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Vaccines, Blood & Biologics
Submission Type: BLA Submission ID: 125416/0 Office: OBRR
Pooled Plasma, Solvent Detergent Treated (Human)
Octapharma USA, Inc.
Telecon Date/Time: 27-Mar-2012 10:00 AM Initiated by FDA? Yes
Telephone Number: ---(b)(4)------
1. Information Request
Author: JIE HE
DMPQ requested general information regarding facilities and equipments sharing for OctaplasLG with other US licensed products at OPG and OAB sites.
Randa Melhen, Ph.D. CBER/OCBQ/DMPQ
Jie He, M.S. CBER/OCBQ/DMPQ
Pratibha Rana, M.S. CBER/OBRR/DBA
Günter Iberer, Head of Production
Michael Tschannerl, Head of Production Octaplas
Thomas Eiter, Deputy Production Octaplas
Gernot Putz, Corporate Operation Support Manager
Barbara Rangetiner, Director Int. Drug Regulatory Affairs
Simone Meindl, Int. Drug. Regulatory Affairs Manager
Christina Leo, Head of Production
Katrin Karlsson, Production Support Manager
Kicki Garheden Fredriksson, Quality Assurance Manager
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
DMPQ asked Octapharma to provide a detailed side by side comparison (either flow chart or in table format) of the manufacturing process, equipment and areas of manufacture (Room, Bldg) for OctaplasLG with other US licensed products (including STN # and dates of approval) for both OPG (Vienna) and OAB (Stockholm) sites.
Octapharama was further requested to provide information on which equipment, rooms/bldgs and manufacturing processes are new for OctaplasLG and have not been previously submitted and/or approved by the Agency.
Octapharma stated that Octaplas (non-US product) and OctaplasLG share the manufacturing lines at both facilities exclusively. No other product (US or non-US licensed) is manufactured using the same production lines used for Octaplas and OctaplasLG. There is no sharing of any equipment or space between other products and OctaplasLG/Octaplas. Octapharma agreed to submit a formal response to the request by April 4, 2012.