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Record of Telephone Conversation, August 28, 2012 - Flucelvax
Submission Type: BLA Submission ID: 125408/0 Office: OVRR
Influenza Vaccine (MDCK Cells)
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 28-Aug-2012 11:52 AM Initiated by FDA? Yes
1. Information Request
Author: BRENDA BALDWIN
IR for syringe container closure integrity, media fill and leachables
FDA Participants: Brenda Baldwin, Timothy Fritz
Non-FDA Participants: Matthew Gollwitzer
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Baldwin, Brenda
Sent: Tuesday, August 28, 2012 11:52 AM
To: 'Gollwitzer, Matthew'
Cc: Fritz, Timothy
Subject: 125408 Flucelvax
We have the following information request regarding the syringes:
- Please provide additional information on the syringe container closure integrity assay, specifically test sensitivity, detection limit, exposure time, size of inoculums, critical test parameters.
- We need clarification regarding the syringe media fill, specifically - CC type and size used during media fill, type and volume of media used in each containers, list of simulation used during media fill, allowable contamination rate, detail on how all of the shift covered during the media fill, incubation parameters, number vials incubated/filled/positive, number of samples used in media fill, summary of growth promotion test and results, and summary of recent media fill results.
- Please provide the test method validation for the syringe leachable study
Please try to provide this information no later than this Friday August 31, 2012. Thank you.