Company Name & AddressPROCESS VALIDATION
PROTOCOL(CAPSULE)PROTOCOL NO: DATE OF EFFECTIVEFORMULATION :PRODUCT
NAME:LINE :REASON FOR PERFORMING THE VALIDATION STUD :Reason! "#$%
&'#$' e(er #s app)#$a*)e+ Remar%sDepar"men"New
productModifictio! i! t"e #!ufcturi!$ proce%%&C"!$e i! Fci'it(
!d ) or'octio! of #!ufcturi!$&*tc" fi' to #eet product +
proce%% %pecifictio!%&N,m*er o- *a"$'es
s",d#ed:,,,,,,,,,,,,,,,, .a"$' n,m*ers: -&
,,,,,,,,,,,,,,,.&& ,,,,,,,,,,,,,,,/&
,,,,,,,,,,,,,,,Va)#da"#on a$"#(#"y a,"'or#/ed .y:
,,,,,,,,,,,,,,,,,,,,,,,,,,,,,Dte:,,,,,,,,,,,,,,,,,,,,,,,Va)#da"#on
Team:DEPARTMENT VALIDATION TEAMPRODUCTION0UALIT1 ASSURANCE0UALIT1
CONTROLREMAR0S:,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,Prepred
2( C"ec3ed 2( Appro4ed 2(Company Name & AddressPROCESS
VALIDATION PROTOCOL(CAPSULE)PROTOCOL NO: DATE OF
EFFECTIVEAPPROVALS:DEPARTMENT SIGN & DATEPRODUCTION0UALIT1
ASSUARANCE0UALIT1 CONTROLPRODUCT DEVLOPMENTEN5INEERIN5123
GENERAL:-&- INTRODUCTION:T"eproce%%4'idtio!wi''
2eperfor#ed%pro%pecti4e4'idtio!& T"eco#p'etedocu#e!ttio! for
t"e 4'idtio! co#pri%e% %e4er' i!depe!de!t docu#e!t%6refere!ce% to
re'e4!t docu#e!t% wi'' 2e $i4e! % prt of t"i% protoco'6 (%ee
2e'ow)&T"e re%u't% of t"e 4'idtio! cti4itie% wi'' 2e %u##ri7ed
i! t"e 4'idtio! report&-&. Li%t of Docu#e!t%for V'idtio!:
V'idtio! protoco'6 Deti'% of %#p'i!$ for t"e 4'idtio! 2tc"e%6 te%t
pr#eter% ( Product perfor#!ce c"rcteri%tic%) wit" refere!ce to te%t
#et"od% + Accept!ce criteri&(ccept2'e Li#it) Met"od% for
recordi!$ ) e4'uti!$ re%u't% i!c'udi!$ %tti%tic' !'(%i%&
Refere!ce to re'e4!t docu#e!t%&-&.&. *tc" #!ufcturi!$
record%&Prepred 2( C"ec3ed 2( Appro4ed 2(Company Name &
AddressPROCESS VALIDATION PROTOCOL(CAPSULE)PROTOCOL NO: DATE OF
EFFECTIVE Deti'ed #!ufcturi!$ i!%tructio!% for t"e productio! of
t"e 4'idtio! 2tc"e%&423 PERSSONEL RESPONSI.ILITIES2SR ACTIVIT1
RESPONSI*ILIT1 REMAR8S- Preprtio! of 4'idtio! protoco'. Appro4' of
V'idtio! protoco'/ Productio! of 4'idtio! *tc"e%9 Te%ti!$ of
4'idtio! %#p'e% + Preprtio! of 4'idtio! report: Appro4' of 4'idtio!
