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OQ Raw Materials Sample Tent

OQ Raw Materials Sample Tent

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DOC No.

: __________
OPERATIONAL QUALIFICATION (OQ) PROTOCOL
Project #: OPERATIONAL QUALIFICATION OF THE RAW MATERIALS SAMPLIN TENT
EQUIPMENT (_________)
AT ANUP !A"RACHAR#A COMPAN#
ANUP
!A"RACHAR#A
FACILIT#
A$%& !'jr'c('r)'*
PROTOCOL PREPARATION
NAME AND TITLE SINATURE
DATE
(++,--,)))
PREPARED !#:
QPS* LLC
Anup Bajracharya
Consultant
THE SINATURES !ELOW INDICATE APPRO.AL OF THIS OPERATIONAL PROTOCOL. ONCE THE SINATURES ARE
O!TAINED* E/ECUTION OF THE PROTOCOL MA# !EIN.
PROTOCOL APPRO.AL
NAME AND TITLE SINATURE
DATE
(++,--,)))
DOC No.: __________
OPERATIONAL QUALIFICATION (OQ) PROTOCOL
Project #: OPERATIONAL QUALIFICATION OF THE RAW MATERIALS SAMPLIN TENT
EQUIPMENT (_________)
AT ANUP !A"RACHAR#A COMPAN#
APPRO.ED !#:
ANUP
!A"RACHAR#A
E$01$eer1$0
Facilities Manger
APPRO.ED !#:
ANUP
!A"RACHAR#A
Pro-%ct1o$ Production Manager
APPRO.ED !#:
ANUP
!A"RACHAR#A
Q%'21t) A33%r'$ce
Quality Assurance
DOC No.: __________
OPERATIONAL QUALIFICATION (OQ) PROTOCOL
Project #: OPERATIONAL QUALIFICATION OF THE RAW MATERIALS SAMPLIN TENT
EQUIPMENT (_________)
AT ANUP !A"RACHAR#A COMPAN#
ROC4.ILLE* MD
P'0e 5 o6 78
TA!LE OF CONTENTS
1.0Purpose .................................................................................................................. ............................ 3
2.0Scope ................................................................................................................................................. . 3
3.0!uip"ent #escription .................................................................................................................... ... 3
$.0%esponsi&ilities ................................................................................................................... ............... 3
'.0%e(erence #ocu"ents ................................................................................................ ........................ $
).0#e(initions .............................................................................................................. ........................... $
*.0Materials and !uip"ent ......................................................................................... .......................... $
+.0,est Function -u"&er .ne/ .Q Signature 0eri(ication 1ist 2Attach"ent 314 ................ .................. $
5.0,est Function -u"&er ,6o/ Procedure 1ist 2Attach"ent 324 .......................................... ................. '
10.0,est Function -u"&er ,hree/ ,raining 0eri(ication 2Attach"ent 334 ........................... .................. '
11.0,est Function -u"&er Four/ .perator Controls and 7ndicators 2Attach"ent 3$4 ................. ........... '
12.0,est Function -u"&er Fi8e/ Functional 0eri(ication 2Attach"ent 3)4 ..................................... ....... )
13.0#e8iation %eporting 1og 2Attach"ent 3104 .......................................................................... ........... )
1$.0.perational Quali(ication Protocol %e8ie6 2Attach"ent 3114 ........................................... .............. *
1'.0Su""ary %eport %e!uire"ents ............................................................................ .......................... *
1).0Attach"ent 1ist ......................................................................................................................... ....... *
Attach"ent 31 .Q Signature 0eri(ication 1ist ...................................................................................... .. 5
Print -a"e ................................................................................................................................................... .... 5
Attach"ent 32 Procedure 1ist ..................................................................................................... .......... 10
Attach"ent 33 ,raining 0eri(ication ......................................................................... ........................... 11
Attach"ent 3$ .perator Controls and 7ndicators ........................................................... ...................... 12
Attach"ent 3) Functional 0eri(ication ....................................................................................... .......... 13
Attach"ent 3) Functional 0eri(ication ............................................................................................... ... 1$
Attach"ent 310 #e8iation %eporting 1og .................................................................. .......................... 1'
Attach"ent 311 .perational Quali(ication Protocol %e8ie6 ................................................................. 1)
DOC No.: __________
OPERATIONAL QUALIFICATION (OQ) PROTOCOL
Project #: OPERATIONAL QUALIFICATION OF THE RAW MATERIALS SAMPLIN TENT
EQUIPMENT (_________)
AT ANUP !A"RACHAR#A COMPAN#
ROC4.ILLE* MD
P'0e 9 o6 78
7.: P%r&o3e
,he o&jecti8e o( this protocol is to 8eri(y that the %a6 Materials Sa"pling ,ent consisting o( the
co"ponents descri&ed in Section 3.09 operate in accordance to "anu(acturers: speci(ications9 and in
accordance 6ith Current ;ood Manu(acturing Practices 2c;MP:s4.
