/ ,'a'e 36 read$/e,, 63r '-e$/'e/ded 3pera'$3/ a/d *-$+e ",e ,-a++ pr3d"&e a/ e/d re,"+' a, &3/&e$(ed a' '-e ,'a0e 36 de,$0/$/0.F3++3*$/0 para#e'er, ,-a++ be &arr$ed 3"' d"r$/0 O)- Opera'$3/a+ Pr3&ed"re 43#p+$a/&e Te,' L3&a+ 43/'r3+ Pa/e+ Opera'$3/ Te,' Te#pera'"re 5 R1 #3/$'3r$/0 Document No.ALB/F/VMP/001-01ALEMBIC LIMITED BADDISupersede:ALB/F/VMP/001-00VALIDATION MASTER PLAN Page "" o! "#E!!ect$%e Date15.11.2005&'ALIT( ASS'RANCE DEPARTMENT Re%$e) Date14.11.2007 D$66ere/'$a+ A$r pre,,"re 5 d$re&'$3/ Te,'. A$r 4-a/0e Ra'e DOP Te,'Per!ormance &ua*$!$cat$on =P&>D3&"#e/'a'$3/ '-a' a ,,'e#3r ,"b-,,'e#per63r#, a, $/'e/ded a/d #ee', a++ '-e :,erRe;"$re#e/',. T-e P) ,-a++ $/&+"de '-e 63++3*$/0 '3p$&,> N3/-($ab+e Par'$&"+a'e &3"/' V$ab+e Par'$&"+a'e &3"/' S"##ar 5 43/&+",$3/7.7COMPRESSED AIR S(STEM &'ALI@ICATION 43#pre,,3r $, $/,'a++ed '3 ,"pp+ 3$+ 6ree @N3/-+"br$&a'edA 'pe 36 a$r '3 3pera'e '-e (ar$3", e;"$p#e/' a/d #e&-a/$&a+ app+$&a'$3/ +$De p/e"#a'$& (a+(e a&'"a'$3/ e'&.Per63r#a/&e )"a+$6$&a'$3/ @P)A>D"r$/0 P)? Per63r#a/&e &-e&D, ,-a++ be per63r#ed *-ere '-e &3#pre,,ed a$r ,-a++ d$re&'+ &3#e $/'3 &3/'a&' *$'- '-e pr3d"&' e.0. Rap$d M$%er Bra/"+a'3r? A"'3 &3a'er e'&. a/d 63++3*$/0 para#e'er, ,-a++ be &-e&Ded a' '-e p3$/' 36 ",e. O$+ #$,' 'e,'. M$&r3b$a+ 'e,'.Document No.ALB/F/VMP/001-01ALEMBIC LIMITED BADDISupersede:ALB/F/VMP/001-00VALIDATION MASTER PLAN Page "5 o! "#E!!ect$%e Date15.11.2005&'ALIT( ASS'RANCE DEPARTMENT Re%$e) Date14.11.2007.7COMP'TER S(STEM VALIDATION>43#p"'er$Ced ,,'e#, +$/Ded 3pera'$3/, are ",ed $/ #a/"6a&'"r$/0? "'$+$' a/d ;"a+$' 6"/&'$3/,.S36'*are a/d a&&e,,3r$e, *-$&- -a, d$re&' $#pa&' 3/ '-e ;"a+$' 36 pr3d"&' ,-a++ be &3(ered 63r(a+$da'$3/. T-e,e $/&+"de- PL4 $/ 4r$'$&a+ Pr3&e,, E;"$p#e/' $/ &a,e app+$&ab+e. Da'a a&;"$,$'$3/ ,,'e# $/ *a'er ,,'e#. S36'*are 63r &r$'$&a+ I/,'r"#e/' $/ )"a+$' 6"/&'$3/. Ma'er$a+ $/(e/'3r ,,'e#Depe/d$/0 "p3/ app+$&ab$+$'? (a+$da'$3/ e%er&$,e *$++ &3(er '-e 'e,' 63r da'a a&;"$,$'$3/? ,,'e# ,e&"r$'? a&&e,, &3/'r3+? a"d$' 'ra$+? (a+$d$' 36 da'a? e'&.".7:VALIDATION SC2ED'LE:A//e%"re-I > Pr3&e,, e;"$p#e/' A//e%"re-II > Lab3ra'3r $/,'r"#e/' A//e%"re-III > :'$+$' )"a+$6$&a'$3/ A//e%"re-IV > Pr3&e,, (a+$da'$3/ a/d &+ea/$/0 (a+$da'$3/ A//e%"re-V > 43#p"'er ,,'e# (a+$da'$3/ S'a'", 36 Va+$da'$3/ S&-ed"+e *$++ be re&3rded a/d re($e*ed a//"a++ '3 e/,"re '-a' '-e Va+$da'$3/ A&'$($' $, pr30re,,$/0 a, per p+a/ a/d pr$3r$' a/d '3 $de/'$6 a/d a&'$(a'e '-e /eed '-a' $, re;"$red '3 be addre,,ed.Document