Capsule Filling Machine OQ

Operational Qualification Protocol for the Capsule Filling Machine Protocol No. EQNational Institute of Health Operational Qualification Protocol Equipment:

Protocol :

!ate: 16 March, 2010

Capsule Filling Machine

Facilit": National Institute of Health

#ocation: Building 10 Room 1N249 Bethesda, MD 2092

$e%ision: !riginal

&itle: ! "erational #ualification $rotocol for the %a"sule &illing &illing Machine' O'(ecti%e: (he o)*ecti+e of this "rotocol is to document docu ment the satisfactor o"eration of the %a"sule &illing Machine used for manufacturing manufacturing at National Institute of Health )ritten *": Michael Mollo &itle: %onsultant

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Qualit" +ssurance +ppro%e, *": //////////////////////

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Qualification Process olutions Inc'

D!%MN( NMBR

P$OP$IE&+$/ INFO$M+&ION: 0nauthori1e, !uplication Is Prohi'ite, !+&E: 2345346

RI-I!N NMBR 4 3uthor. Michael Mollo //////////////////////

P+7E: 4 of 25

$e%ision !+&E: N3+

Operational Qualification #I$M #I$MN( N( N3M. N3M. %a"sule %a"sule &illi &illing ng Machine Machine

OPE$+&ION+# Q0+#IFIC+&ION FO$ &HE FO$ &HE

Capsule Filling Machine IN&+##E! +&

N+&ION+# IN&I&0&E OF HE+#&H OOM 4N89 *0I#!IN7 46 $ OOM *E&HE!+ M! 86;8

Q0+#IFIC+&ION P$OCE O#0&ION 42965 *#/&HENI+ $ ! PHOENI< M! 84424

Qualification Process olutions Inc'

D!%MN( NMBR

P$OP$IE&+$/ INFO$M+&ION: 0nauthori1e, !uplication Is Prohi'ite, !+&E: 2345346

RI-I!N NMBR 4 3uthor. Michael Mollo //////////////////////

P+7E: 4 of 25

$e%ision !+&E: N3+

Operational Qualification #I$M #I$MN( N( N3M. N3M. %a"sule %a"sule &illi &illing ng Machine Machine

OPE$+&ION+# Q0+#IFIC+&ION FO$ &HE FO$ &HE

Capsule Filling Machine IN&+##E! +&

N+&ION+# IN&I&0&E OF HE+#&H OOM 4N89 *0I#!IN7 46 $ OOM *E&HE!+ M! 86;8

Q0+#IFIC+&ION P$OCE O#0&ION 42965 *#/&HENI+ $ ! PHOENI< M! 84424

!OC.  OPE$+&ION+# Q0+#IFIC+&ION P$O&OCO# Capsule Filling Machine National Institute of Health *uil,ing 46 $oom 4n89 *ethes,a M! 86;8

