Recommendation to Waive Pre-Approval Inspection - Wilate, November 28, 2007

Department of Health and Human Services

Public Health Service

Food and Drug Administration

Center for Biologics Evaluation and Research

Division of Manufacturing and Product Quality

MEMORANDUM

Recommendation to Waive Pre-Approval Inspection

 

Date:                November 28, 2007

From:               Marion Michaelis, Reviewer, OCBQ/DMPQ/MRB II, HFM-676

To:                   BLA STN 125251/0; For Octapharma Pharmazeutika Produktionsges.m.b.H. (Octapharma), von Willebrand Factor                         Concentrate (Human) [Wilate] manufactured at their Vienna, Austria location.                        

Applicant:       Octapharma Pharmazeutika Produktionsges.m.b.H.

Product:          von Willebrand Factor Concentrate (Human) [Wilate]                           

Through:         Chiang Syin, Ph.D., Branch Chief, OCBQ/DMPQ/MRB II, HFM-676

Concurrent Clearance Routing

 

_________________________________________        ________

John A. Eltermann, Jr., R.Ph., M.S.        Date              CONCUR

Director, Division of Manufacturing and Product Quality, HFM-670                 

Office of Compliance and Biologics Quality                  ________

Center for Biologics Evaluation and Research             DO NOT CONCUR

 

_________________________________________        ________

Basil Golding, MD                               Date                CONCUR

Director, Division of Hematology, HFM-345               

Office of Blood Research and Review                         ________

Center for Biologics Evaluation and Research          DO NOT CONCUR 

Summary         

We recommend waiver of the pre-approval inspection, BLA for Octapharma Pharmazeutika Produktionsges m.b.H. (Octapharma) Vienna, Austria von Willebrand Factor Concentrate (Human), product name Wilate.

Brief History

The Octapharma Pharmazeutika Produktionsges.m.b.H. facility is located at 235 Oberlaaerstrasse, Vienna, Austria, employs approximately -(b)(4)- people and has been producing commercial lots of Immune Globulin Intravenous (Human) since 1995.  The Company was founded in 1983 and operates as a subsidiary of Octapharma AG, Lachen, Switzerland.  The company manufactures other biological products derived from human source plasma including Factor VIII, Factor IX, Prothrombin Complex, Albumin, and Virus Inactivated, Solvent Detergent Treated Plasma.

Description of Change:
•BLA for von Willebrand Factor Concentrate (Human) [Wilate] manufactured at Octapharma Vienna, Austria location.

Basis for the Waiver:

This waiver is based on criteria outlined in Center wide SOPP 8410 “Determining When Pre-Licensing/Pre-Approval Inspections are Necessary.”  As stated in that SOPP, it is CBER’s policy that a pre-license or pre-approval inspection will generally be necessary for an application if any of the following criteria in bold are met:
•       The facility does not hold an active US license.

Octapharma Pharmazeutika Produktionsges m.b.H. Vienna, Austria does hold U.S. license No. 1646.
•       The FDA has not inspected the facility in the last two years.

This facility (Octapharma Pharmazeutika Produktionsges m.b.H. Vienna, Austria) in the last two years was inspected by:

1. CBER (Mary P. Padgett) during the week of 22-31 March 2006 for a new isolator filling line (Filling Line -(b)(4)-) that will be used in the manufacture of Immune Globulin Intravenous (Human) [Octagam].

2. ORA/ORO/Team Biologics (Ann Marie Montemurro and Sidney B. Priesmeyer) during the week of 16-20 January 2006. The inspection was initiated as per ORA/ORO/Team Biologics FY 2006 Work-plan.
•       The previous inspection(s) revealed significant GMP violations in areas related to the processes in the submission (similar processes) or systemic problems, such as QC/QA oversight.

1. The inspection in March 2006 was classified VAI. The inspection was done by CBER for a new isolator filling line (Filling Line -(b)(4)-) that will be used in the manufacture of Immune Globulin Intravenous (Human)[Octagam].

2. The inspection in January 2006 was classified as VAI. The inspection was done by ORA/ORO/Team Biologics.  The inspection included coverage of the operations for Octagam®, Immune Globulin Intravenous (Human) 5%, a solvent/detergent treated, sterile, 5% liquid preparation of purified Immunoglobulin G (IgG) derived from large

pools of human plasma.
•       The establishment is performing significant manufacturing step(s) in new (unlicensed) areas using different equipment (representing a process change).  This would include areas that are currently dedicated areas that have not been approved as multi-product facilities/buildings/areas.

All areas used for the manufacture of von Willebrand Factor Concentrate (Human), product name Wilate, Octapharma Pharmazeutika Produktionsges m.b.H. Vienna, Austria are licensed areas.
•       The manufacturing process is sufficiently different (new production methods), specialized equipment or facilities) from that of other approved products produced by the establishment. 

The production process is similar to other plasma derived products produced at the facility.

Waiver Recommendation:

Based on the information provided in the BLA and related correspondence supporting the overall compliance status of the license holder, the review committees recommend waiving the pre-approval inspection for the facility changes associated with these supplements.

 _____________________________11/28/07_

Marion Michaelis, HFM-676                    Date

Reviewer, DMPQ
	