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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Rotavirus Diluent Review Memo - Rotarix

Date: March 25, 2008
To: Administrative File, STN 125265/0
From: Pete Amin, Biologist, OCBQ, DMPQ, MRB II
Jonathan Mcinnis, Biologist, OCBQ, DMPQ, MRB II
BLA Committee Member, HFM-676
Through: Laraine Henchal, OVRR, DVRPA
Subject: Rotavirus Diluent Review Memo: GlaxoSmithKline Biologicals (License # 1617); STN 125265/0 - BLA for Rotavirus Vaccine, Live, Oral, Monovalent, Rixensart, Belgium.

Action Recommended
Recommend for approval.

Summary

GlaxoSmithKline Biologicals (GSK) has developed a liquid diluent to be specifically used to reconstitute the lyophilized human rotavirus (HRV) vaccine before its oral administration. The diluent includes an antacid component to protect the vaccine during passage through the stomach and prevent its inactivation due to acidic environment.

Diluent ------------

Building ---- contains ----------- manufacturing facilities. These are used for the ------------------ reconstitution diluent for the Rotarix product. Building ------ is used for --------------------------------------------------------------------------------------------- It is also used for Diluent ------------ Both --------------------------- activities, in Bldg ------, are each performed ---------------------- rooms in the facility. This facility is approved to --------- vaccines for the US market.

Rotarix diluents preparation is a basic ------------------ operation carried out in a ------- ----------- from building ------. The diluent --------------- is carried out in class ------- (dynamic) areas. After diluent ----------------, -------------------------------------- is ----------------------------------- for filling. The tank is ----------- and kept under ------------------ until ------------ ------- for filling operations using ----.


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Questions for Additional Information Request

Regarding GSK proposal for ------------------ of Rotavirus Diluent, I requested following information on 3/21/08 (email communication).

  • Please confirm if Integrity for each container/closure system (diluent) has been validated to prevent in-process and post-process contamination over the product's intended shelf-life.
  • Please verify if, --------------------- will be included in each -----------------
  • Please verify if your procedure require - Documentation for each ------ - include an --------------------------------------------------------------------, expiration date, and storage conditions and
  • Please verify if under ---------- release, failure of more than one critical parameter will result in automatic rejection of the ---------------

-----------

GSK provided following response dated 3/25/2008 (email communication).

  • Container Closure testing is routinely conducted at -- and at the ----------.
  • Validations were performed on three consistency lots of Rotarix diluent to demonstrate the integrity of the syringes filled on -- line after the -------- sterilization step for Rotarix diluents through ---------------------- syringes were

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Review comment:

GSK response appears o adequate to address my concern and complies with FDA compliance guidance ---------------------- ---------------------------------------- --------------. I recommend approval of this diluent.

History
Date Prepared: 3/25/08 (Amin)
Date Revised: 3/28/2008
Date Commented: 3/27/2008
Date Final: 3/28/2008

 

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