Page 8 of 25

&+*#E OF CON&EN& 16 March, 2010''''''''''''' 2010'''''''''''''''''''''''''''' '''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' '''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' '''''''''''''''''''''''''''''''' '''''''''''''''''' 2 #ualit #ualit 3ssurance 3ssurance''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' '''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' '''''''''''''' 2 1'0$ur"ose 1'0$ur"ose''''''''''''' ''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' '''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' '''''''''''''''''''''''''''''' '''''''''''''''''''''''''''''''''''''''''''''''''''''''' '''''''''''''''''''''''''''''''''''''''''  2'0-co"e'' 2'0-co"e''''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' '''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' '''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''' '''''''''''' '05ui"ment Descri"tion''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''' 4'0Res"on 4'0Res"onsi)i si)iliti lities''''''''' es'''''''''''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' '''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''''''' ''''''''''''''''''' 4 '0Referen '0Reference ce Documents Documents''''''''''''''' '''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' '''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' '''''''''''''''''''''''''''''''''''''''''''''' '''''''''''''''''''''''''''''''' 4 6'0Defini 6'0Definition tions''''''''''' s''''''''''''''''''''''''' ''''''''''''''''''''''''''''' '''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' '''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''''''''''''  7'0(est &unction Num)er !ne. !ne. !# -ignature -ignature erification erification 8ist 3ttachment 3ttachment :1;'''''''''''' :1;''''''' '''''''''' '''''''''' '''''''''' ''''''''' '''''' '' '0(est &unction Num)er (s 3ttachment :7;''''''''''''''''' :7;''''''' ''''''''''''''' '''''''''' ''''''7 '7 14'0(est &unction Num)er ight. ight. -e5uence of !"erations !"erations 3ttachment :;''''''''''''''''''' :;'''''''' ''''''''''''''''''''' '''''''''''''''''' '''''''''''' '''' 7 1'0(est &unction Num)er Nine. Nine. Ma=imum ? Minimum alues 3ttachment :9;''''''''''''''''' :9;'''''''' ''''''''' ''''''''' ''''' ''''''''' ''''''7 '7 16'0De+iation Re"orting 8og 3ttachment :10;''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''' 17'0!"erational #ualification $rotocol Re+ie< 3ttachment :11;''''''''''''''''''''''''''''''''''''''''''''''''''''''''' 1'0-umm 1'0-ummar ar Re"ort Re"ort Re5uireme Re5uirements nts '''''''''''''''''''''''''''' '''''''''''''''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' '''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''''''''''''' '''''''''''''''''''''''' ''''''  19'03ttac 19'03ttachmen hmentt 8ist '''''''''''''''''''''''''''' ''''''''''''''''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' '''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''''''''''''10 ''''''''''''''''''''''''10 3ttachment :1 !# -ignature erification 8ist'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''11 3ttachment :2 (est 5ui"ment'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''12 3ttachme 3ttachment nt : $rocedure $rocedure 8ist'''''''''''''''' 8ist''''''''''''''''''''''''''''''' '''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''''''''''1 ''''''''''''''''''''''1 3ttachme 3ttachment nt :4 (raining (raining erificat erification'''''' ion''''''''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' '''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''''''''''''''''''''''' '''''''''''''''''''''''''''''''''' 14 3ttachment : !"erator %ontrols and Indicators'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''1 3ttachment :6 &unctional erification'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''19 3ttachment :6 &unctional erification'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''20 3ttachment :6 &unctional erification'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''21 3ttachment :6 &unctional erification'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''22 3ttachment :6 &unctional erification'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''2 3ttachment :7 3larms, -afeties and Interloc>s'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''2 3ttachment : -e5uence of !"eration''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''1 3ttachment : -e5uence of !"eration''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''2 3ttachment :9 Ma=imum ? Minimum alues''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''' 3ttachme 3ttachment nt :10 De+iation De+iation Re"orting Re"orting 8og''''''''''''''''''' 8og'''''''''''''''''''''''''''''''''' '''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''' ''''''''''''''''''''''''''''''''''' ''''''''''''''''''''' '''''''' 4 3ttachment :11 !"erational #ualification $rotocol Re+ie<''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''6


Page 2 of 25 4.6

Purpose

(he o)*ecti+e of this "rotocol is to +erif that the %a"sule &illing Machine, descri)ed in -ection '0, o"erates in accordance to manufacturers@ s"ecification, and in accordance
cope

(his !"erational #ualification "ertains to the +erification of the o"eration of the e5ui"ment descri)ed in -ection '0 of this "rotocol installed in the National Institute of Health, Building 10 room 1N249, Bethesda MD, 2092' (his "rotocol is s"ecific to the %a"sule &illing Machine and related instrumentation and e5ui"ment' (his "rotocol is s"ecific to the %a"sule &illing -stem, and related instrumentation and e5ui"ment, and does not address other facilit, or facilit related e5ui"ment and sstems' 2.6

Equipment !escription

(he %a"sule &illing Machine Model . anasi 6& serial CCC; is a hard gelatine ca"sule filler, motion to trans"ort ca"sules thru  "rocess stages' (he stages are. 1; 2; ; 4; ; 6; 7; ;

%a"sule feed 
(he ca"sule filling machine is com"rised of the follo

Page 9 of 25

14; %a"sule selection unit 1; 8i5uid dosing unit 16; %entral stage 17; mergenc sto" "ush )utton 1; lectric e=tension "lug

(he follo
?.6

Dimension. 2000mm F = 1670 mm H = 2140 mm 8 Feight 100 >g $o< 3ir

$esponsi'ilities

4'1

Qualification Process olutions ##C. 4'1'1 It is the res"onsi)ilit of #$- to
4'2

National Institutes of Health =I> 4'2'1 &ollo
$eference !ocuments

'1 '2 ' '4 ' '6 '7 ' '9 '10 '11 '12 '1 '14 '1 '16 '17 '1 '19 '20 '21 '22

Dra
400024E00 4400d010E7 4401d011E2 4402d012E11 440d01E1 4404d014E0 440d01E11 4407d017E01 440d01E07 4409d019E11 4410d020E11 4411d021E11 400d002E0 4002d004E07 4004d004E0 400d004E0 4009d004E11 4402d02E0 4410d090E12 400d141E06 400d142E06 400d14E06

%a"sule &illing Machine 3ssem)l Base Machine inematic Motion nit $o %a"sule %hute

