%PDF-1.6
%
1 0 obj
<>
endobj
5 0 obj
<>/Font<>>>/Fields[]>>
endobj
2 0 obj
<>stream
2019-04-25T08:20:40-04:00
2019-04-25T08:20:40-04:00
2019-04-25T08:20:40-04:00
Canon iR-ADV C5540
application/pdf
uuid:d21ed69b-a6fc-4693-8564-42f51aaa84cd
uuid:746f37db-8594-41b1-b4ae-cd0d0c8a1342
Adobe Acrobat Pro DC 19 Paper Capture Plug-in
endstream
endobj
3 0 obj
<>
endobj
9 0 obj
<>/ProcSet[/PDF/Text/ImageB]/XObject<>>>/Type/Page>>
endobj
10 0 obj
<>/ProcSet[/PDF/Text/ImageB]/XObject<>>>/Type/Page>>
endobj
18 0 obj
<>stream
q
611.9906616 -2.3812866 3.0798035 791.5079346 -1.5352325 1.436676 cm
/Im0 Do
Q
BT
/T1_0 1 Tf
-0.0182 Tc 3 Tr 8.6 0 0 8.6 455.01 748.2 Tm
(DCN: )Tj
0.0114 Tc 2.914 0 Td
(16-001146 )Tj
0.0107 Tc 4.706 0 Td
(v.2.0 )Tj
/T1_1 1 Tf
-0.035 Tc 9.6444 0 0 10.3 56.08 736.2 Tm
(TEST )Tj
9.6248 0 0 10.3 80.84 736.2 Tm
(METHOD )Tj
9.5143 0 0 10.3 123.32 736.2 Tm
(REFERENCE: )Tj
0.0021 Tc 10.3 0 0 10.3 180.91 736.2 Tm
(DCN: )Tj
0.009 Tc 2.813 0 Td
(16-000493 )Tj
-0.035 Tc 9.367 0 0 10.3 56.1 715.81 Tm
(INTENDED )Tj
10.0446 0 0 10.3 103.67 715.81 Tm
(USE: )Tj
0.0177 Tc 10.3 0 0 10.3 127.63 715.81 Tm
(Material )Tj
0.0215 Tc 3.845 0 Td
(Represented )Tj
-0.0118 Tc 5.505 0 Td
(by )Tj
0.0169 Tc 1.278 0 Td
(this )Tj
0.0237 Tc 1.833 0 Td
(Certificate )Tj
0.05 Tc 11.4074 0 0 10.3 304.69 715.81 Tm
(of )Tj
0.0172 Tc 10.3 0 0 10.3 316.78 715.81 Tm
(Analysis )Tj
-0.035 Tc 9.7585 0 0 10.3 357.76 715.81 Tm
(is )Tj
0.0226 Tc 10.3 0 0 10.3 367.29 715.81 Tm
(suitable )Tj
-0.0057 Tc 3.553 0 Td
(to )Tj
-0.0014 Tc 1.122 0 Td
(be )Tj
0.0109 Tc 1.281 0 Td
(used )Tj
0.0281 Tc 2.181 0 Td
(only )Tj
0.0179 Tc 2.143 0 Td
(as )Tj
0.032 Tc 1.15 0 Td
(the )Tj
0.0143 Tc (following: )Tj
0.009 Tc -41.643 -1.422 Td
(ICH )Tj
0.0349 Tc 2.048 0 Td
(Q7 )Tj
0.0319 Tc 1.583 0 Td
(Compliant )Tj
0.0299 Tc 4.754 0 Td
(cGMP )Tj
0.0253 Tc (Manufactured )Tj
0.0222 Tc 9.231 0 Td
(Excipient, )Tj
0.0132 Tc 4.609 0 Td
(for )Tj
0.01 Tc 1.502 0 Td
(use )Tj
-0.035 Tc 10.2501 0 0 10.3 317.91 701.16 Tm
(in )Tj
0.0135 Tc 10.3 0 0 10.3 328.69 701.16 Tm
(further )Tj