• 214 < 55=> ? 55=# ? 110=@ So(t6all clean roo" 2Model AAAAAA SerialAAAAAA4
• 224 < 23B'C+=> ? $*B'C+=# ? 13B1C2=@ MotoriDed @PA (ilter "odules 2Model AAAAAA Serial
AAAAAA4
5.: Sco&e
,his .perational Quali(ication Protocol pertains to the 8eri(ication o( the operation o( the e!uip"ent
descri&ed in Section 3.0 o( this protocol9 and installed in the A-EP BAF%AC@A%GA C.MPA-G9
%.CH07119 M#. ,his protocol is speci(ic to the %a6 Materials Sa"pling ,ent9 and related
instru"entation and e!uip"ent9 and does not address (acility9 or (acility related e!uip"ent and
syste"s.
9.: E;%1&+e$t De3cr1&t1o$
A %a6 Materials Sa"pling ,ent is pro8ided to create a conta"inantB(ree en8iron"ent o( Class 109000
(or sa"pling o( inco"ing "aterials. ,he tent is +:> ? +:1 ? +:@. ,he tent is pro8ided 6ith t6o
55.55I rated @PA (ilters to pro8ide the desired air (lo6 conditions. ,he tent is erected on an 11B
gauge tu&ular steel (ra"e 6ith 6hite &aJedBena"el (inish. 7t has 20B"il thicJ clear 8inyl 6alls that
o8erlap each other &y )= (or entry and e?it. ,6o 120B0AC recessed light (i?tures 6ith (our F$0,12
(luorescent light &ul&s are pro8ided. ,here is a 12= clearance &et6een the &otto" o( the 8inyl 6alls
and the (loor.
<.: Re3&o$31=121t1e3
$.1 Q%'2161c't1o$ Proce33 So2%t1o$3* LLC (QPS)
$.1.1 7t is the responsi&ility o( QPS to 6rite and e?ecute this .perational Quali(ication
protocol.
$.1.2 7t is the responsi&ility o( QPS to 6rite a (inal report that includes a su""ary o( 6orJ
per(or"ed9 any e?ceptions noted during the e?ecution o( the protocol9 and conclusions
deri8ed (ro" the data gathered.
$.2 ANUP !A"RACHAR#A COMPAN#
$.2.1 Follo6ing the e?ecution9 A-EP BAF%AC@A%GA:s Quality Assurance #epart"ent
6ill re8ie6 each attach"ent page to 8eri(y that the data ha8e &een co"pletely and
accurately recorded.
$.2.2 A-EP BAF%AC@A%GA:s ngineering #epart"ent is responsi&le to pro8ide all
necessary docu"entation9 including Site Acceptance ,ests9 i( applica&le9 (or the
generation9 e?ecution9 and co"pletion o( protocols9 and co"pletion o( (inal reports.
$.2.3 A-EP BAF%AC@A%GA is responsi&le (or the re8ie6 and appro8al o( this protocol
and related docu"entation to assure co"pliance 6ith A-EP BAF%AC@A%GA:s
DOC No.: __________
OPERATIONAL QUALIFICATION (OQ) PROTOCOL
Project #: OPERATIONAL QUALIFICATION OF THE RAW MATERIALS SAMPLIN TENT
EQUIPMENT (_________)
AT ANUP !A"RACHAR#A COMPAN#
ROC4.ILLE* MD
P'0e < o6 78
standard operating procedures designed to support the FAC717,G9 and to 8eri(y that
the rele8ant A-EP BAF%AC@A%GA standards (or the FAC717,G are "et.
$.2.$ A-EP BAF%AC@A%GA ngineering is responsi&le (or the re8ie6 and appro8al o(
this protocol and related docu"entation and to assure that installation and operation
are as speci(ied.