Page ? of 25

'2 '24 '2 '26 '27 '2 '29 '0 '1 '2 ' '4 ' '6 '7

5.6

@.6

!efinitions

6'1

Critical Instrumentation G %ritical instruments are defined as those
6'2

NonECritical Instrumentation G Instrumentation "ro+ided for indication or con+enience "ur"oses onl'

&est Function Num'er One: OQ ignature Aerification #ist =+ttachment 4>

7'1 7'2

7'

;.6

Dra
O'(ecti%e (o identif and document all "ersonnel in+ol+ed in e=ecuting this "rotocol' Proce,ure erif that each "erson
&est Function Num'er &Bo: &est Equipment =+ttachment 8>

'1 '2

O'(ecti%e (o +erif and document all test e5ui"ment Proce,ure '2'1 %om"lete a list of all the instruments re5uired for conducting !# testing'


Page 5 of 25

'2'2

'

.6

&est Function Num'er &hree: Proce,ure #ist =+ttachment 2>

9'1

9'2

9'

46.6

O'(ecti%e (o +erif the o"erating -tandard !"erating $rocedures -!$@s; "ro+ide ade5uate direction and control o+er the o"eration of the e5ui"ment' Proce,ure 9'2'1 erif that the o"erational -!$ "ro+ides "ersonnel ade5uate direction and control o+er the o"eration of the e5ui"ment' (he -!$@s used for e=ecution ma )e in draft form'; 9'2'2 %om"lete the a""lica)le attachment
&est Function Num'er Four: &raining Aerification =+ttachment 9>

10'1

10'2

10'

44.6

erif that the test e5ui"ment?instruments are cali)rated and the reference standards are tracea)le to National Institute for -tandards and (echnolog NI-(; or other a""ro+ed standard' '2' %om"lete the a""lica)le attachment, indicating the e5ui"ment descri"tion, ID?serial num)er, cali)ration date, reEcali)ration date +cceptance Criteria 3ll e5ui"ment re5uired for e=ecution shall )e cali)rated
O'(ecti%e (o document a""lica)le "ersonnel ha+e recei+ed the re5uired training for o"eration of the e5ui"ment' Proce,ure 10'2'1 Document all "ersonnel e=ecuting this "rotocol that ha+e )een trained on the a""ro+ed?draft -!$ for the e5ui"ment' 10'2'2 8ist all -!$@s used during the e=ecution of this "rotocol 10'2' %om"lete re5uired training forms in accordance
&est Function Num'er Fi%e: Operator Controls an, In,icators =+ttachment ?>

11'1 11'2

11'

O'(ecti%e (o +erif the controls and indicators o"erate as s"ecified ) manufacturer recommendations' Proce,ure 11'2'1 Manuall o"erate the control s

Page @ of 25

48.6

&est Function Num'er i: Functional Aerification =+ttachment 5>

12'1 12'2

12'

42.6

&est Function Num'er e%en: +larms afeties an, InterlocDs =+ttachment @>

1'1 1'2

1'

49.6

O'(ecti%e (o +erif and document the o"eration and functionalit of the alarms, safeties and interloc>s' Proce,ure 1'2'1 &ollo< the "rocedures in the a""lica)le attachments' 1'2'2 isuall +erif and document the actual res"onses as "ass or fail against the e="ected results' 1'2' Document all o"erational "arameters used during e=ecution' 1'2'4 Document an discre"ancies in 3ttachment :10, De+iation Re"orting 8og' If an +ariances?de+iations are "resent, com"lete the a""ro"riate de+iation?+ariance form' +cceptance Criteria 3ll safeties and interloc> re5uirements must conform to the e="ected res"onses'

&est Function Num'er Eight: equence of Operations =+ttachment ;>

14'1 14'2

14'

4?.6

O'(ecti%e (o +erif and document the o"eration and functionalit of the e5ui"ment' Proce,ure 12'2'1 &ollo< the "rocedures in the a""lica)le attachments' 12'2'2 isuall +erif and document the actual res"onses as "ass or fail against the e="ected results' 12'2' Document all o"erational "arameters used during e=ecution' 12'2'4 Document an discre"ancies in 3ttachment :10, De+iation Re"orting 8og' If an +ariances?de+iations are "resent, com"lete the a""ro"riate de+iation?+ariance form' +cceptance Criteria 3ll functional re5uirements must conform to the e="ected res"onses'

O'(ecti%e (o +erif and document the o"erational se5uence of the sstem' Proce,ure 14'2'1 =ecute the "rocedures in the order listed' 14'2'2 !)ser+e the e="ected o"erations and e "lace' 14'2' Document an discre"ancies in 3ttachment :10, De+iation Re"orting 8og' If an +ariances?de+iations are "resent, com"lete the a""ro"riate de+iation?+ariance form' +cceptance Criteria (he o"erating se5uence occurs as e="ected'