0.0231 Tc 3.151 0 Td
(Manufacturing. )Tj
0.0123 Tc 6.847 0 Td
(The )Tj
0.0195 Tc 1.917 0 Td
(material )Tj
0.0243 Tc 3.729 0 Td
(represented )Tj
0.0115 Tc 5.198 0 Td
(by )Tj
0.0091 Tc -47.328 -1.398 Td
(this )Tj
0.0237 Tc 1.786 0 Td
(Certificate )Tj
0.05 Tc 11.4074 0 0 10.3 123.25 686.76 Tm
(of )Tj
0.0205 Tc 10.3 0 0 10.3 135.34 686.76 Tm
(Analysis )Tj
-0.035 Tc 10.1489 0 0 10.3 176.56 686.76 Tm
(is )Tj
0.0272 Tc 10.3 0 0 10.3 185.99 686.76 Tm
(not )Tj
0.0193 Tc 1.617 0 Td
(suitable )Tj
0.0176 Tc 3.53 0 Td
(to )Tj
0.0219 Tc 1.122 0 Td
(be )Tj
0.0109 Tc 1.281 0 Td
(used )Tj
-0.0054 Tc 2.203 0 Td
(as )Tj
-0.0232 Tc 1.142 0 Td
(an )Tj
0.0187 Tc 1.267 0 Td
(Active )Tj
0.0242 Tc 3.073 0 Td
(Pharmaceutical )Tj
0.0202 Tc 6.802 0 Td
(Ingredient, )Tj
0.0351 Tc 4.895 0 Td
(Drug )Tj
0.032 Tc 2.47 0 Td
(Product )Tj
0.0495 Tc 3.56 0 Td
(or )Tj
0.0222 Tc -45.549 -1.42 Td
(Household )Tj
0.0138 Tc 4.821 0 Td
(Item. )Tj
0.0197 Tc -4.873 -1.982 Td
(OVI )Tj
-0.035 Tc 9.5322 0 0 10.3 77.59 651.72 Tm
(STATEMENT: )Tj
0.0185 Tc 10.3 0 0 10.3 137.71 651.72 Tm
(Based )Tj
0.0223 Tc 2.815 0 Td
(on )Tj
0.0086 Tc 1.335 0 Td
(the )Tj
0.0256 Tc 1.562 0 Td
(manufacturing )Tj
0.0224 Tc 6.458 0 Td
(process )Tj
0.018 Tc 3.436 0 Td
(and )Tj
0.0203 Tc 1.779 0 Td
(the )Tj
0.0234 Tc 1.554 0 Td
(controlled )Tj
0.0236 Tc 4.576 0 Td
(handling )Tj
0.018 Tc 3.975 0 Td
(and )Tj
0.0205 Tc 1.814 0 Td
(storage )Tj
0.05 Tc 11.6856 0 0 10.3 473.65 651.72 Tm
(of )Tj
0.0246 Tc 10.3 0 0 10.3 485.49 651.72 Tm
(this )Tj
0.0187 Tc 1.846 0 Td
(product, )Tj
0.02 Tc -43.578 -1.421 Td
(there )Tj
-0.035 Tc 10.1489 0 0 10.3 80.8 637.08 Tm
(is )Tj
0.0052 Tc 10.3 0 0 10.3 90.47 637.08 Tm
(no )Tj
0.0187 Tc 1.331 0 Td
(potential )Tj
0.0132 Tc 3.972 0 Td
(for )Tj
0.018 Tc 1.491 0 Td
(any )Tj
0.05 Tc 11.1292 0 0 10.3 179.17 637.08 Tm
(of )Tj
0.0086 Tc 10.3 0 0 10.3 190.77 637.08 Tm
(the )Tj
0.011 Tc 1.586 0 Td
(residual )Tj
0.0251 Tc 3.598 0 Td
(solvents )Tj
0.0038 Tc 3.804 0 Td
(listed )Tj
-0.035 Tc 10.2501 0 0 10.3 309.51 637.08 Tm
(in )Tj
0.0203 Tc 10.3 0 0 10.3 320.13 637.08 Tm
