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Vaccines, Blood & Biologics

Record of Telephone Conversation, October 26, 2012 pm - Flucelvax


Submission Type: BLA    Submission ID: 125408/0    Office: OVRR
Influenza Virus Vaccine
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 26-Oct-2012 12:10 PM        Initiated by FDA? Yes
Telephone Number:
Communication Categorie(s):
1. Other -
Telecon Summary:
Request for commitment to non-PMC and non-PMR issues.
FDA Participants: Brenda Baldwin
Non-FDA Participants: Matthew Gollwitzer
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
E-mail Body:
DATE:            October 26, 2012
TO:                 Matthew Gollwitzer
                        Senior Regulatory Affairs Specialist
FROM:                Brenda Baldwin, Ph.D.
SUBJECT:     Commitment to provide requested information
PRODUCT:   Influenza Virus Vaccine, Flucelvax
SPONSOR:    Novartis Vaccines and Diagnostics, Inc.
STN:               125408
The following have been identified as items that will need to be provided by Novartis. Please provide a written commitment stating your intentions to implement and provide results as noted for each item.
  1. The current assay for detection of BPL may not be appropriate for the validation of the BPL -----------(b)(4)-------- for the improved process 1.1. Please commit to explore other quantitative assays for BPL before proceeding to perform the BPL -----------(b)(4)--------- study. Please provide a timeline for submission of this information. Please commit to provide the BPL content of ------(b)(4)------------ for the 2012/2013 influenza season.
  2. “Absence of extraneous virus” testing for the ---(b)(4)---- is currently performed at -----------(b)(4)--------------- step, as opposed to -----(b)(4)------. While CBER accepts the supportive data provided in amendment 34, please commit to re-evaluating the limit of detection of adventitious agents at the ----(b)(4)------ step.
  3. Please commit to employ ----------------------------------------(b)(4)----------------------------------------------------------------------------------------------------------------------------------------------. In the situation where the (b)(4) type is not identical to the vaccine strain (b)(4), please commit to determine the origination of the (b)(4) type to rule out the derivation of -------- (b)(4).
  4. Please commit to develop and implement an alternate method for detection of non-cultivable Mycoplasma in viral harvests. We suggest that you implement this test before the 2012/2013 influenza season. Please provide a timeline for this implementation.
  5. Please commit to provide data to support shipping of samples from Marburg to Holly Springs. These studies should be completed before the 2012/2013 influenza season. Please provide a timeline for the data submission.
  6. Studies are being performed for the validation of -(b)(4)-- for the ----(b)(4)------------- with manufacturing process 1.1, and the completion of this validation is expected by December 2014 (483 - Observation 4). Please commit to submit the validation report to CBER by December 2014. 
  7. Please commit to provide the hold time study report for the trivalent bulk stored in the             ---------(b)(4)--------------------- (483 - Observation 3) and the final assessment report on the hold time studies of both the ------(b)(4)------------------ manufacturing processes at the Marburg location which will need to include the time zero value as the product quality indicating parameter (483 –Observation 6).  Please provide a timeline for submission of this information.
  8. Cleaning validation was not performed on the -----------------------(b)(4)--------------------------------------------------------------------. Current cleaning procedures of these units only include a ----------------------(b)(4)--------------------------------- (483 - Observation 6D). Please commit to complete cleaning verification for the ---(b)(4)--- by December 2013 and for the ----(b)(4)------ by December 2014.
  9. During the inspection, ---(b)(4)--- samples were not taken on the -----------------------------------------(b)(4)---------------------------------------------------------. Additionally, a (b)(4) swab sample at the worst-case-location was not sampled in the ----(b)(4)---------------------------- (483 - Observation 6C). Please commit to provide the cleaning validation for the  ---------(b)(4)---------------------------- by November 2012.
  10. Please commit to update the media simulation run plan document #268236 (483 - Observation 7). 
  11. During the inspection, there was no procedural requirement to remove residual water after cleaning the unpacked columns and packing unit (483 - Observation 5C). Please commit to revise SOP 239705---------(b)(4)---- and SOP 222168 -----(b)(4)------------ by 2013. These revisions should include a ----(b)(4)------ for the removal of residual water and modifications to the equipment to be able to dry the equipment.

Page Last Updated: 12/19/2012
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