

Record of Telephone Conversation, January 19, 2012 - Flucelvax


Date/Time of Call: January 19, 2012 @ 9:30 AM

CBER Representative: 
Pete Amin, Reviewer, CBER/OCBQ/DMPQ/MRBII
Ellen Huang, CSO, CBER/OCBQ/DMPQ/MRBII

Organization Representative:
Tibor Nemes, Site Head of Quality and Managing Director, Novartis Vaccines and Diagnostics Germany
Karsten Kattmann, Segment Head, Influenza Cell Culture, Novartis Vaccines and Diagnostics Germany
Manfred Brunen, Process Expert, Influenza Cell Culture, Novartis Vaccines and Diagnostics Germany
-----------------------(b)(4)----------------------------------------------------------

Organization: Novartis Vaccines and Diagnostics

 

 

Telephone: -------------(b)(4)--------------------------

Subject: BLA STN 125408/0, communicate information

STN: STN 125408/0

We contacted Novartis to request that the firm supply the following items:

Regarding ------(b)(4)-----Facility
•Please provide FDA inspection history (date of inspection, investigator name), copy of FDA-483 and list of any regulatory actions
•Please identify the facility (building and critical process area or room, critical areas room classifications) where critical steps will be performed.
•Please provide list of critical changes made to facility, equipment, key raw materials, and qualified vendors used during process validation and identify any change made since last inspection/process validation.
•Please provide list of any changes to key critical components or vendors since process validation.
•List of multi-product/dedicated areas/equipment that will be used for this product.
•Please describe if any new or specialized equipment/areas will be used for this product (other than already licensed product/equipment for other products).

Regarding Holly Springs, NC Facility
•Please describe the all quality control functions that will be performed at this site.
•Please provide FDA inspection history (date of inspection, investigator name), copy of FDA-483 and list of any regulatory actions.
•Please provide list of critical changes made to facility, equipment, and key raw materials, and qualified vendors used during process validation and identify any change made since last process validation.
•Describe any future major manufacturing activities that you plan at this site.

Regarding ---(b)(4)---------

Novartis stated that Optaflu will be filled in building ------------------(b)(4)--------------------------------------------------------------------------------. The BLA is to fill on the pre-filled syringe line (b)(4). All product contact equipment and components are dedicated or single-use. Novartis also stated that they -----------------------(b)(4)-------------------------------------------------------------------------- is approved. Furthermore, Novartis stated that packaging will occur in building (b)(4) and the packaging line is shared.

Additionally, Novartis pointed out that their last inspection was in June 2011 and that during the inspection the Inspectors observed the filling process, visual inspection, and packaging process. There have been no changes made to the filling or packaging lines, vendors, or components since the last inspection.

Regarding Holly Springs, NC Facility

Novartis stated that the Holly Springs facility has never been inspected by the FDA and the activates occurring at that facility are SRID testing and warehousing (storage of final product). Final product release will come from Marburg, Germany.

Regarding Inspection Dates

Novartis stated that there is a Novartis Global Quality Meeting that will end on 3/15/2012. The firm stated that they can still support the inspection even if it overlaps with the Global Quality Meeting. Novartis also stated that the ---(b)(4)—facility will be undergoing an inspection by --------(b)(4)-------------------------.
