
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.