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[+] CPLCONTRACT PHARMACEUTICALS LIMITED7600 Danbro CrescentMississauga, OntarioLSN6L6
Phone (905) 821-7600Fax (905)542-9224
Certificate of Manufacturing Compliance
To: Bristol-Myers Squibb
Product: 1 P_I_as_t_ib_as_e_5_0_W .•.•CPLProduct No.: 5003495--------------------Manufacturing Lot No. 74589--------------------
Date of Manufacture: December 20, 2011 Expiry Date:Quantity Released (kg): 1150.0 Manufacturing Order Revision No.
------------Deviation(s): Yes ~ No 0
Title: DMI-GR-ll-0161, DMI-GR-ll-0166
121141
Incident Report(s): Yes ~ No 0Title: IR-GR-II-0053
FINAL APPROVAL
This batch has been manufactured according to Good Manufacturing Practicesand documents have been verified.
Authorization:
Title: rosn Date:
FQC-024.FO
~CPL1 of 1
Laboratory ServicesCERTIFICATE OF ANALYSIS
Client: Contract Pharmaceuticals Ud. I Client 10: 2045 Revised Date: 02124/12Original Date: 02117112
Address: 7600 Danbro Crescent, Mlssissauga, Ontario l5N 616 IP#: 78969-78974
Contact Allyson Pearson I Phone: 905-821-7600 Fax: 905-821·0386Person:ProductName: PlasUbase SOW (Finished Product) Batch No.: 74589
lResults below are average of beginning. middle and Customer Lot No.: 74589end samples from validation lot 74589·Discharge#1
2 Result below Is average of beginning, middle and end Manufacturer's Lot No.: NfA
samples from valldatlon lot 74589-Dlscharge#1 and
Comments: DIscharge#2 CPL Material No.: 5003495
3 Results below are observed in each of beginning,middle and end samples from validation lot 74589-Dlscharge#1. P.O. No.: NJA
Summary Validation Report V·788PR·0·SUM
Revision#' 01
TEST I METHOD SPECIFICATION RESULT
Smooth, uniform, translucent, soft, Smooth, uniform, translucent, soli, grease·grease-like mass, free from visibleDescription 3 impurities. White in bulk, practically like mass. free from visible Impurities. While
<GM·D1> colourless In thin layers. Odourless or In bulk; practically colourless In thin layers.
slightly paraffin-like. Must not feel gritty Odourless. Old not feel gritty when rubbed
when rubbed between the Hnllers between the lingers
Polyethylene Content 1 4.50-5.50% 4.96%<249796(8» (90-110% of theory, 5%) (99% of theory)
Acidity or Alkallnitl Must be neutral 10 litmus paper Conforms<000420(S»
Bleed Test INMTO.100g
<249797(8» The weIght of oil separated must not 0.0849exceed 0.1000
Heat Stabllity 3 The sides of the cone must show no Conforms<000732(8» more than a slight curvature
SpeCific Gravity t 0.87()"0.920 0.880<249798(8»
Consistency 2Procedure B 250-320 258 (tenth of a mm)<OO95(G»
Metal Particles! NMT 3 particles/sample o particles/sample<0282(G»
Reviewed By: t.W:udl,.~ Dale: kj,h,/n- Approved By: (?I{,~.(t l\tuko.t'Date: D~\)..~I8LQua! Assurance
CPL Laboratory Services1 Valleywood Drive, Suite 100. Markham, Ontario l3R 5L9T] 905.470.2028 FJ 905.470.9241 WI www.cptnc.com
1 VaJJeywood Drive, SIite 100, Markham, Ontario.L3R 5L9 Tel. (005) 470-2028 Fax. (905) 470-9241 DfaCPL
.Laboratory Services
Certificate of Analysis Page 1 of 1
Client: Bristol Myers Squibb Client Id: 2045 Run Date: 1116/2012
Material Number: :5003495"J'i...-- ..•- ... ".
Testing POt: N1A
Specification Revision #::-1~-..... . - -\ .... -
IP #: 78969Tests Required: FULL
-...COA Revision #: .. 0 ...