No.ALB/F/VMP/001-01ALEMBIC LIMITED BADDISupersede:ALB/F/VMP/001-00VALIDATION MASTER PLAN Page "6 o! "#E!!ect$%e Date15.11.2005&'ALIT( ASS'RANCE DEPARTMENT Re%$e) Date14.11.20075.7. S'PPORTIN? PRO?RAMST-eVMP$,#ea/' '3beaVa+$da'$3/L$6e4&+ed3&"#e/'. I' '-",&3(er, '-ea&'$($'$e, a/dre;"$re#e/', 6r3# pr32e&' $/&ep'$3/ '3 'e,'$/0 &3#p+e'$3/ a/d 3/ '-r3"0- a pr30ra# 36 &3/'$/"3",#3/$'3r$/0a/de(a+"a'$3/. A,,3&$a'ed*$'-'-$, e663r' are)"a+$'A,,"ra/&e/)"a+$'&3/'r3+pr3&ed"re, #ea/' '3 ,"pp3r' a/d "pda'e '-e (a+$da'$3/ e663r'. T-e,e pr30ra#, $/&+"de '-e63++3*$/0>Document 4C.ange contro*:A pr3&ed"re #",' be $/ p+a&e '3 03(er/ a/d &ap'"re d3&"#e/'a'$3/ &rea'$3/? re($,$3/ a/d &3/'r3+.T-$, pr3&ed"re ,-a++ be app+$&ab+e '3 a++ (a+$da'$3/ d3&"#e/'a'$3/ a/d #",' de,$0/a'e '-e re($e*a/d appr3(a+ re,p3/,$b$+$'$e, 36 (ar$3", 6"/&'$3/a+ 0r3"p,. Ar&-$(a+ 0"$de+$/e, ,-a++ $/&+"ded"ra'$3/ 36 re&3rd re'e/'$3/? a/d #ea/, 36 ,'3ra0e a/d re'r$e(a+.Standard Operat$ng Procedures:SOP, ,-3"+d e%$,' '3 addre,, ,"&- &BMP $,,"e, a, 6a&$+$' ,a/$'a'$3/? *a,'e &3++e&'$3/ a/d d$,p3,a+?'-e ",e36 ,"$'ab+e r3de/'$&$de,? $/,e&'$&$de,? 6"/0$&$de, a/d6"#$0a'$/0a0e/',? a/db"$+d$/0#a$/'e/a/&e.Ca*$+rat$on:A,,'e#,-3"+de%$,' de'a$+$/0'-e#e'-3d,? 6re;"e/&a/dd3&"#e/'a'$3/36 '-e&a+$bra'$3/pr30ra# $/&+"d$/0 2",'$6$&a'$3/ 63r a H/3 &a+$bra'$3/ re;"$redI ,'a'",.Pre%entat$%e Ma$ntenance:T-$, ,,'e#,-3"+dbe$/de%ed'3d$,'$/&' e;"$p#e/' $de/'$6$er, a/d3"'+$/e'-e#a$/'e/a/&epr3&ed"re, re;"$red '3e/,"re pr3per ,,'e#6"/&'$3/a+$'. T-$, pr3&ed"re ,-a++ $de/'$6 '-eappr3pr$a'e d3&"#e/'a'$3/ a/d 6re;"e/& re;"$re#e/',.Document No.ALB/F/VMP/001-01ALEMBIC LIMITED BADDISupersede:ALB/F/VMP/001-00VALIDATION MASTER PLAN Page "# o! "#E!!ect$%e Date15.11.2005&'ALIT( ASS'RANCE DEPARTMENT Re%$e) Date14.11.2007Tra$n$ng: A pr30ra# ,-3"+d e%$,' '3 e/,"re a/d d3&"#e/' '-a' per,3//e+ *$++ -a(e '-e appr3pr$a'e ed"&a'$3/?'ra$/$/0?a/d /3r e%per$e/&e '3 per63r# '-e$r a,,$0/ed 6"/&'$3/,. Per,3//e+ ,-3"+d be 'ra$/ed 3/033d ,a/$'a'$3/ pra&'$&e,? a, *e++ a, '-e ",e 36 pr3'e&'$(e appare+ '3 pre(e/' pr3d"&' &3/'a#$/a'$3/.6.7:RE@ERENCES: 14.1 P-ar#a&e"'$&a+ $/,pe&'$3/ &3/(e/'$3/ @ PI4/SA 0"$de+$/e - A"0G200114.2 Dra6' ;"a+$6$&a'$3/ a/d (a+$da'$3/ 0"$de+$/e, - E"r3pea/ &3##$,,$3/,-Ma/G2000. 14.7 ISPE 0"$de+$/e, 3/ )"a+$6$&a'$3/ a/d (a+$da'$3/ V3+. 5 14.4 S:PA4 0"$de+$/e, 14.5 P-ar#a&e"'$&a+ Pr3&e,, (a+$da'$3/? ,e&3/d ed$'$3/ V3+"#e 57 ed$'ed b R3ber'. A. Na,- / Ira R. Berr.14.8 I41 1ar#3/$Ced Tr$par'$'e B"$de+$/e-Te%' 3/ Va+$da'$3/ 36 A/a+'$&a+ Pr3&ed"re,.