$.2.' A-EP BAF%AC@A%GA Quality Assurance is responsi&le (or the re8ie6 and appro8al
o( this protocol and the (inal su""ary report.
>.: Re6ere$ce Doc%+e$t3
'.1 A-EP BAF%AC@A%GA S.P -o./ #ocu"ent Control
'.2 A-EP BAF%AC@A%GA S.P -o./ Standard .perating Procedures
'.3 A-EP BAF%AC@A%GA S.P -o./ Standard .perating Procedure %e8ision %e!uest
'.$ A-EP BAF%AC@A%GA S.P -o./ #e8iation Control
'.' .perations Manual
'.) Purchase .rder Speci(ications
'.* #ra(t .perational S.Ps
'.+ #ra(t Cleaning S.Ps
'.5 #ra(t Maintenance S.Ps
?.: De61$1t1o$3
).1 Cr1t1c'2 I$3tr%+e$t't1o$ < Critical instru"ents are de(ined as those 6hose per(or"ance 6ill
a((ect the operation o( the syste" andCor the !uality attri&utes o( the processed "aterials.
Critical instru"ents are cali&rated and certi(ied using standards that are tracea&le to -7S,
2-ational 7nstitutes o( Standards and ,esting4.
).2 No$BCr1t1c'2 I$3tr%+e$t't1o$ < 7nstru"entation pro8ided (or indication or con8enience
purposes only.
).3 De@1't1o$ A Any e8ent 2planned or unplanned4 that has the potential to '-@er3e2) 1+&'ct
&ro-%ct ;%'21t). #e8iations "ay or "ay not ha8e the potential to i"pact operations and
operational costs.
).$ .'r1'$ce A Any e8ent 2planned or unplanned4 that has the potential to i"pact operations and
operations costs and $o 1+&'ct o$ &ro-%ct ;%'21t).
).' Correct1@e Act1o$ A A Correcti8e Action %e!uest 2CA%4 shall &e su&"itted in the e8ent o(
nonBcon(or"ity. -onBcon(or"ity is considered a (ailure in A-EP BAF%AC@A%GA:s !uality
syste".
B.: M'ter1'23 '$- E;%1&+e$t
1ist all speci(ic "aterials and e!uip"ent needed (or protocol e?ecution.
8.: Te3t F%$ct1o$ N%+=er O$e: OQ S10$'t%re .er161c't1o$ L13t (Att'c(+e$t #7)
+.1 O=ject1@e
,o identi(y and docu"ent all personnel in8ol8ed in e?ecuting this protocol.
+.2 Fre;%e$c)
,his test 6ill &e per(or"ed upon the co"pletion o( this !uali(ication protocol. ,here is no
re!uire"ent (or repeat testing unless the e!uip"ent is "odi(ied.
+.3 Proce-%re
DOC No.: __________
OPERATIONAL QUALIFICATION (OQ) PROTOCOL
Project #: OPERATIONAL QUALIFICATION OF THE RAW MATERIALS SAMPLIN TENT
EQUIPMENT (_________)
AT ANUP !A"RACHAR#A COMPAN#
ROC4.ILLE* MD
P'0e > o6 78
0eri(y that each person 6ho e?ecutes this protocol signs Attach"ent 31. ach person "ust &e
identi(ied &y na"e9 title9 co"pany9 signature9 initials and date on the attached (or".
+.$ Acce&t'$ce Cr1ter1'
Signatures (ro" all personnel in8ol8ed in e?ecution o( this protocol shall &e present.
C.: Te3t F%$ct1o$ N%+=er TDo: Proce-%re L13t (Att'c(+e$t #5)
5.1 O=ject1@e
,o 8eri(y the operating Standard .perating Procedures 2S.P:s4 pro8ide ade!uate direction and
control o8er the operation o( the e!uip"ent.
5.2 Fre;%e$c)
,his test 6ill &e per(or"ed upon the co"pletion o( this !uali(ication protocol. ,here is no
re!uire"ent (or repeat testing unless the e!uip"ent is "odi(ied.
5.3 Proce-%re
5.3.1 0eri(y that the operational S.P pro8ides personnel ade!uate direction and control o8er
the operation o( the e!uip"ent. 2,he S.P:s used (or e?ecution "ay &e in dra(t (or".4
5.3.2 Co"plete the applica&le attach"ent 6ith a list o( all applica&le S.P:s.
5.3.3 %edline the S.P:s 6ith an operator and 8alidation personnel. Attach the redline copy
to this !uali(ication protocol.