Product: Plastibase 50W (Finished Product) 1249084
Batch #: 74589 Lot #: !z45S'9""1\. ... - ... J
Test Started: 01/03/2012 Test Completed: 01/10/2012
TESTIMtn"HOD SPECIFICATIONIUNIT .1 RESULTIUNIT
DescriptionGM-D1
Smooth, uniform, translucent, Smooth. uniform,soft, grease-like mass, free translucent, soft, grease-likefrom visible impurities. White in mass, free from visiblebulk; practically colourless in Impurities. White in butk~thin layers. odourless or slightly practically colourless in thinparafiin-like. Must not feel gritty layers. Odourless. Old notwhen rubbed between the feel gritty when rubbedfingers. between the fingers
Polyethylene Content249796{S)
4.50 - 5.50% (90 - 110% of 4.90% (98% of Theory)theory, 5%)
Acidity or Alkalinity000420(5)
Must be neutral to litmus paper. Conforms
Bleed Test249797(5)
NMT 0.100 g. The weight of oil 0.093gseparated must not exceed0.1OOg
Heat Stability000732(5)
The sides of the cone must Conformsshow no more than a slightcurvature
Specific Gravity249798 (5)
0.870-0.920 0.879
Consistency0095 (G)
250-320 (Approved Limits).260-300 (Caution Limits)
Average (n=3): 260
Metal Particles0282 (G)
NMT 3 particles/sample o particle/sample
Comments:Individual testing on B/M1E samples. B.eginning. (Discharged11). Validation Batch (V-788PR-Q)\._._........ .. ~
APpnOVED EY QUf-l.tliY
....~~~:rI1/d'"Ll~Auth0rjzsd SignaturGjO~
1 Valleywood Drive, S!.ite 100, MarId18111.ontarloL3R 51.9Tel. (005) 470·2028 Fax. (905) 410-9241 [.]1CPL
L.aboratory Services
Certificate of Analysis Page 1 of 1
Client: Bristol Myers Squibb Client Id: 2045 Run Date: 1116/2012
Material Number: 5003495
Testing POI: NlA
Specification Revision #: 1 -. _.. - -....------ ..-
IP#: 78970Tests Required: FULLCOA Revision #:.. --0 --
Product: Plastibase SOW (Finished Product) 1249084Batch #: 74589 Lot#: 74589
Test Started: 01/03/2012 Test Completed: 01/10/2012
TESTIMETHOD SPECIFICATIONIUNIT!i RESULTIUNIT
DescriptionGM-D1
Smooth, uniform, translucent, Smooth, uniform,soft, grease-like mass, free translucent, soft, grease-likefrom visible impurities. White in mass, free from visiblebulk; practically colourless in impurities. White in bulk;thin layers. odourless or slightly practically colourJessin thinparafiin-like. Must not feel gritty layers. Odourless. Did notwhen rubbed between the feel gritty when rubbedfingers. between the fingers
PolyethyleneContent249796(S)
4.50 ~5.50% {90 ~110% of 4.98% (100% of Theory)theory, 5%)
Acidity or Alkalinity000420(8)
Must be neutral to litmus paper. Conforms
Bleed Test249797(8)
NMT 0.100 9. The weight of oil 0.097gseparated must not exceedO.1OOg
Heat Stability000732(S)
The sides of the cone must Conformsshow no more than a slight-curvature
Specific Gravity249798(S)
0.870-0.920 0.881
Consistency0095 (G)
250-320 (Approved Limits).260-300 (Caution limits)
Average (n=3): 258
Metal Particles0282 (G)
NMT 3 particles/sample 1 particle/sample
Comments:Individual testing on BJMIE samples. ~Iddle: (D.iScharg(;d·1");validatlon Batch (V-788PR-o)
"'-' ....
APPi10VED ev C.UAUTY
.J3'..~~l\r~Authorized S!gnaiure/Date
1 VaIleywood Drive, Suite 100, Markflem. onterloL3R 5L9 Tel. (OOS)470-2028 Fax. (905) ·470-9241 C.l CPL
Laboratory Services
Certificate of Analysis Page 1 of 1
Client: Bristol Myers Squibb Client Id: 2045 Run Date: 1/16/2012
Material Number: 5003495
Testing POI: N/A
Spec.ificatlon Revision #: 1
IPi:Tests Required:
COA Revision #: .
