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umen t Nam e. Q uality Plan for Crystal® HB s Ag Irnmunoc hromatograph1 c o ne S tep Rap, ~
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Fina lI P
Stage
J' ack·
aCK m g
Description
Process
Critical equipment

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Opcn1 tio ll

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(VIC
ttcfcfcncc

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Res ponsibility

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Sa mple l\cccplan cc A h:rt/1\cti, n l< e•c onJ
Sub-stage
--
Flow Chart
Requiring for Type S ize C riteri a Ir""' a-ece pte d
Iss ue
Operation
Manual
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so/ DP/ 521c 102 Produc1i o n
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SO I' : SW/S/002 &.
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Nm l\pplrc blc IWC K
Secondary Not App li cab le Co ll ect packin g material -25/ J I 100 .00%
fro n, ,vare ho use Exec uti ve S W /S/0 29 'v1 atcn a l Issue '>lop
packing
material And
Co ll ect Reagent RI from
Reagent J
from Fini s hed
( its respected locati on
goods
quarantine
For fin a l Kit
packin g -~ I
Print Box Manual Packing 100 .00% No t Applicable No t A pp lic bk: Bf'C.R
Printer Printing sQ/ BPl 521C I02-25/ 11
F inal Kit
Packing
Label
(:) Manual
s r c R No
Exec utive
Not A pplicable
-~-
Not App lic ble B P(_R
Labelin g ,j, La belling Pac king 100.00%
Printer 5Q/ BP/ 521C I 02. 2511 I
Exec uti ve
11 II 13PCR No
Pack Reagent Manual Packing No t Applica ble Not A pplrc hie BP< R
'1., N o t Applicab le Packing SQ!BP/ 52JCJ02-2S/ J I
100.00%
in Box and Executive
c lose box II II BPCR No -
Shrink Wrap Manual Packing 100 .00% N o t Ap plicable Not A p p lic ble 0,,..- ra;,on Log Sheet
6
Shrink Wrap Machine Shrinking Wra ppin g SQ/BP/ 521Ci02-2S/I 1
the kit Executive - <;hrinl< \\ rap
'.\.l:ich,ne. BPCR
Manual BPCR No Packing 100.00% Proper S to rage Comp ktc: 1he: f ill up BPCR
Storage F in is hed Goods Tran s fer the kit s 10
SQ/ BP/ 521Ci02-2S/I I Exec uti ve / (SO P : S W/ S/ OJ -1 ) T ra nsferrir
Q uaranline Fini shed Good s
Quaran tine Warehouse Procedure
Temp + 4 °C to +30°C Executive
Tesl Procedure S pecifica t io n \\ o rl.. Sheet.. Tesi
◊
Not A pplicable Descrip1io n o f Reage nt Manu a l Sr. Executive / Sampling Plan Reject in
No . 0 1 TP52 1C I 02-2SF Exec uti ve MD :SQ/MD/ G I 0 .23 SS52 IC I02 -2 5 F S AP ~stem Re pot
(Transactror TR521Cl02-25F
Q .-\32 ) \\ <;52ICI02 -25f
-
Spec ifi ca ti o n \\ on. Sheet. Test
◊
N o t Appli ca b le Quan lily o f Reagent No. M a nua l Test Procedure Sr. Execut ive/ Samplin g Pl an Reject in
Final kit Fin a l QC 01 T P52 1C I02-25F Excc ulive MD :SQ/MD/G 10 .23 SS 52 1C I 02-25F SA P s~, tem Repot
T e slin g Testin g (Tran"'1s:t tur TR52IC I 0 2-2 5 F
Qr\32) \\ <;521C l0 2-25F
<> Not Appli ca ble Pe rforman ce te st Manual Test Procedure Sr. Exec utive / Sampling Pla n - Speci lica tiun - -Reject in \\·,,rl- She..-t. Test
Execu1i ve MD :SQ/MD/G I 0 .23 SS 5 2 1C I 02-25F SAP ~:-".,tc:m Repot
TP52JC I 02-2SF
(Tr..1n.::...1~ti,lr TR 52I C I 0::'.- 25F
Q \ 3 2) W<; 521C I 1>2 -25~
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