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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Record of Telephone Conversation, March 27, 2012 - Octaplas

 

Submission Type: BLA    Submission ID: 125416/0    Office: OBRR
Product:
Pooled Plasma, Solvent Detergent Treated (Human)
Applicant:
Octapharma USA, Inc.
Telecon Date/Time: 27-Mar-2012 10:00 AM        Initiated by FDA? Yes
Telephone Number: ---(b)(4)------
Communication Categorie(s):
1. Information Request
 
Author: JIE HE
Telecon Summary:
DMPQ requested general information regarding facilities and equipments sharing for OctaplasLG with other US licensed products at OPG and OAB sites.
FDA Participants:
Randa Melhen, Ph.D. CBER/OCBQ/DMPQ
Jie He, M.S. CBER/OCBQ/DMPQ
Pratibha Rana, M.S. CBER/OBRR/DBA
Non-FDA Participants:
 
Octapharma Vienna:
 
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
 
Octapharma Stockholm:
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
Telecon Body:
 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.