&est Function Num'er Nine: Maimum 3 Minimum Aalues =+ttachment >

1'1 1'2

O'(ecti%e (o +erif the ma=imum and minimum allo

Page ; of 25

1'

45.6

[email protected]

!e%iation $eporting #og =+ttachment 46>

16'1

O'(ecti%e: (o document an de+iation to the stated test "rocedure or acce"tance criteria, and to e+aluate the de+iation relati+e to acce"ta)ilit of the 5ualification stud'

16'2

Proce,ure: 16'2'1 Document all de+iations found during e=ecution using the De+iation Re"ort &orm that is e co"ies of the form for each logged De+iation' 16'2'2 De+iations caused ) !ut of -"ecification !!-; %onditions' If during the e+aluation of e5ui"ment "arameters against s"ecifications, the e5ui"ment fails to meet "redetermined acce"tance criteria, a formal de+iation re"ort in+estigates the cause' In these cases, the cause must )e >noel to affect the com"letion of the "rotocol' (he "rotocol de+iation re"ort determines 1; if the acce"tance criteria are correct and current
Operational Qualification Protocol $e%ieB =+ttachment 44>

17'1

17'2

4;.6

1'2'1 Dis"la the changea)le set"oint on the a""lica)le attachment and test ma=imum and minimum +alues' 1'2'2 isuall +erif and document the actual results of the functions that a""ear on the o"erator interface' 1'2' Document an discre"ancies in 3ttachment :10, De+iation Re"orting 8og' If an +ariances?de+iations are "resent, com"lete the a""ro"riate de+iation?+ariance form' +cceptance Criteria (he actual results of the changea)le set"oint limits shall conform to the e="ected res"onses'

O'(ecti%e (o document that this "rotocol has )een re+ie
ummar" $eport $equirements

1'1

1'2

O'(ecti%e (o "ro+ide an o+er+ie< of the test results during the e=ecution of this o"erational 5ualification' Proce,ure 1'2'1 Aenerate a final summar on com"letion of this "rotocol e=ecution' 1'2'1'1 %om"ile a summar of the results o)tained'


Page  of 25

1'2'1'2

Aenerate a conclusion, )ased on these results, of the acce"ta)ilit of the 5ualification results' 1'2'1' Include a statement of conformance to the s"ecified acce"tance criteria, e+aluated in con*unction en' 1'2'1'4 Determination of acce"ta)ilit of the "rotocol, as e=ecuted' 1'2'2 3ttach the com"leted, e=ecuted and a""ro+ed "rotocol to the final re"ort' 1'2' 3ttached co"ies of all com"leted, a""ro+ed De+iation Re"ort and %orrecti+e 3ction &orms,

Page 46 of 25 4.6

+ttachment #ist

16 March, 2010'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''' 2 #ualit 3ssurance''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''' 2 1'0$ur"ose''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''  2'0-co"e'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''' '05ui"ment Descri"tion''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''' 4'0Res"onsi)ilities'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''' 4 '0Reference Documents'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''' 4 6'0Definitions'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''  7'0(est &unction Num)er !ne. !# -ignature erification 8ist 3ttachment :1;''''''''''''''''''''''''''''''''' '0(est &unction Num)er (s 3ttachment :7;''''''''''''''''''''''''''''7 14'0(est &unction Num)er ight. -e5uence of !"erations 3ttachment :;'''''''''''''''''''''''''''''''''''''''''7 1'0(est &unction Num)er Nine. Ma=imum ? Minimum alues 3ttachment :9;''''''''''''''''' '''''''''''''''7 16'0De+iation Re"orting 8og 3ttachment :10;''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''' 17'0!"erational #ualification $rotocol Re+ie< 3ttachment :11;''''''''''''''''''''''''''''''''''''''''''''''''''''''''' 1'0-ummar Re"ort Re5uirements '''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''' '''''' 19'03ttachment 8ist '''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''10 3ttachment :1 !# -ignature erification 8ist'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''11 3ttachment :2 (est 5ui"ment'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''12 3ttachment : $rocedure 8ist'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''1 3ttachment :4 (raining erification''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''' 14 3ttachment : !"erator %ontrols and Indicators'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''1 3ttachment :6 &unctional erification'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''19 3ttachment :6 &unctional erification'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''20 3ttachment :6 &unctional erification'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''21 3ttachment :6 &unctional erification'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''22 3ttachment :6 &unctional erification'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''2 3ttachment :7 3larms, -afeties and Interloc>s'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''2 3ttachment : -e5uence of !"eration''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''1 3ttachment : -e5uence of !"eration''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''2 3ttachment :9 Ma=imum ? Minimum alues''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''' 3ttachment :10 De+iation Re"orting 8og'''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''' '''''''' 4 3ttachment :11 !"erational #ualification $rotocol Re+ie<''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''6


