
Record of Telephone Conversation, November 29, 2012pm - Q-Pan
 

 

Submission Type: BLA

Submission ID: 125419/0

Office: OVRR

Product:
 Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

Applicant:
 ID Biomedical Corporation of Quebec dba GlaxoSmithKline Biologicals

Telecon Date/Time: 29-Nov-2012 12:00 PM Initiated by FDA? Yes

Telephone Number: 610-787-3435

Communication Categorie(s):
 1. Information Request

Author: CARMEN M. COLLAZO-CUSTODIO

Telecon Summary:
 Clarification on environmental monitoring qualifications studies performed at the Rixensart facility

FDA Participants: Carmen M. Collazo-Custodio, Randa Melhem

Non-FDA Participants: Michael Schwartz

Telecon Body:
 CBER contacted the applicant to request clarification on reports that contain several discrepancies. The reports were:

RX20070040, Environment qualification of the -(b)(4)-, rooms ----------------------------------------------------------------------(b)(4)--------------------------------------------------------------------- 
 The protocol was approved in February 12, 2007. GSK reported that the validation was performed from February 12, through April 24, 2007, and the report was approved in December 13, 2007. CBER inquired about the following:
1. The (b)(4) validation runs were performed on February 12, 20 and 22. Please explain why the validation runs were not conducted on ----(b)(4)------------. 
2.The report shows that the study was performed in February; please explain why the report states that the study was performed from February 12, through April 24, 2007.
3.If the study was performed in February (to April), 2007, please justify why the report was approved in December 2007. 

RX20070673, Intensive environmental monitoring Building---(b)(4)--- - Filling Unit - ----(b)(4)-- - Room ---(b)(4)---- 

CBER inquired about the following:


4.The dates in the report indicate the study was done in August 2007, and approved on October 25, 2007. However, GSK provided data generated in 2008. Please explain this discrepancy.
5.We noted that the ---(b)(4)----------- were conducted in August 2008. Please explain the reason for taking one year to run the (b)(4). 
6.Please clarify whether there is a final report that includes the data generated in 2008. 

RX20070513, Environment qualification of the room ---(b)(4)------ Building (b)(4)- Filling Facility
 CBER inquired about the following: 

7.The report was approved in February 2009. All the data were collected in 2007; therefore, it is not clear why the report provided the date of October 31, 2008, or approval in February 2009. Please clarify.

Dr. Schwartz agreed to inquire about the discrepancies in these reports and provide feedback to CBER.