report&/&; PROCESS DESCIRPTION ) FLO< S=EET T"e
i!for#tio! $i4e! 2e'ow pro4ide%$e!er' de%criptio! of t"e
proce%%& Deti'ed i!for#tio! for t"e #!ufcturi!$ wi'' 2e
%upp'ied %eprte'( i! t"e 2tc" #!ufcturi!$ record&-&;
DISPENSIN5 OF MATERIAL.&; S=IFTIN5/&; 5RANULATION (if
re>uired)&9&; *LENDIN5:&; MI?IN5@&; FILLIN5
A&; *LISTERIN5) STRIPPIN5)COUNTIN5& /&-
FORMULATION:*ATC= SIBE:Prepred 2( C"ec3ed 2( Appro4ed 2(Company
Name & AddressPROCESS VALIDATION PROTOCOL(CAPSULE)PROTOCOL NO:
DATE OF EFFECTIVESR IN5REDIENTS)E?CIPIENTS SPECIFICATION
M5&CAPS& PER *ATC= PER LOT-./9:@ACD-;---.-/NOTE:Prepred 2(
C"ec3ed 2( Appro4ed 2(Company Name & AddressPROCESS VALIDATION
PROTOCOL(CAPSULE)PROTOCOL NO: DATE OF EFFECTIVECAPSULE FLO5
CHARTPrepred 2( C"ec3ed 2( Appro4ed
2(R&M&DISPENSIN5S=IFTIN55RANULATION(IF RE0UIRED)COMPECT (IF
RE0UIRED)MILLIN5(IF RE0UIRED)FILLIN5*LISTER) STRIP
PAC8IN5)COUNTIN5MI?IN5FINAL PAC8IN50UARANTINEF&5&STORE*UL8
ANAL1SIS0UARANTINEFINIS=ED PRODUCT ANAL1SIS-& MI?IN5 TIME.&
SPEED*LENDIN5-& MI?IN5 TIME.& SPEED-&; uip#e!t u%ed for
4'idtio! to$et"er wit" t"e c'e!i!$ %ttu% wi'' 2e pro4ided i! t"e
#!ufcturi!$ docu#e!t%&9&- LIST OF SOPES 6 VALIDATION +
0UALIFICATION REPORT USED AS REFERENCESFSR ID2 NUM.ER TITLE
VERIFIED.DATE-&E>uip#e!t c'e!i!$ procedure for M%ter %ifter
G.;6G9;.&E>uip#e!t operti!$ procedure for M%ter %ifter
G.;6G9;/&E>uip#e!t c'e!i!$ procedure for Rpid #iHer
$r!u'tor&9&E>uip#e!t operti!$ procedure for Rpid #iHer
$r!u'tor&:&E>uip#e!t c'e!i!$ procedure for Oct$o!'
*'e!der&@&E>uip#e!t operti!$ procedure for Oct$o!'
2'e!der& A&E>uip#e!t c'e!i!$ procedure for cp%u'e
fi''i!$ #c"i!e&C&E>uip#e!t operti!$ procedure for cp%u'e
fi''i!$ #c"i!e&D&E>uip#e!t c'e!i!$ procedure for cp%u'e
po'i%"i!$ + C"ec3i!$ #c"i!e&-;&E>uip#e!t operti!$
procedure for cp%u'e po'i%"i!$ + C"ec3i!$
#c"i!e&--&E>uip#e!t c'e!i!$ procedure for %trip pc3i!$
#c"i!e&-.&E>uip#e!t operti!$ procedure for %trip pc3i!$
#c"i!e&-/&E>uip#e!t c'e!i!$ Procedure for *'i%ter Pc3i!$
#c"i!e&-9&E>uip#e!t operti!$ procedure for *'i%ter