5.$ Acce&t'$ce Cr1ter1'
All associated S.P:s (or operation and e?ecution shall &e re8ie6ed and docu"ented.
7:.: Te3t F%$ct1o$ N%+=er T(ree: Tr'1$1$0 .er161c't1o$ (Att'c(+e$t #9)
10.1 O=ject1@e
,o docu"ent applica&le personnel ha8e recei8ed the re!uired training (or operation o( the
e!uip"ent.
10.2 Fre;%e$c)
,his test 6ill &e per(or"ed upon the co"pletion o( this !uali(ication protocol. ,here is no
re!uire"ent (or repeat testing unless the e!uip"ent is "odi(ied.
10.3 Proce-%re
10.3.1 #ocu"ent all personnel e?ecuting this protocol that ha8e &een trained on the
appro8edCdra(t S.P (or the e!uip"ent.
10.3.2 1ist all S.P:s used during the e?ecution o( this protocol
10.3.3 Co"plete re!uired training (or"s in A-EP BAF%AC@A%GA ,raining Progra".
10.$ Acce&t'$ce Cr1ter1'
,raining shall &e per(or"ed on all S.P:s used during the e?ecution o( this !uali(ication
protocol.
77.: Te3t F%$ct1o$ N%+=er Fo%r: O&er'tor Co$tro23 '$- I$-1c'tor3 (Att'c(+e$t #<)
11.1 O=ject1@e
,o 8eri(y the controls and indicators operate as speci(ied &y "anu(acturer reco""endations.
11.2 Fre;%e$c)
,his test 6ill &e per(or"ed upon the co"pletion o( this !uali(ication protocol. ,here is no
re!uire"ent (or repeat testing unless the e!uip"ent is "odi(ied.
11.3 Proce-%re
11.3.1 Manually operate the control s6itches listed in the applica&le attach"ent.
11.3.2 0isually 8eri(y and docu"ent the actual responses.
DOC No.: __________
OPERATIONAL QUALIFICATION (OQ) PROTOCOL
Project #: OPERATIONAL QUALIFICATION OF THE RAW MATERIALS SAMPLIN TENT
EQUIPMENT (_________)
AT ANUP !A"RACHAR#A COMPAN#
ROC4.ILLE* MD
P'0e ? o6 78
11.3.3 #ocu"ent any discrepancies in Attach"ent 3109 #e8iation %eporting 1og. 7( any
8ariancesCde8iations are present9 co"plete the appropriate de8iationC8ariance (or" as
per A-EP BAF%AC@A%GA S.P -o./ AAAAA.
11.$ Acce&t'$ce Cr1ter1'
All operator controls and indicators tested shall con(or" to the e?pected response.
75.: Te3t F%$ct1o$ N%+=er F1@e: F%$ct1o$'2 .er161c't1o$ (Att'c(+e$t #?)
12.1 O=ject1@e
,o 8eri(y and docu"ent the operation and (unctionality o( the e!uip"ent.
12.2 Fre;%e$c)
,his test 6ill &e per(or"ed upon the co"pletion o( this !uali(ication protocol. ,here is no
re!uire"ent (or repeat testing unless the e!uip"ent is "odi(ied.
12.3 Proce-%re
12.3.1 Follo6 the procedures in the applica&le attach"ents.
12.3.2 0isually 8eri(y and docu"ent the actual responses as pass or (ail against the e?pected
results.
12.3.3 #ocu"ent all para"eters used during e?ecution in Attach"ent 3*
12.3.$ #ocu"ent any discrepancies in Attach"ent 3109 #e8iation %eporting 1og. 7( any
8ariancesCde8iations are present9 co"plete the appropriate de8iationC8ariance (or" as
per A-EP BAF%AC@A%GA S.P -o./ AAAAA.
12.$ Acce&t'$ce Cr1ter1'
All (unctional re!uire"ents "ust con(or" to the e?pected responses.
79.: De@1't1o$ Re&ort1$0 Lo0 (Att'c(+e$t #7:)
13.1 O=ject1@e
,o docu"ent any de8iation to the stated test procedure or acceptance criteria9 and to e8aluate
the de8iation relati8e to accepta&ility o( the !uali(ication study.
13.2 Fre;%e$c)
All de8iations 6ill &e addressed per this section9 prior to (inal appro8al o( the !uali(ication
protocol.
