[+] CPL CONTRACT PHARMACEUTICALS LIMITED 7600 Danbro Crescent Mississauga, Ontario LSN6L6 Phone (905) 821-7600 Fax (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 12114 1 Incident Report(s): Yes ~ No 0 Title: IR-GR-II-0053 FINAL APPROVAL This batch has been manufactured according to Good Manufacturing Practices and documents have been verified. Authorization: Title: rosn Date: FQC-024.FO
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Certificate of Manufacturing Compliance - · PDF fileCertificate of Manufacturing Compliance To: Bristol-Myers Squibb ... Quantity Released (kg): 1150.0 Manufacturing Order Revision
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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»
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
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
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.()