Capsule Process Validation

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&