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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Interim Report on Process Validation Memo - Flublok

 

Memorandum
 
Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Manufacturing and Product Quality
                                                                                                                                                 
 
 
To:                  File STN: 125285/0/13 amendment (interim report)
 
From:             Deborah Trout, Committee Member, MRB1, DMPQ, OCBQ, HFM-675
 
 
Through:        Carolyn Renshaw, Branch Chief, MRB1, DMPQ, OCBQ, HFM-675
 
 
Subject:          Review of interim report on Process Validation of the H3 vaccine component, submitted June 15, 2009 by Protein Sciences Corporation.
 
 
Recommendation: Outstanding issues identified below can be addressed in an Information Request, Deficiencies or Incomplete Response Letter.
                                                                                                                     
Review of amendment
 
PSC has submitted a 2009 Process Validation interim report for the H3 vaccine component.
 
Comments to be conveyed to the firm:
 
1.     During ---(b)(4)--- of Lot --(b)(4)-- there was a failure of the --(b)(4)--  and it appears that approximately --------(b)(4)----------------------------------------------------------------------------------------------------. Please provide documentation that the Quality Unit reviewed and approved this ------(b)(4)---- step prior to its execution and associated deviation (#09-026) and investigation. In addition, please provide the executed batch records for ----(b)(4)----------------------of Lot -----(b)(4)-------.
 
2.     Please provide the data and associated summary report for the other strain when they become available.