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Vaccines, Blood & Biologics

3/28/2008 Email - Rotarix

From: QuanderIII, Joseph

Sent: Friday, March 28, 2008 6:40 PM

To: ''

Cc: ''; Henchal, Laraine; Vujcic, Luba

Subject: RE: Rotarix

Ms. Boyce,

There is one issue with the protocol and it concerns the Sterility and Mycoplasma testing. The table format for the data is there, but then it appears the same information will repeated using the other format generated by your company's reporting system. I only need to see the table formats for Sterility and Mycoplasma; the other version that repeats the Sterility and Mycoplasma data can be excluded.

There are several items that I notice that either need to be changed or I need clarification.

On Page one the term "Lot No." should be used not "Lot No. of final vaccine".

On the other pages there are other types of Lot Numbers. What Component lot number? Also what do the terms batch number and ANNEX are used on several pages refer to? Do these the lot number terms of the product or of a bulk component?

I would like the have the lot number just below the "Licensed Name of the Product". The "cc:", the "Licensed Name of the Product", and "Lot No." needs to appear as the first three lines of the protocol for every page.

If your system allows please remove the CERTIFICATE OF ANALYSIS, it is not needed to refer to the lot release protocol.

I also noticed that there are two sets of page numbers; one at the top of the page for the overall document count and another page count in multiple sections. What is the second page count?

Thank you,

Joseph A. L. Quander III
Chief, Product Release Branch
Division of Manufacturing and Product Quality
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research

(301) 594-6517; (301) 594-6924(Fax)


From: []

Sent: Friday, March 21, 2008 12:31 PM

To: QuanderIII, Joseph

Cc: Dougherty, Suanne;

Subject: Fw: Rotarix

Dear Dr. Quander,

Attached below is the revised version of the Rotarix (STN 125265) Lot Release Protocol Template, incorporating your recent comments. A copy of this template has also been submitted as an amendment to the pending BLA.

Please contact me with any questions.

Best Regards,

Donna Boyce
Sr. Director
USRA Pediatric Vaccines

----- Forwarded by Donna 2 Boyce/PharmRD/GSK on 03/21/2008 12:20 PM -----

Donna 2 Boyce/PharmRD

18-Mar-2008 15:21
US Regulatory Affairs, Pediatric Vaccines RN0210 610-787-3767

"Henchal, Laraine" <>




The revised Lot Release Protocol is attached. A copy is also being sent to J. Quander and will be submitted officially as amendment by Friday.

Best regards,

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

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