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Vaccines, Blood & Biologics

Record of Telephone Conversation, July 23, 2012 - Flucelvax


Date/Time of Call:                             July 23, 2012 @ 9 AM
CBER Representative:                    
Anissa Cheung, CSO, CBER/OVRR/DVP
Pete Amin, Reviewer, CBER/OCBQ/DMPQ/MRBII
Chiang Syin, Branch Chief, CBER/OCBQ/DMPQ/MRBII
Zhiping Ye, Research Microbiologist, CBER/OVRR/DVP/LPRVD
Xianghong Jing, Visiting Associate, CBER/OVRR/DVP/LPRVD
Brenda Baldwin, Microbiologist, CBER/OVRR/DVRPA/CMC3
Tim Fritz, CBER/OVRR/DVRPA, Microbiologist, CBER/OVRR/DVRPA/CMC2
Tim Nelle, Sr. Supervisory Regulatory, CBER/OVRR/DVRPA/CMC2
Organization Representative:         
Matthew Gollwitzer, Regulatory
Umang Shah, Regulatory
John Barry, Regulatory
Kerstin Platz, Regulatory
Manfred Brunen, Tech Transfer
Karsten Kattmann, Technical Operations
Tibor Nemes, Quality
Stefan Knapp, Quality Assurance
Martina Papadopoulos, Manufacturing
Josef Schulze, Process Manager
Peter Voelker, Quality Assurance
Michele Schmitt, Validations
Organization:                                    Novartis Vaccines and Diagnostics
Telephone:                                         -----------(b)(4)----------------------------------------------
Subject:                                              BLA STN 125408/0, Responses to 483 items in Amendment 15
STN:                                                   STN 125408/0
We contacted Novartis to discuss the firm’s responses to Amendment 15. The following information request questions were relayed to the firm.
1)      Regarding Observation 5A and US-OPF-015-1: Please clarify if ---(b)(4)--- goes into the       ------------(b)(4)------------.
2)      Regarding Observation 5B and US-OPF-015-2:
A)    Please clarify the source of the condensation observed in the collection bottle during the inspection (i.e. autoclave or ----(b)(4)-------).
B)    You stated that the autoclave parameters have been optimized as a corrective action and that it has been qualified. Please provide the qualification of autoclave.
C)    Please clarify what corrective actions have been implemented to reducing condensation in the fermentors ------(b)(4)-------.
D)    What procedural controls have you put in place to ensure you are reducing condensation?
3)      Regarding Observation 5C and US-OPF-015-2: From the lifetime studies, it appears that you have modified your cleaning and regeneration procedure for the (b)(4) column.
A)    Please specify when you have implemented the new cleaning and regeneration process for the (b)(4) column (------------(b)(4)-----------------).
B)    Please note that if this change was not reported to the Agency previously, it should have been reported as an amendment. Changes to your process need to be reported because we are basing our review on what has been submitted. Please clarify if there have been any other changes that have not been reported to the Agency.
C)    Please provide data to support these changes by demonstrating a reduction in bioburden in the cleaning evaluation sample.
D)    Please provide the SOP for the cleaning and regeneration process (including the sanitization run).
E)     Please provide the reagent(s) used in the sanitization run and the frequency of the sanitization run during normal production process.
F)     Please clarify the total volume of --(b)(4)- used for the storage of the (b)(4) column. Please also clarify if there is any change in the storage hold time of --(b)(4)-- in the column and specify the storage hold time.
G)    Please provide the re-validation data for the cleaning and regeneration of the (b)(4) column after these changes were implemented.
H)    Please specify how many batches were produced after the implementation of these changes.
I)       Please justify that all the proposed changes (---------------------------------------------------------------------------------(b)(4)------------.) in the cleaning and regeneration of the (b)(4) columns have no significant impact on the ongoing lifetime validation studies of the column.
Call Ended at 9:40 AM

Page Last Updated: 12/19/2012
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