78971FULLo
Product: Plastibase 50W (Finished Product) 1249084
Batch l#: 74589 l.ot #: 74589
Test Started: 01/0312012 Test Completed: 01/10/2012
TESTIMETHOD SPECIFICATIONIUNIT I RESULTIUNrr
DescriptionGM-D1
Smooth, uniform, translucent, Smooth, uniform,soft, grease-like mass, free translucent, soft, grease-likefrom visible impurities. White In mass, free from visiblebulk; practically colourless in impurities. White in bulk;thin layers. odourless or slightly practically colourless in thinparafiin-like. Must not feel gritty layers. Odourless. Did notwhen rubbed between the feel gritty when rubbedfingers. between the fingers
PolyethyleneContent249796(S)
4.50 - 5.50% (90 • 110% of 4.99% (100% of Theory)theory, 5%)
Acidity or Alkalinity000420(5)
Must be neutral to litmus paper. Conforms
Bleed Test249797(5)
NMT 0.100 g, The weight of oil 0.061gseparated must not exceed0.100g
Heat Stability000732(5)
The sides of the cone must Conformsshow no more than a slightcurvature
Specific Gravity249798 (S)
0.870-0.920 0.880
Consistency0095 (G)
250-320 (Approved Limits), Average (n=3): 259260-300 (Caution Limits)
Metal Particles0282 (G)
NMT 3 particles/sample 0 particle/sample
Comments:Individual testing on BIM/E samples.End. "(OlSChargE(i-1) Validation Batch (V-788PR.()
'.•""" .••. .... .•. .. J
F.PPR~VEf) e~FQ!J(.\UTY
_~_4..J'.k.· :»tIe-I! 1:p.utr,orizGd Signature/Date
t Valeywood Drive, Stite 100, Markham, OrtarloL3R SL9 Tel. (905) 470-2028 Fax. (905) 470-9241 [.•] CPL
Laboratory Services
Certificate of Analysis Page 1 of 1
Client: Bristol Myers Squibb Client Id: 2045 Run Date: 1/16/2012
Material Number: ~O:Q~95'j
Testing POI: N/A
. Specification Revision #: <:J"} .
IP #:Tests Required:
. ·..COA.Revislon.#:
78972REDUCED0 ...
Product: Plastibase 50W (Finished Product) 1249084Batch #: 74589
Test Started: 01/1212012 Test Completed: 01/1212012
TEST/METHOD SPECIFICATIONIUNITI
i RESULTIUNITI
Consistency0095 (G)
250~320 (Approved Limits),260~300 (Caution Limits)
Average (n = 3): 257
Comments:Individual testing on BIMIEsamples.Beginnin~V(OlsChilrgea~} Validation Batch (V-788PR'()}
\__ - . .'" ." . --'.
APpnovcr" E'! QUALITY_~~-s;,go 1.-Autnorlzed Signature Oat,
;:
1 Ve!leywood Drive, SUIte.1.oo; ~ion_at'lo'l3R 51..9Tel. (905) 470-2028 f~;-(905):47t:i-9241 alaCPL
Laboratory Services
Certificate of Analysis Page 1 of 1
Client: Bristol Myers Squibb Client Id: 2045 Run Date: 1/1612012
Material Number: 5003495TestingPOI: N/A
Specification Revision #: 1- ---
IP #: 78973
Tests Required: REDUCEDCOA Revision #:- -. 0
Product: Plastibase SOW (Finished Product) 1249084Batch#: 74589 Lot#: 74589TestStarted: 01/1212012 TestCompleted: 01/1212012
TESTIMETHOD SPECIFICATIONIUNIT I RESULTIUNIT
Consistency0095 (G)
250-320 (Approved Limits).260-300 (Caution Limits)
Average (n = 3): 259
Comments:Indivldual testing on ~ samples.Me. jDischarged2).Yalidatlon Batch (V-788PR-o)
1 Valleywood Drive, Slite 100, Markhan, Ontariol3R 5L9 Tel. (905) 470-2028 Fax. (905) 470-9241 ["':1CPL
L.aboratcry Services
Certificate of Analysis Page 1 of 1
Client: Bristol Myers Squibb Client Id: 2045 Run Date: 1/16/2012
Material Number: 5003495Testing PO#: NlA
Specification Revision #: 1
IP#: 78974Tests Required: REDUCEDCOA Revision.#: .0
Product: Plastibase 50W (Finished Product) 1249084Batch I: 74589 Lot#: 74589
Test Started: 01/1212012 Test Completed: 01/1212012
TEST/METHOD SPEC/FICA TlONlUNIT I RESULTIUNIT,Consistency0095 (G)
250-320 (ApprOVed Umits),260-300 (Caution Limits)
Average (n=3): 258
Comments:Individual testing on BIMIE samples}End.-(DI~~I1~rgiK!-=-?):Validation Batch (V-788PR·O)
\.--~-., ..
AP?i10VF..D l~':' QUf.\U1Y
--iJL~Jd I~/"-Authorlzed Signature/oiite