13.3 Proce-%re
13.3.1 #ocu"ent all de8iations (ound during e?ecution.
13.3.2 Co"plete the #e8iationC0ariance For" as per A-EP BAF%AC@A%GA S.P -o./
AAAAA9 i""ediately upon any o&ser8ed de8iations.
13.3.3 %oute the de8iation (or" (or re8ie6 and appro8al (ro" Quality Assurance 2QA49 prior
to (inal appro8al o( this protocol.
13.3.$ 7( re!uired &y QA9 o&tain and co"plete a Correcti8e Action %e!uest 2CA%4 For" per
Correcti8e Action Syste".
13.$ Acce&t'$ce Cr1ter1'
13.$.1 All de8iations shall &e property docu"ented on the #e8iationC0ariance For".
13.$.2 All de8iation reports and correcti8e action (or"s9 i( necessary9 shall &e appro8ed prior
to (inal appro8al o( this !uali(ication protocol.
DOC No.: __________
OPERATIONAL QUALIFICATION (OQ) PROTOCOL
Project #: OPERATIONAL QUALIFICATION OF THE RAW MATERIALS SAMPLIN TENT
EQUIPMENT (_________)
AT ANUP !A"RACHAR#A COMPAN#
ROC4.ILLE* MD
P'0e B o6 78
7<.: O&er't1o$'2 Q%'2161c't1o$ Protoco2 Re@1eD (Att'c(+e$t #77)
1$.1 O=ject1@e
,o docu"ent that this protocol has &een re8ie6ed (or co"pleteness as per A-EP
BAF%AC@A%GA C.MPA-G re!uire"ents.
1$.2 Fre;%e$c)
,his test 6ill &e per(or"ed upon e?ecution co"pletion o( this operational !uali(ication
protocol. ,here is no re!uire"ent (or repeat testing unless the e!uip"ent is "odi(ied.
1$.3 Proce-%re
Co"plete attach"ent 6ith na"e9 title9 signature and date.
7>.: S%++'r) Re&ort Re;%1re+e$t3
1'.1 O=ject1@e
,o pro8ide an o8er8ie6 o( the test results during the e?ecution o( this operational
!uali(ication.
1'.2 Fre;%e$c)
,his su""ary report 6ill &e generated on the co"pletion o( the operational !uali(ication.
1'.3 Proce-%re
1'.3.1 ;enerate a (inal su""ary on co"pletion o( this protocol e?ecution.
1'.3.1.1 Co"pile a su""ary o( the results o&tained.
1'.3.1.2 ;enerate a conclusion9 &ased on these results9 o( the accepta&ility o( the
!uali(ication results.
1'.3.1.3 7nclude a state"ent o( con(or"ance to the speci(ied acceptance criteria9
e8aluated in conjunction 6ith the appro8ed de8iations and correcti8e
actions taJen.
1'.3.1.$ #eter"ination o( accepta&ility o( the protocol9 as e?ecuted.
1'.3.2 Attach the co"pleted9 e?ecuted and appro8ed protocol to the (inal report.
1'.3.3 Attached copies o( all co"pleted9 appro8ed #e8iation %eport and Correcti8e Action
For"s9 6here necessary.