Pc3i!$ #c"i!e&-:&E>uip#e!t c'e!i!$ procedure for Cp
cou!ti!$ #c"i!e-@&E>uip#e!t operti!$ procedure for Cp
cou!ti!$ #c"i!e-A&E>uip#e!t c'e!i!$ procedure for F'uid *ed
Dr(er&-C&E>uip#e!t operti!$ procedure for F'uid *ed
Dr(er&Prepred 2( C"ec3ed 2( Appro4ed 2(Company Name &
AddressPROCESS VALIDATION PROTOCOL(CAPSULE)PROTOCOL NO: DATE OF
EFFECTIVE-D&E!ter !( ot"er refere!ce %op&624 DETAILS OF
E7UIPMENT TO .E USED2E7UIPMENTDETAILSSIFTIN5 :T1PE
:MODEL:CAPACIT1:MANUACTURER:TA5&NO&:M&O&C&*LENDER:T1PE
:MODEL:CAPACIT1:MANUACTURER:TA5&NO&:M&O&C&MI?ER
:T1PE
:MODEL:CAPACIT1:MANUACTURER:TA5&NO&:M&O&C&MILLIN5T1PE
:MODEL:CAPACIT1:MANUACTURER:TA5&NO&:M&O&C&DR1IN5T1PE
:MODEL:Prepred 2( C"ec3ed 2( Appro4ed 2(Company Name &
AddressPROCESS VALIDATION PROTOCOL(CAPSULE)PROTOCOL NO: DATE OF
EFFECTIVECAPACIT1:MANUACTURER:TA5&NO&:M&O&C&CAPSULE
FILLIN5 MAC=INE:T1PE
:MODEL:CAPACIT1:MANUACTURER:TA5&NO&:M&O&C&CAPSULE
POSIS=IN5 +C=EC8IN5 MAC=INE T1PE
:MODEL:CAPACIT1:MANUACTURER:TA5&NO&:M&O&C&STRIP
PAC8IN5 MAC=INE: T1PE
:MODEL:CAPACIT1:MANUACTURER:TA5&NO&:M&O&C&*LISTER
PAC8IN5 MAC=INE:T1PE
:MODEL:CAPACIT1:MANUACTURER:TA5&NO&:Prepred 2( C"ec3ed 2(
Appro4ed 2(Company Name & AddressPROCESS VALIDATION
PROTOCOL(CAPSULE)PROTOCOL NO: DATE OF
EFFECTIVEM&O&C&CAPSULE COUNTIN5 MAC=INET1PE
:MODEL:CAPACIT1:MANUACTURER:TA5&NO&:REMAR8S:628IDENTIFICATION
OF CRITICAL PROCESS VARI.LES9 PARAMETER2Prepred 2( C"ec3ed 2(
Appro4ed 2(Company Name & AddressPROCESS VALIDATION
PROTOCOL(CAPSULE)PROTOCOL NO: DATE OF EFFECTIVE 9&/&-
PRO*A*LE CAUSES T=AT MA1 EFFECT FINAL PRODUCT:Prepred 2( C"ec3ed 2(
Appro4ed 2(MATERIALSIFTIN5MI?IN5 AIR DR1IN5 *LENDIN5 5RANULATION (
IF RE0UIRED)FILLIN5E?CIPIENTACTIVELOAD
SIBEMI?ERSPEEDMI?ERSPEEDue!ce of eHcipie!t dditio! FiHed 2tc"
%i7eLod 2'e!di!$ 4e%%e'& FiHed6 !o 4ritio! of 2'e!di!$
%peed&*'e!di!$ ti#e Vritio! of 2'e!di!$
ti#e/&FILLIN5Euip#e!t ) #et"od A!'(tic' )re%u't%&--&For
recordi!$ !'(tic' #et"od 4'idtio!&@&-DATA RECORDIN5T"e dt
o2ti!ed fro# t"e 4riou% !'(%i% + o2%er4tio!% %"'' 2e recorded i!
