
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.