Record of Telephone Conversation, June 22, 2012 - Flucelvax
Submission Type: BLA Submission ID: 125408/0 Office: OVRR
Influenza Vaccine (MDCK Cells)
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 22-Jun-2012 01:56 PM Initiated by FDA? Yes
Telephone Number: Communicated via e-mail
1. Information Request
Author: TIMOTHY FRITZ
483 Marburg requests, (b)(4) non-483 requests
FDA Participants: None
Non-FDA Participants: None
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Fritz, Timothy
Sent: Friday, June 22, 2012 1:57 PM
To: 'Gollwitzer, Matthew'
Subject: STN 125408 483 Observation comments, additional information request
Dear Mr. Gollwitzer-
CBER's review of Novartis' response to our 483 observations for the Marburg, Germany facility is ongoing. We have the following requests for additional information:
1. Regarding Observation 5A: Although it is a closed system, microbial contamination can develop over a period of time. Additionally, sterilization may not reach that amount of pooling. Please provide the bioburden results. Please clarify where the -(b)(4)- that retained water lead ---------------(b)(4)----------------------------. A drawing would be helpful.
2. Regarding Observation 5B: Please explain why your validated ---(b)(4)-- results in condensation. The system should drain the condensation. Please explain how you plan on reducing the condensation and optimizing the autoclave parameters (i.e. extending drying time/air purging, block and bleed valve). Please clarify if the collection bottles are -----------(b)(4)-----------------------------------.
3. Regarding Observation 5C: You state that you will be unable to ---(b)(4)----- step for your columns until 2013. Please explain how you will handle -----(b)(4)----- between now and implementation of (b)(4)-- in 2013.
4. Regarding Observation 6Ci: You addressed the inactivation system and splitting and ---(b)(4)-- system, however you did not address the -------(b)(4)----- unit. Please provide your response regarding the -----(b)(4)-------.
5. Regarding Observation 6Cii: Regarding the worse case locations, our concern was that the (b)(4) that was bent very tightly on the splitting and -(b)(4) system was not -(b)(4)----. Please clarify if you will be evaluating that -(b)(4)-. Additionally, you state that you will be performing the cleaning validation for the ---(b)(4)------ and -----(b)(4)----------------- that will be completed by 10/31/12. Please provide those protocols.
6. Regarding Observation 6D: You state that you will be performing cleaning verification for the unpacked columns. Please explain what you mean by "verification". How many runs will you be performing? Please provide the protocol.
If you have questions regarding the above, please contact Ellen Huang at 301-827-7199 for clarification.
Additionally, we have the following, non 483-related requests for information regarding the ---(b)(4)----- facility:
1. Please provide the filling and other product contact equipment sterilization protocol and validation summary including the thermal qualification and microbiological efficacy of the cycle.
2. Please describe your acceptance criteria for the pre-sterilized syringe and stopper used in the Optaflu filling process including a summary of vendor qualification.
We request that you provide a response to the above within 2 weeks. Please submit the requested information as an amendment to STN 125408. We recommend that you restate each item and follow it with your explanation or clarification. Use of this format helps organize the relevant information and provides a self-contained document that facilitates future reference.
If you have any questions, please contact the Regulatory Project Manager, Drs Brenda Baldwin or Timothy Fritz, at 301-796-2640 or via e-mail.
Timothy A. Fritz, Ph.D.
1451 Rockville Pike
Rockville, MD 20852
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