7?.: Att'c(+e$t L13t
1.0Purpose .................................................................................................................. ............................ 3
2.0Scope ................................................................................................................................................. . 3
3.0!uip"ent #escription .................................................................................................................... ... 3
$.0%esponsi&ilities ................................................................................................................... ............... 3
'.0%e(erence #ocu"ents ................................................................................................ ........................ $
).0#e(initions .............................................................................................................. ........................... $
*.0Materials and !uip"ent ......................................................................................... .......................... $
+.0,est Function -u"&er .ne/ .Q Signature 0eri(ication 1ist 2Attach"ent 314 ................ .................. $
5.0,est Function -u"&er ,6o/ Procedure 1ist 2Attach"ent 324 .......................................... ................. '
10.0,est Function -u"&er ,hree/ ,raining 0eri(ication 2Attach"ent 334 ........................... .................. '
11.0,est Function -u"&er Four/ .perator Controls and 7ndicators 2Attach"ent 3$4 ................. ........... '
12.0,est Function -u"&er Fi8e/ Functional 0eri(ication 2Attach"ent 3)4 ..................................... ....... )
13.0#e8iation %eporting 1og 2Attach"ent 3104 .......................................................................... ........... )
1$.0.perational Quali(ication Protocol %e8ie6 2Attach"ent 3114 ........................................... .............. *
1'.0Su""ary %eport %e!uire"ents ............................................................................ .......................... *
1).0Attach"ent 1ist ......................................................................................................................... ....... *
DOC No.: __________
OPERATIONAL QUALIFICATION (OQ) PROTOCOL
Project #: OPERATIONAL QUALIFICATION OF THE RAW MATERIALS SAMPLIN TENT
EQUIPMENT (_________)
AT ANUP !A"RACHAR#A COMPAN#
ROC4.ILLE* MD
P'0e 8 o6 78
Attach"ent 31 .Q Signature 0eri(ication 1ist ...................................................................................... .. 5
Print -a"e ................................................................................................................................................... .... 5
Attach"ent 32 Procedure 1ist ..................................................................................................... .......... 10
Attach"ent 33 ,raining 0eri(ication ......................................................................... ........................... 11
Attach"ent 3$ .perator Controls and 7ndicators ........................................................... ...................... 12
Attach"ent 3) Functional 0eri(ication ....................................................................................... .......... 13
Attach"ent 3) Functional 0eri(ication ............................................................................................... ... 1$
Attach"ent 310 #e8iation %eporting 1og .................................................................. .......................... 1'
Attach"ent 311 .perational Quali(ication Protocol %e8ie6 ................................................................. 1)
DOC No.: __________
OPERATIONAL QUALIFICATION (OQ) PROTOCOL
Project #: OPERATIONAL QUALIFICATION OF THE RAW MATERIALS SAMPLIN TENT
EQUIPMENT (_________)
AT ANUP !A"RACHAR#A COMPAN#
ROC4.ILLE* MD
P'0e C o6 78
Att'c(+e$t #7 OQ S10$'t%re .er161c't1o$ L13t
,his section identi(ies the personnel conducting the .perational Quali(ication. ach person 6ho 6ill &e
e?ecuting this protocol shall co"plete an entry on the page.
Pr1$t N'+e T1t2e
De&'rt+e$t,
Co+&'$) N'+e
S10$'t%re I$1t1'23 D'te
Co""ents/ AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
Acceptance Criteria/ Signatures (ro" all personnel in8ol8ed in e?ecution o( this protocol shall &e
present.
Meets Acceptance CriteriaK 2 4 Ges 2 4 -o
%e8ie6ed &y/ AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA #ate/ AAAAAAAAAA
DOC No.: __________
OPERATIONAL QUALIFICATION (OQ) PROTOCOL
Project #: OPERATIONAL QUALIFICATION OF THE RAW MATERIALS SAMPLIN TENT
EQUIPMENT (_________)
AT ANUP !A"RACHAR#A COMPAN#
ROC4.ILLE* MD
P'0e 7: o6 78
Att'c(+e$t #5 Proce-%re L13t
1ist the Standard .perating Procedures 2S.P4 that are re!uired (or e?ecution o( this protocol.
SOP
N%+=er
SOP
Re@131o$ #
Proce-%re T1t2e
E66ect1@e
D'te
I$1t1'23,D'te
Cleaning o( the %a6 Materials Sa"pling ,ent
.peration o( the %a6 Materials Sa"pling ,ent
Maintenance o( the %a6 Materials Sa"pling ,ent
Co""ents/ AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
Acceptance Criteria/ A list o( 6ritten procedures that are used to operate the e!uip"ent is pro8ided a&o8e.
7( procedures are in dra(t (or"9 attach a copy to the e?ecuted protocol.
Meets Acceptance CriteriaK 2 4 Ges 2 4 -o
%e8ie6ed &y/ AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA #ate/ AAAAAAAAAA
DOC No.: __________
OPERATIONAL QUALIFICATION (OQ) PROTOCOL
Project #: OPERATIONAL QUALIFICATION OF THE RAW MATERIALS SAMPLIN TENT
EQUIPMENT (_________)
AT ANUP !A"RACHAR#A COMPAN#
ROC4.ILLE* MD
P'0e 77 o6 78
Att'c(+e$t #9 Tr'1$1$0 .er161c't1o$
1ist the Standard .perating Procedures 2S.P4 used to train personnel (or operating the e!uip"ent.