Page 44 of 25 +ttachment 4 OQ ignature Aerification #ist

(his section identifies the "ersonnel conducting the !"erational #ualification' ach "erson
&itle

!epartment3 Compan" Name

ignature

Initials

!ate

%omments. //////////////////////////////////////////////////////////////////////// ////////////////////////////////////////////////////////////////////////////////// ////////////////////////////////////////////////////////////////////////////////// //////////////////////////////////////////////////////////////////////////////////

3cce"tance %riteria. -ignatures from all "ersonnel in+ol+ed in e=ecution of this "rotocol shall )e "resent' Meets 3cce"tance %riteria  ; es

 ; No

Re+ie
Date. //////////


Page 48 of 25 +ttachment 8 &est Equipment

(his attachment identifies the instruments, e5ui"ment, and materials that are not "art of the e5ui"ment or sstem )eing 5ualified, )ut are used in this 5ualification' Equipment !escription

Manufacturer

I!

erial 

Certifie,3 Cali'rate,

Cal. !ate

Cal !ue !ate

Initials3 !ate

es?No es?No es?No es?No es?No es?No es?No es?No es?No

%omments. ////////////////////////////////////////////////////////////////////////////// /////////////////////////////////////////////////////////////////////////////////////// /////////////////////////////////////////////////////////////////////////////////////// ///////////////////////////////////////////////////////////////////////////////////////

3cce"tance %riteria. 3ll test e5ui"ment re5uired for e=ecution shall )e cali)rated
 ; No

Re+ie
Date. //////////


Page 42 of 25 +ttachment 2 Proce,ure #ist

8ist the -tandard !"erating $rocedures -!$; that are re5uired for e=ecution of this "rotocol' OP Num'er

OP $e%ision 

Effecti%e !ate

Proce,ure &itle

!riginal

!"eration of the %a"sule &illing Machine

!riginal

Maintenance of the %a"sule &illing Machine

Initials3!ate

%omments. //////////////////////////////////////////////////////////////////////// ////////////////////////////////////////////////////////////////////////////////// ////////////////////////////////////////////////////////////////////////////////// ////////////////////////////////////////////////////////////////////////////////// 3cce"tance %riteria. 3 list of
 ; No

Re+ie
Date. //////////


Page 49 of 25 +ttachment 9 &raining Aerification

8ist the -tandard !"erating $rocedures -!$; used to train "ersonnel for o"erating the e5ui"ment'

OP 

Proce,ure &itle

!"eration of the %a"sule &illing Machine Maintenance of the %a"sule &illing Machine

&raining !ocumente, =/3N>

Initials3!ate

es?No es?No

%omments. //////////////////////////////////////////////////////////////////////// ////////////////////////////////////////////////////////////////////////////////// ////////////////////////////////////////////////////////////////////////////////// //////////////////////////////////////////////////////////////////////////////////

3cce"tance %riteria. 3 list of
Meets 3cce"tance %riteria  ; es

 ; No

Re+ie
Date. //////////


Page 4? of 25 +ttachment ? Operator Controls an, In,icators

$ress the control >es to +erif that the e5ui"ment?sstem o"erations function as indicated' Note. document an failing results' !e%ice

Epecte, $esults

+ctual $esults

Pass3Fail

%!N(R!8 $3N8 -FI(%H- and I NDI%3(!Rmergenc -to" Button' %ontrol $anel

$laces e5ui"ment in safe mode
8D 3'%' $o
Indicates 3% $o
8D &eed 8ogic %ontrol 8D Brea>ers (ri""ed 8D Hand
Indicates &eed 8ogic is ena)led' 8D Areen Indicates )rea>ers ha+e tri""ed' 8D Red Indicates manual hand
///////// e5ui"ment in safe mode ers //////// tri""ed' 8D Red Indicates manual hand
$ass?&ail

$ass?&ail

$ass?&ail

$ass?&ail

$ass?&ail

$ass?&ail

$ass?&ail

$ass?&ail

$ass?&ail $ass?&ail $ass?&ail $ass?&ail

$ass?&ail

Initials3!ate


Page 45 of 25

$o
////////// the machine normall' Red -tarts the machine //////////// the normall machine normall Indicates machine /////////// machine o"erating' 8am" o"erating' 8am" Areen Areen Indicates no ta)lets /////////// no 8D Red ta)lets 8D Red Indicates "o
$o
na)les $o
//////////// $o
$ass?&ail

