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
Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
Telecon Date/Time: 01-SEP-2009 03:53 PM Initiated by FDA? Yes
Author: HELEN GEMIGNANI
IR for Container Closurers and Sterilizing Filters
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Gemignani, Helen S
Sent: Tuesday, September 01, 2009 3:53 PM
Cc: 'email@example.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:
- 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
- Container closure integrity testing
- 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.
- Please indicate where in the submission the validation of the sterilizing filters can be found.
Helen Sullivan Gemignani
Regulatory Project Manager
Division of Vaccines and Related Products Applications/Viral Vaccine Branch