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Vaccines

Record of Telephone Conversation - Cervarix, September 1, 2009

System Info - 104009  SHONE, DEANNA   01-Sep-2009 16:21:47  SHONEDE

RECORD OF TELEPHONE CONVERSATION

 

Submission Type: Original Application   Submission ID:  125259/0    Office: OVRR  

Product:

Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant

Applicant:                                                                       

GlaxoSmithKline Biologicals          

Telecon Date/Time:  01-SEP-2009 03:53 PM     Initiated by FDA?  Yes

Telephone Number:    

Communication Categorie(s):

Information Request

Author:  HELEN GEMIGNANI

Telecon Summary:

IR for Container Closurers and Sterilizing Filters

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No  

Related STNs:  None

Related PMCs:  None

Telecon Body:


From: Gemignani, Helen S
Sent: Tuesday, September 01, 2009 3:53 PM
To: 'Matt.Whitman@gsk.com'
Cc: 'byron.a.bravo@gsk.com'; 'Cynthia.A.D'Ambrosio@gsk.com'
Subject: Cervarix - IR for Container Closures and Sterilizing Filters

We have an Information Request for container closure and sterilizing filter info:

  1. Regarding the Container Closure systems for Cervarix – you state that the Container Closure systems proposed for Cervarix are identical to those used on other commercial vaccines manufactured by GSK.
  • Please identify these commercial products and indicate what products using the vial, syringe and stoppers used for Cervarix are licensed in the US. 
  • Please provide the descriptions for the container closure systems specific to Cervarix.  Section 3.2.P.7 appear to cover several types of syringes, stoppers and vials. 
  • Provide an overview of the testing and test results conducted specifically to the Container Closure systems to be used with Cervarix.  The tests included in Section 3.2.P.7 appear to cover several types of syringes, stoppers and vials.  Please include:
  • Extractables and Leachables
  • Sterilization
  • Container closure integrity testing
  • Lubrication
  • Please clarify the volume of the syringe used for Cervarix.  The narrative refers to a 1.25 mL syringe; however Table 3 in Section 3.2.P.7 refers to the ----b(4)------------------------ syringe. 
  1. Please indicate where in the submission the validation of the sterilizing filters can be found.

Helen Sullivan Gemignani
Regulatory Project Manager
FDA/CBER/OVRR
Division of Vaccines and Related Products Applications/Viral Vaccine Branch
(301) 827-3070