8D Ma=' Oog Runtime

Indicates O!A has e=ceeded Runtime' 8D Red

Indicates O!A /////////e=ceeded Runtime' 8D Red

$ass?&ail

8D (a)let nit na)led

Indicates (a)let nit na)led' 8D Areen'

//////////// (a)let nit na)led' 8D Areen'

$ass?&ail

(a)let nit na)le -elector

na)les (a)let -elector

//////////// (a)let -elector

$ass?&ail

$roduction %ounter

Dis"las "roduction counts

//////////// "roduction counts

$ass?&ail

Hour %ounter

8ogs run time
/////////// run time
$ass?&ail

Hour %ounter

8ogs run time
/////////// run time
$ass?&ail

Hourl $roduction %ounter

8ogs run time
////////////// run time
$ass?&ail

Machine -to" $ush)utton Machine -tart $ush)utton 8am" Machine Running 8D No (a)lets 8D $o
-to"s the machine normall' Red

$ass?&ail $ass?&ail $ass?&ail $ass?&ail $ass?&ail

$ass?&ail $ass?&ail


Page 4@ of 25

Hour %ounter

8ogs run time
////////////// run time
$ass?&ail

ngage?Disengage Auards -elector

ngages ? disengages guards

///////////// ? ///////////// guards

$ass?&ail

Auards Disengaged 8D

Auards disa)led 8D Red

Auards /////////// 8D Red

$ass?&ail

R3R $3N8 -FI(%H- and INDI%3(!Rmergenc -to" Button' Machine rear "anel

$laces e5ui"ment in safe mode
Manual %ontrol Hand
ngages?Disengages Mechanical %om"onents

///////////// e5ui"ment in safe mode
$ass?&ail

$ass?&ail

-ID $3N8 -FI(%H- and INDI%3(!RReset %a"sules $roduced

Resets the ca"sule counter

/////////// the ca"sule counter

$ass?&ail

8%(RI%38 $3N8 Inside Door; -FI(%H- and INDI%3(!Racuum Bo
na)le?disa)le acuum Bo
$ellet nit 1 !N?!&&

na)le?disa)le $ellet nit 1

$ellet nit 2 !N?!&&

na)le?disa)le $ellet nit 2

/////////////? ///////////// acuum Bo
$ass?&ail

$ass?&ail

$ass?&ail

%omments. ////////////////////////////////////////////////////////////////////////


Page 4; of 25

////////////////////////////////////////////////////////////////////////////////// ////////////////////////////////////////////////////////////////////////////////// ////////////////////////////////////////////////////////////////////////////////// 3cce"tance %riteria. (he actual results are the same as the e="ected results or e="lained' Meets 3cce"tance %riteria  ; es

 ; No

Re+ie
Date. //////////


Page 4 of 25 +ttachment 5 Functional Aerification

erif that the e5ui"ment?sstem o"erations function as indicated' In"ut 3ddress I 00'00

In"ut (est Descri"tion Machine -tart $ush Button nergied-B '17; Machine -tart $ush Button Not nergied -B '17;

I 00'01

Hand
I 00'02

I 00'0

I 00'04

I 00'0

I 00'06

Oog Button energied C%'1; Oog Button deEenergied C%'1; Machine -tart Rela nergied 3'6; Machine -tart Rela DeEenergied 3'6; Auard Micro-
="ected Results

$erformed B?Date

8am" H8'6 Areen Machine starts 8am" H8'6 off Machine sto"s 8D  RD Machine
mergenc $ush Button Button energied - 43'4;

-(!$ Button RD, Machine sto""ed

mergenc $ush Button Button deEenergied - 43'4;

-(!$ Button off

(est $o
$ass? &ail

="ected Result I?! o"erates as e="ected

$ass?&ail

Initial?Date


Page 86 of 25 +ttachment 5 Functional Aerification

erif that the e5ui"ment?sstem o"erations function as indicated' In"ut 3ddress I 00'07

I 00'0

I 00'09

I 00'10

I 00'11

I 01'00

I 01'01

In"ut (est Descri"tion $oed In+erter -ignal energied 3R1'14; 8oc>ed In+erter -ignal deEenergied 3R1'14; $o
I 01'02

O!A start Rela energied 3'1; O!A start Rela deEenegied 3'1;

="ected Results

$ass? &ail

$erformed B?Date

8D 8 Red 8D 8 off 8D D flashing RD 8D D off 8D  Areen 8D  off 8D C Areen 8D C off 8D 8 Red 8D 8 off 8D D flashing RD 8D D off 8D M flashing RD, after 1 min' stead RD 8D M off Machine starts
Auards %ontrol 8D A RD e -
In"ut (est Descri"tion $rogram -to" !n -B'17D1; $rogram -to" !ff -B'17D1;