t"e DATA RECORDIN5 S=EET for fir%t t"ree co##erci' 2tc"e%&DATA
RECORDING SHEET A1SIFTING:E>uip#e!t N#e
:,,,,,,,,,,,,,,,,,,,,,,,,,Ide!tifictio! !o
:,,,,,,,,,,,,,,,,,,,,,,,,, Dte:,,,,,,,,,,,,,,,,,,,Sie4e%:
,,,,,,,,,,,,,,,,,,,,,,,,,I!te$rit( of t"e %ie4e (2efore):
,,,,,,,,,,,,,,,,,,, (After),,,,,,,,,,,,,,,,,,MI?ING : E>uip#e!t
!#e :,,,,,,,,,,,,,,,,,,,,,,,Prepred 2( C"ec3ed 2( Appro4ed
2(Company Name & AddressPROCESS VALIDATION
PROTOCOL(CAPSULE)PROTOCOL NO: DATE OF EFFECTIVEIde!tifictio! !o
:,,,,,,,,,,,,,,,,,,,,,,, Dte:,,,,,,,,,,,,,,,,,,,,Cpcit(:
,,,,,,,,,,,,,,,,,,,,,,'t&DRING:E>uip#e!t N#e
:,,,,,,,,,,,,,,,,,,,,,,, Dte:,,,,,,,,,,,,,,,,,,,Ide!tifictio! No
:,,,,,,,,,,,,,,,,,,,,,,,In=red#en"s and seB,en$e o- ma"er#a)
add#"#on: ,,,,,,,,,,,,,,,,,,,,Tot' wei$"t of i!$redie!t%:
,,,,,,,,,,,,,,,3$)'ot&MiHi!$ ti#e: .; #i!ute%Setti!$ I MiHer:
%'ow5r!u'tor : OFFProcedure : A% out'i!ed i! t"e 2tc" #!ufcturi!$
record&P'! : S#p'e% to 2e drw! t of .; #i!ute% of #iHi!$ fro# /
differe!t 'octio!%FOR DR MI?ING RESULTS2 .ATCH NO:Samp)e
no:148A(era=e s"d2De(2Ran=eRSDLCLUCLPOINTSMet"od of !'(%i%
doptedRef No&:A!'(%t:DteMeet ccept!ce criteri&ES !+ NO
!+CONCLUSIONS:,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,C=EC8ED
*1:,,,,,,,,,,,,,,,,,,,,,,,,, DATE,,,,,,,,,,,,,,,,,,,,Prepred 2(
C"ec3ed 2( Appro4ed 2(Company Name & AddressPROCESS VALIDATION
PROTOCOL(CAPSULE)PROTOCOL NO: DATE OF EFFECTIVEDATE RECORDING SHEET
A4*LENDIN5:E>uip#e!t !#e: OCTA5ONAL *LENDERIde!tifictio! !o:
,,,,,,,,,,,,,,,,,,,,,,,,,,,,,Dte:,,,,,,,,,,,,,,,,,,,,,,,,,Cpcit(
:,,,,,,,,,,,,,,,,,,,,,,'t&I!$redie!t% + %e>ue!ce of #teri'
dditio!:,,,,,,,,,,Procedure: % out'i!ed i! t"e 2tc" #!ufcturi!$
record&P'!: S#p'e% to 2e drw! t i!ter4'% of .; #i!ute% of
#iHi!$ fro# top 6 #idd'e6 2otto# !d poo' %#p'e&L,*r#$a"#on
res,)"s*ATC= NO: ,,,,,,,,,,,,,,,,,,,,,,Samp)e no:1486! POOL+A(era=e
s"d2De(2Ran=eRSDLCLUCLMet"od of !'(%i% doptedRef
No&:A!'(%t:DteAccept!ce criteri D: J TO -;: JMeet ccept!ce
criteri&ES !+ NO
!+CONCLUSIONS:,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,Prepred
2( C"ec3ed 2( Appro4ed 2(Company Name & AddressPROCESS
VALIDATION PROTOCOL(CAPSULE)PROTOCOL NO: DATE OF
EFFECTIVE,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,C=EC8ED
*1:,,,,,,,,,,,,,,,,,,,,,,,,,DATE,,,,,,,,,,,,,,,,,,,,Prepred 2(
C"ec3ed 2( Appro4ed 2(Company Name & AddressPROCESS VALIDATION
PROTOCOL(CAPSULE)PROTOCOL NO: DATE OF EFFECTIVEDATA RECORDING
SHEETA 8E>uip#e!t N#e: Cp%u'e fi''i!$ #c"i!eIde!tifictio! N#e:
,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,
Dte:,,,,,,,,,,,,,,,,,,,,EMectio! %ide:Left )Ri$"tS#p'e !o:
*)M)E*ATC= NO: APPEARANCE Vi%u' i!%pectio!A% %pecified i! t"e
*&M&R&