SOP # Proce-%re T1t2e
Tr'1$1$0
Doc%+e$te-
(#,N)
I$1t1'23,D'te
Cleaning o( the %a6 Materials Sa"pling ,ent GesC-o
.peration o( the %a6 Materials Sa"pling ,ent GesC-o
Maintenance o( the %a6 Materials Sa"pling ,ent GesC-o
Co""ents/ AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
Acceptance Criteria/ A list o( 6ritten procedures that are used to train personnel to operate the
e!uip"ent is pro8ided a&o8e.
Meets Acceptance CriteriaK 2 4 Ges 2 4 -o
%e8ie6ed &y/ AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA #ate/ AAAAAAAAAA
DOC No.: __________
OPERATIONAL QUALIFICATION (OQ) PROTOCOL
Project #: OPERATIONAL QUALIFICATION OF THE RAW MATERIALS SAMPLIN TENT
EQUIPMENT (_________)
AT ANUP !A"RACHAR#A COMPAN#
ROC4.ILLE* MD
P'0e 75 o6 78
Att'c(+e$t #< O&er'tor Co$tro23 '$- I$-1c'tor3
Press the control Jeys to 8eri(y that the e!uip"entCsyste" operations (unction as indicated. -ote/
docu"ent any (ailing results.
Co$tro2 F%$ct1o$
EE&ecte-
Re3%2t3
P'33,F'12 I$1t1'23,D'te
Main Po6er .-
Mo8e s6itch to .-
position
1ights co"e on
(ans start
PassCFail
Main Po6er .FF
Mo8e s6itch to .FF
position
1ights turn o(( (ans
stop
PassCFail
@PA 31 B Speed Pot
21.>4
Mo8e Pot to 1.>
Fan rotates slo6ly
or not at all
PassCFail
@PA 31 B Speed Pot
2@7;@4
Mo8e Pot to @7;@
Fan rotates at a
(aster speed
PassCFail
@PA 32 B Speed Pot
21.>4
Mo8e Pot to 1.>
Fan rotates slo6ly
or not at all
PassCFail
@PA 32 B Speed Pot
2@7;@4
Mo8e Pot to @7;@
Fan rotates at a
(aster speed
PassCFail
Co""ents/ AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
Acceptance Criteria/ ,he actual results are the sa"e as the e?pected results or e?plained.
Meets Acceptance CriteriaK 2 4 Ges 2 4 -o
%e8ie6ed &y/ AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA #ate/ AAAAAAAAAA
DOC No.: __________
OPERATIONAL QUALIFICATION (OQ) PROTOCOL
Project #: OPERATIONAL QUALIFICATION OF THE RAW MATERIALS SAMPLIN TENT
EQUIPMENT (_________)
AT ANUP !A"RACHAR#A COMPAN#
ROC4.ILLE* MD
P'0e 79 o6 78
Att'c(+e$t #? F%$ct1o$'2 .er161c't1o$
0eri(y that the e!uip"entCsyste" operations (unction as indicated.
Proce-%re EE&ecte- Re3%2t3 P'33,F'12 I$1t1'23,D'te
Face 0elocity ,est/
@PA 31 B ,urn on "ain
po6er9 turn on control &o?
po6er9 set speed to deli8er *2B
10+ (p". Measure air(lo6
using cali&rated de8ice.
!uip"ent po6ers up9 (ans
start9 @PA deli8ers *2B10+
(p".
Speed setting/ AAAAAAAAAA
Air(lo6/ AAAAAAAAAAAA
PassCFail
Face 0elocity ,est/
@PA 32 B ,urn on "ain
po6er9 turn on control &o?
po6er9 set speed to deli8er *2B
10+ (p". Measure air(lo6
using cali&rated de8ice.
!uip"ent po6ers up9 (ans
start9 @PA deli8ers *2B10+
(p".
Speed setting/ AAAAAAAAAA
Air(lo6/ AAAAAAAAAAAA
PassCFail
Static Particulate ,est/
Measure roo" particulates at
the 6orJ sur(ace using a
cali&rated "eter. Measure in
grid 6ithin tent 6orJ area
2"ini"u" + sa"ple points4.
Particulate count less than
109000 B 0.' "icron
particles.
0.' Micron A8erage Count/
AAAAAAAAAAAAAAAA
Particulate count less than
') B ' "icron particles.
' Micron A8erage Count/
AAAAAAAAAAAAAAAA
PassCFail
PressuriDation/
Measure the di((erential
pressure (ro" the inside o( the
tent to the outside using a
cali&rated "eter.