I 01'0

I 01'06

I 01'07

I 01'0

I 01'09

Machine motor )ra>e control Rela energied 3R1'14; Machine motor )ra>e control Rela deEenergied 3R1'14; Mi=er !n?!ff -
$ellet Arou" -ensor !ff -39'6; Motor !+erload I 01'10 %utout energied #M7'11; Motor !+erload %utout deEenergied #M7'11; 3ir $ressure I 01'11 -ensor energied -$9'9; 3ir $ressure -ensor deEenergied -$9'9; (est $o
="ected Results

$ass? &ail

$erformed B?Date

$rogram initiated machine sto" Machine ena)led normal Machine )ra>e engaged Machine )ra>e disE engaged 8D ( Areen 8D ( off $ellet Arou" 1 ena)led' $ellet Arou" 1 disE a)led' $ellet Arou" 2 ena)led' $ellet Arou" 2 disE a)led' 8D N Red no "ellets 8D N off 8D D Red Machine sto"s 8D D off 8D & off 8D & Red ="ected Result I?! o"erates as e="ected

$ass?&ail

Initial?Date


Page 88 of 25 +ttachment 5 Functional Aerification

erif that the e5ui"ment?sstem o"erations function as indicated' !ut"ut 3ddress

!ut"ut (est Descri"tion

="ected Results

$ass? &ail

Mi=er starts !10'00 Mi=er -tart 310'11;
Epecte, $esult

Pass3Fail

Machine -tart?-to" -e5uence 1' Fith no dosing unit installed start "um"s?as"irator' $ress machine start "ush)utton on control "anel' 2' Fhile running "ush machine sto" "ush)utton' ' Fith unit running +erif "ro"er o"eration of the emergenc sto"s "ro+ided on the machine and the control "anel' %a"sule &eed -stem

1' Machine starts and 8D R illuminates green'

1' Manuall fill ho""er
1' %a"sules flo< into the machine is initiated until sto" "ush)utton is "ressed'

2' Machine sto"s

$ass?&ail

' Machine sto"s immediatel

2' 8D M is lit'

$ass?&ail

' %losed ca"sules
$o
1' !)ser+e "o
Initials3!ate


Page 89 of 25

$ellet -stem 1' Install "ellet unit 2 in the "oe loc> and o"en the door guard and "lace selector s
1' !)ser+e "ellets filling dosators'

$ass?&ail 2' !)ser+e no "ellets 8D N is Red
%omments. /////////////////////////////////////////////////////////////////////// 3cce"tance %riteria. (he actual results are the same as the e="ected results or e="lained' Meets 3cce"tance %riteria  ; es

 ; No

Re+ie
Date. //////////


Page 8? of 25 +ttachment @ +larms afeties an, InterlocDs

erif that the alarms, safeties and interloc>s function as indicated' Proce,ure

Epecte, $esult

Pass3Fail

Initials3!ate

Epecte, $esult

Pass3Fail

Initials3!ate

Machine sto"s o"erations

$ass?&ail

CON&$O# P+NE#

Proce,ure

MRAN% -(!$

$ush an emergenc sto" )utton
8!F !8(3A &ault 8D B


Page 85 of 25

Fhen machine is "o
8o< +oltage fault 8D indicates off

$ass?&ail

D% $o
$ass?&ail

Machine in+erter fault 8D indicates flashing RD

$ass?&ail

Motor !+erlaod fault 8D indicates stead RD

$ass?&ail

D% $!FR -$$8 &38( 8D B 3ND 8D %

Fhen machine is "o
Fhile o"erating and in+erter faults 8D D is on Remo+e fuse in In+erter circuit' M!(!R !R8!3D &38( 8D D

Fhile o"erating and motor o+erloads 8D D is on Remo+e fuse in motor circuit'


Page 8@ of 25

H3NDFH88 NA3AD 383RM 8D 

Fith hand
Hand
$ass?&ail

Machine sto"s o"erations' 8D & RD

$ass?&ail

8!F $R--R 383RM 8D &

3d*ust the main regulator to cut off the air su""l
Fhile o"erating "o
$ass?&ail


Page 8; of 25

Fith no or lo< ca"sule le+el and machine running 8D
Insufficient ca"sule le+el 8D M flashing RD

$ass?&ail

Insufficient ca"sule le+el (imeout 8D M stead RD

$ass?&ail

Insufficient "ellet le+el 8D N flashing RD

$ass?&ail

Insufficient "ellet le+el (imeout 8D N stead RD

$ass?&ail

IN-&&I%IN( %3$-8 88 (IM!( 383RM 8D M

Fhen ca"sule le+el is lo< for more than one minute machine sto"s and alarm 8D changes from flashing to stead' IN-&&I%IN( $88( 88 383RM 8D N