(the )Tj
0.025 Tc 1.554 0 Td
(current )Tj
0.0176 Tc 3.271 0 Td
(USP )Tj
0.026 Tc 2.236 0 Td
(method )Tj
0.028 Tc 3.446 0 Td
(<467> )Tj
0.0301 Tc 3.025 0 Td
(Tables )Tj
-0.035 Tc 9.6955 0 0 10.3 492.62 637.08 Tm
(1, )Tj
-0.0088 Tc 10.3 0 0 10.3 502.74 637.08 Tm
(2, )Tj
0.0092 Tc 1.066 0 Td
(3, )Tj
0.0495 Tc 1.05 0 Td
(or )Tj
0 Tc 1.148 0 Td
(4 )Tj
0.0176 Tc 0.793 0 Td
(to )Tj
-0.0014 Tc -47.414 -1.421 Td
(be )Tj
0.0255 Tc 1.259 0 Td
(present )Tj
0.0367 Tc 3.296 0 Td
(at )Tj
0.0203 Tc 1.033 0 Td
(the )Tj
0.0186 Tc 1.596 0 Td
(specified )Tj
0.0046 Tc 4.107 0 Td
(limits; )Tj
0.0183 Tc 2.911 0 Td
(furthermore, )Tj
0.05 Tc 11.1828 0 0 10.3 260.55 622.44 Tm
(if )Tj
0.024 Tc 10.3 0 0 10.3 269.49 622.44 Tm
(tested )Tj
0.0169 Tc 2.75 0 Td
(this )Tj
0.0208 Tc 1.822 0 Td
(product )Tj
0.0288 Tc 3.446 0 Td
(would )Tj
0.0291 Tc 2.927 0 Td
(comply )Tj
0.0153 Tc 3.457 0 Td
(with )Tj
0.0269 Tc 2.167 0 Td
(USP/NF )Tj
0.0223 Tc 3.868 0 Td
(requirements. )Tj
0.0208 Tc -41.153 -3.821 Td
(Prepared )Tj
/Suspect <>BDC
0.05 Tc 11.2028 0 0 10.3 97.45 583.08 Tm
(by:_"""r=\267\267\267~\267\\~\(~l~~----\267\267 )Tj
EMC
35.016 0 0 10.3 227.1 583.08 Tm
(----------)Tj
-0.0004 Tc 10.3 0 0 10.3 362.35 583.08 Tm
(Date: )Tj
/Suspect <>BDC
/T1_2 1 Tf
-0.0297 Tc 13.2 0 0 13.2 394.52 583.08 Tm
('{/r )Tj
EMC
/T1_1 1 Tf
0 Tc 13.8 0 0 13.8 413.37 583.08 Tm
[(f )85.2 (/ )]TJ
/Suspect <>BDC
/T1_3 1 Tf
9.3 0 0 9.3 425.4 583.08 Tm
(f )Tj
EMC
/Suspect <>BDC
/T1_4 1 Tf
10.3 0 0 10.3 431.64 583.08 Tm
(0 )Tj
EMC
/T1_1 1 Tf
-0.0004 Tc -6.727 -2.493 Td
(Date: )Tj
/Suspect <>BDC
/T1_3 1 Tf
0 Tc 12.4 0 0 12.4 393.68 557.4 Tm
(4 )Tj
EMC
/T1_4 1 Tf
0.788 0 Td
(/ )Tj
/Suspect <>BDC
13.1 0 0 13.1 409.32 557.4 Tm
(I )Tj
EMC
0.328 0 Td
($ )Tj
/Suspect <>BDC
/T1_3 1 Tf
15.3 0 0 15.3 423.1 557.4 Tm
(I )Tj
EMC
/Suspect <>BDC
/T1_4 1 Tf
15 0 0 15 429.32 557.4 Tm
(l )Tj
EMC
/Suspect <>BDC
/T1_3 1 Tf
0.243 0 Td
(q )Tj
EMC
/T1_2 1 Tf
-0.035 Tc 7.3558 0 0 7.5001 92.97 43.32 Tm
(The )Tj
/Suspect <>BDC
6.6908 0 0 7.5001 106.48 43.32 Tm
(it1/im11ario11 )Tj
EMC