#i((erential pressure is
positi8e (ro" inside o( tent
to outside.
A8erage Pressure/ AAAAAAA
PassCFail
Co""ents/ AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
Acceptance Criteria/ ,he actual results are the sa"e as the e?pected results or e?plained.
Meets Acceptance CriteriaK 2 4 Ges 2 4 -o
%e8ie6ed &y/ AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA #ate/ AAAAAAAAAA
DOC No.: __________
OPERATIONAL QUALIFICATION (OQ) PROTOCOL
Project #: OPERATIONAL QUALIFICATION OF THE RAW MATERIALS SAMPLIN TENT
EQUIPMENT (_________)
AT ANUP !A"RACHAR#A COMPAN#
ROC4.ILLE* MD
P'0e 7< o6 78
Att'c(+e$t #? F%$ct1o$'2 .er161c't1o$
0eri(y that the e!uip"entCsyste" operations (unction as indicated.
Proce-%re EE&ecte- Re3%2t3 P'33,F'12 I$1t1'23,D'te
#yna"ic Particulate ,est/
Setup tent (or ra6 "aterial
sa"pling process. Setup
particle counter9 start counter.
Follo6ing operations S.P
si"ulate sa"pling process.
Particulate count less than
1009000 B 0.' "icron
particles.
0.' Micron A8erage Count/
AAAAAAAAAAAAAAAA
Particulate count less than
')) B ' "icron particles.
' Micron A8erage Count/
AAAAAAAAAAAAAAAA
PassCFail
%oo" Change %ate/
Calculate tent roo" change
rates. 2'12 cu.(t. roo"
8olu"eL design air(lo6 *00
c(" per (ilter4
0eri(y )0 changes per hour.
Calculated Changes/ AAAAAA
PassCFail
Co""ents/ AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
Acceptance Criteria/ ,he actual results are the sa"e as the e?pected results or e?plained.
Meets Acceptance CriteriaK 2 4 Ges 2 4 -o
%e8ie6ed &y/ AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA #ate/ AAAAAAAAAA
DOC No.: __________
OPERATIONAL QUALIFICATION (OQ) PROTOCOL
Project #: OPERATIONAL QUALIFICATION OF THE RAW MATERIALS SAMPLIN TENT
EQUIPMENT (_________)
AT ANUP !A"RACHAR#A COMPAN#
ROC4.ILLE* MD
P'0e 7> o6 78
Att'c(+e$t #7: De@1't1o$ Re&ort1$0 Lo0
#ocu"ent all de8iations (ound during e?ecution. -ote/ MaJe additional copies o( this attach"ent as
necessary.
DE.IATION LO
De@1't1o$
N%+=er
De3cr1&t1o$ Re3o2@e- (#,N) I$1t1'23 F D'te
GesC-o
GesC-o
GesC-o
GesC-o
GesC-o
GesC-o
GesC-o
GesC-o
GesC-o
GesC-o
Co""ents/ AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
Acceptance Criteria/ A list o( de8iations resulting (ro" the e?ecution o( this protocol shall &e recorded.
Meets Acceptance CriteriaK 2 4 Ges 2 4 -o
%e8ie6ed &y/ AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA #ate/ AAAAAAAAAA
DOC No.: __________
OPERATIONAL QUALIFICATION (OQ) PROTOCOL
Project #: OPERATIONAL QUALIFICATION OF THE RAW MATERIALS SAMPLIN TENT
EQUIPMENT (_________)
AT ANUP !A"RACHAR#A COMPAN#
ROC4.ILLE* MD
P'0e 7? o6 78
Att'c(+e$t #77 O&er't1o$'2 Q%'2161c't1o$ Protoco2 Re@1eD
A-EP BAF%AC@A%GA C.MPA-G:S signature &elo6 8eri(ies this .perational Quali(ication protocol has
&een re8ie6ed &y 8alidation personnel9 (or co"pleteness and (or accuracy o( calculations per A-EP
BAF%AC@A%GA C.MPA-G re!uire"ents. A separate (inal report 6ill &e 6ritten and attached to this
protocol. ,he (inal report 6ill discuss any de8iations9 conclusions9 andCor reco""endations resulting (ro" the
e?ecution o( the protocol.
-a"e 2print4/AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
,itle/ AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA
Signature/ AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA #ate/ AAAAAAAAAAAAAAAAAAAAA

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