Fith no or lo< "ellet le+el and machine running 8D
Fhen "ellet le+el is lo< for more than one minute machine sto"s and alarm 8D changes from flashing to stead'


Page 8 of 25

IN-&&I%IN( (3B8( 88 383RM 8D -

Fith no or lo< ta)let le+el and machine running 8D
Insufficient ta)let le+el 8D - flashing RD

$ass?&ail

$o
$ass?&ail

Ma=imum O!A time reached 8D  RD

$ass?&ail

$!FDR 8!3DINA M3N38 383RM 8D C

$lacing "o
!"erate *og )eond 20 sec

Page 26 of 25

A3RDDI-3B8D 383RM 8D A

Disa)le Auards eloc> s
Auards Disa)led' 8D A RD

$ass?&ail

Auards !"ened' 8D A RD

$ass?&ail

(a)let nit !n 8D 3 ARN

$ass?&ail

A3RD- !$ND 383RM 8D A

Fith machine running guards are o"ened' 8D A is on' (3B8( NI( RNNINA 383RM 8D 3

(urning on ta)let unit causes 8D 3 to )e on'

%omments. /////////////////////////////////////////////////////////////////////// 3cce"tance %riteria. (he actual results are the same as the e="ected results or e="lained' Meets 3cce"tance %riteria  ; es

 ; No

Re+ie
Date. //////////


Page 24 of 25

+ttachment ; equence of Operation

-etu" e5ui"ment to run
Proce,ure

Epecte, $esults

Pass3Fail

Initials3!ate

PoBer 0p an, "stem Operation

1

2  4  6 7  9

10 11 12

nsure that the machine is connected to a 113% "os of filled ca"sules' Restart machine and )egin "roduction'

Machine is connected to a 113% "o
$ass?&ail

$ass?&ail $ass?&ail $ass?&ail $ass?&ail $ass?&ail $ass?&ail

Machine automaticall fills ca"sules'

$ass?&ail

Machine sto"s

$ass?&ail

%a"sules are
$ass?&ail $ass?&ail

%omments. //////////////////////////////////////////////////////////////////////// 3cce"tance %riteria. (he actual results are the same as the e="ected results or e="lained' Meets 3cce"tance %riteria  ; es  ; No Re+ie
Date. //////////


Page 28 of 25

+ttachment ; equence of Operation

-etu" e5ui"ment to run
Proce,ure

Epecte, $esults

Pass3Fail

PoBer 0p an, "stem Operation - Continue, Re"eat se5uence of erif Hand
Initials3!ate

$ass?&ail

$ass?&ail

$ass?&ail $ass?&ail $ass?&ail

%omments. //////////////////////////////////////////////////////////////////////// 3cce"tance %riteria. (he actual results are the same as the e="ected results or e="lained' Meets 3cce"tance %riteria  ; es

 ; No

Re+ie
Date. //////////


Page 22 of 25 +ttachment  Maimum 3 Minimum Aalues

%hange the sstem set"oints and +erif the ma=imum and minimum +alues allo
etpoint

Machine -"eed

Minimum

Maimum

Pass3Fail

6000 ca"?hr

12000 ca"?hr

$ass?&ail

Initials3!ate

%omments. //////////////////////////////////////////////////////////////////////// ////////////////////////////////////////////////////////////////////////////////// ////////////////////////////////////////////////////////////////////////////////// //////////////////////////////////////////////////////////////////////////////////

3cce"tance %riteria. (he actual results are the same as the e="ected results or e="lained'


 ; No

Re+ie
Date. //////////


Page 29 of 25 +ttachment 46 !e%iation $eporting #og

Document all de+iations found during e=ecution' Note. Ma>e additional co"ies of this attachment as necessar' !EAI+&ION #O7 !e%iation Num'er

!escription

$esol%e, =/3N>

Initials  !ate

es ? No

es ? No

es ? No

%omments. /////////////////////////////////////////////////////////////////////// ///////////////////////////////////////////////////////////////////////////////// ///////////////////////////////////////////////////////////////////////////////// 3cce"tance %riteria. 3 list of de+iations resulting from the e=ecution of this "rotocol shall )e recorded'


 ; No

Re+ie
Date. ////////////


Page 2? of 25 Protocol !e%iation $eport =&emplate> Protocol 

Protocol ection

!ate Encountere,:

Page

Eecutor3!isco%ere, *"

tep

!escription of !e%iation

In%estigation 3 Fin,ings

tatement of Impact

$esolution

+ppro%als $ole =ecutor

Re+ie
Name =Print>

ignature

!ate

Capsule Filling Machine OQ

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