0.0332 Tc 7.5001 0 0 7.5001 145.86 43.32 Tm
(con/ained )Tj
0.0178 Tc 4.419 0 Td
(herein )Tj
-0.035 Tc 7.4263 0 0 7.5001 201.51 43.32 Tm
(is )Tj
0.0011 Tc 7.5001 0 0 7.5001 208.47 43.32 Tm
(the )Tj
0.0351 Tc 1.517 0 Td
(property )Tj
0.05 Tc 9.2205 0 0 7.5001 249.52 43.32 Tm
(of )Tj
-0.0002 Tc 7.5001 0 0 7.5001 258.06 43.32 Tm
(BioSpecrra. )Tj
/Suspect <>BDC
0.012 Tc 5.271 0 Td
(7he )Tj
EMC
0.0205 Tc 1.788 0 Td
(recipient )Tj
-0.035 Tc 7.4263 0 0 7.5001 341.43 43.32 Tm
(is )Tj
0.027 Tc 7.5001 0 0 7.5001 348.44 43.32 Tm
(responsible.for )Tj
-0.015 Tc 6.713 0 Td
(its )Tj
0.0176 Tc 1.2 0 Td
(safe-keeping, )Tj
/Suspect <>BDC
0.05 Tc 7.8433 0 0 7.5001 452.11 43.32 Tm
(and )Tj
EMC
-0.0149 Tc 7.5001 0 0 7.5001 466.47 43.32 Tm
(the )Tj
0.0345 Tc 1.485 0 Td
(prevention )Tj
/Suspect <>BDC
-0.0049 Tc 4.919 0 Td
(of' )Tj
EMC
/Suspect <>BDC
-0.0189 Tc -39.963 -1.216 Td
(w1m1thori~ed )Tj
EMC
0.0177 Tc 5.821 0 Td
(appropriation, )Tj
-0.032 Tc 6.527 0 Td
(use. )Tj
0.0183 Tc 1.891 0 Td
(disclosure )Tj
/Suspect <>BDC
0.05 Tc 7.6925 0 0 7.5001 356.11 34.2 Tm
(and )Tj
EMC
7.5141 0 0 7.5001 370.26 34.2 Tm
(copying )Tj
/T1_1 1 Tf
-0.035 Tc 10.2764 0 0 10.3 283.87 23.16 Tm
(Page )Tj
0 Tc 10.3 0 0 10.3 305.46 23.16 Tm
(2 )Tj
0.05 Tc 10.5338 0 0 10.3 313.1 23.16 Tm
(of2 )Tj
ET
endstream
endobj
24 0 obj
<>/Filter/JBIG2Decode/Height 3298/Length 10092/Name/X/Subtype/Image/Type/XObject/Width 2550>>stream
8 j=6
b)P(-*LӨ(xnAh҄ 2k,&)F3暱nIe&3}9Fwf{OG:DI3y"1W5ÆA,Ƙ]/矕+SNuOu
Qq\UQ'D=i&,6-hPb''V
ܦJzgY
sL`;9&9cy $=4uj[ӃW '-&?v!9 F;$z\Rf S3
ȓ8Ct 7NlAn%0f5s8w][ebqY#
&&%OuUz
m j9A^fh_Rw-<٫.|
CWA/_i;U
*9xr2@Q8A0.I~aK18:_M<*ID`LQtq9 /w.whs4dg[vevmkwY&mca!e1 C1{J]
E-3\KjAN|W_\2~?h1YP ~@7ìR ~T6
.[v<9fS)uB>^j %=1x=) HB%ɶK(uMGc(KeM,02epv&u]ӤLrFF
'GmWVT o(iVnb0*dwUe57;⥣*'(4|j#ߍz|IthENC%'$9<A\=C+6FkJ0c1yT*"lZj8jQ>ł]hLm2Y_HƤbv6oPE>Q Xb>GȣO6; S(~tM"$ΖT."#ج4 e;#igW^]y
}HZB 2ӓR6̰Y
(Xbkb6XI#ZK}푙w՛ユ?e
#, &0.ʫZ6$شDK sΩs
I~K3~Pu4Yxm`.}Yb&幭G$MD]BO G*s S|;?٣̝6#sHc2Ke 1.)s6LY_\cenOλcI{
ˡSb|Lkχ6Ypk0-IX6q~Z?!f߰EL6qc=V|x6[Uy*ZA5[*<>rS/B$2~DWA/%[i
\}1,9!RMfBt#Cl_>ӃMTh,b&`,xF¶p2ȴR!|3)+T99