125742 S75 M1 attachment infographic lots

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 16 Plus Documents

2

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Recommendation –Identification of BLA Lots
Identifier Options
195 tray: Unable to apply sticker/signage 
on frozen trays. Note: Tray label contains 
QR code.
Shipping Container: Able to include a 
leaflet on top inside for identified batches.
Approach used with 25pack.
Electronic via QR codes:  Updates to HCP site 
(see next slide for details).  Allows for updates to 
lot numbers as variations are approved in BLA.  
FDA-CBER-2021-5683-0951273
Document Approval Record
Document Name: 	
  
   
	 
 
 
   
Document Title: 	
  
   
	 
 
 
   
Signed By: Date(GMT) Signing Capacity
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FDA-CBER-2021-5683-0951274