125742 S50 M3 32r comirnaty lot release template

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FDA-CBER-2021-5683-1149604
Page 2of 12cc: STN 125742 -0/2229/FC
LotNum ber: 
Licen seNam eofProduct: [COVID -19 mRNA Vaccine (nucleoside modified)]
Manufacturing Site :Pharmacia & Upjohn Company LLC, 7000 Portage Rd., Kalamazoo, MIC 49001 USA
Date of Manufacture: Date of Expiry:
Date of Fill:
Product Inform ation : 
COMPONENTS
Component DescriptionBatch 
NumberDate of 
Manuf.Manufacture Site QuantityTarget 
Concentration
BNT162b2 
Drug Substance
LNP Fabrication N/A
Bulk Drug Product 
Form ulationN/A
090177e197d20d57\Approved\Approved On: 16-Aug-2021 18:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149605
FDA-CBER-2021-5683-1149606
FDA-CBER-2021-5683-1149607
Page 5of 12cc: STN 125742 -0/2229/FC
LotNum ber: 
License Nam eofProduct: [COVID -19 mRNA Vaccine (nucleoside modified)]
Filled Vaccine Quality Control Tests (Continued)
Lipid Identity
Specification                 Limit              Result    __________________
Lipid Standard 
Retention 
Times (RT)Sample 
Retention Time
ALC -0315 content
ALC -0159 content
DSPC content
Cholesterol content
090177e197d20d57\Approved\Approved On: 16-Aug-2021 18:08 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149608
FDA-CBER-2021-5683-1149609
Page 7of 12cc: STN 125742 -0/2229/FC
LotNum ber: 
License Nam eofProduct: [COVID -19 mRNA Vaccine (nucleoside modified)]
Filled Vaccine Quality Control Tests (Continued)
Identity of encoded RNA sequence test
Test method                __ RT-PCR _________
Test date                                                              
Specification                Identity confirm ed              Result    __________________
  
Sample/Control Lot 
numberReplicate Ct value Acceptance 
criteriaPass/Fail
DP Sample 1
2
3
Positive PCR Control 1
2
3
Positive  
Control1
2
3
Negative PCR Control 1
2
3
Negative  
Control1
2
3
090177e197d20d57\Approved\Approved On: 16-Aug-2021 18:08 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149610
FDA-CBER-2021-5683-1149611
Page 9of 12cc: STN 125742 -0/2229/FC
LotNum ber: 
License Nam eofProduct: [COVID -19 mRNA Vaccine (nucleoside modified)]
Filled Vaccine Quality Control Tests (Continued)
Limulus A mebocyte Lysate Test
090177e197d20d57\Approved\Approved On: 16-Aug-2021 18:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149612
Page 10of 12cc: STN 125742 -0/2229/FC
LotNum ber: 
License Nam eofProduct: [COVID -19 mRNA Vaccine (nucleoside modified)]
Limulus Amebocyte Lysate (LAL) Test
090177e197d20d57\Approved\Approved On: 16-Aug-2021 18:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149613
FDA-CBER-2021-5683-1149614
Genealogy Flowchart
Page 12of 12Prepared By: Approved By: 
090177e197d20d57\Approved\Approved On: 16-Aug-2021 18:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149615