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Vaccines

Telecon - Information Request, June 24, 2009 - Menveo

System Info - 97916  SWEET, EBONY   29-Jun-2009 15:26:50  SWEETEB

RECORD OF TELEPHONE CONVERSATION

 

Submission Type: Original Application   Submission ID:  125300/0    Office: OVRR  

Product:
Meningococcal ACWY Conjugate Vaccine

Applicant:                                                                        
Novartis Vaccines and Diagnostics, Inc.          

Telecon Date/Time:  24-JUN-2009 12:00 AM               Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Information Request

Author:  CARA FIORE

Telecon Summary:
Information Request for Menveo; See EDR for details

FDA Participants:   Cara Fiore

Non-FDA Participants:    Christopher Webster

Trans-BLA Group: No

  
Related STNs:  None

Related PMCs:  None

Telecon Body:
From: Fiore, Cara [mailto:Cara.Fiore@fda.hhs.gov]
Sent: Wednesday, June 24, 2009 11:10 AM
To: Webster, Christopher
Cc: Valenti, Elizabeth
Subject: Information Request
Hi Chris,
We have an Information request for Menveo.  Please see below:

  • In section 3.2.A.1.3.2.1 (--b(4)--- - MenA Lyophilized) reference is made to Cleaning Validation Report (CVR) 404926 for the --b(4)------------------------------- vessels and CVR 224386 for the Filling set (pumps and needles).  These validation reports were not included in the original submission or any subsequent amendment.  In addition, the validation summaries provided in this section were not detailed enough to elicit a complete review.  As such, please provide a more detailed summary of these two validation reports including but not limited to the number of studies performed, the acceptance criteria used for testing, the results, and a summary of any deviations encountered and corrective actions taken during the studies.
  • In section 3.2.A.1.2.1.2 (Rosia/Siena) you have described your approach to equipment cleaning validation in general.  Please provide the rationale for using the criterion of -b(4)----------------------------- (for dedicated equipment) of the antigen present in the equipment during the manufacturing of the following lot for product and product/detergent carry-over.  Please include details regarding how these levels of carry-over correlate to the specific analytical testing performed during the studies.

Thanks,
Cara


From: Fiore, Cara [mailto:Cara.Fiore@fda.hhs.gov]
Sent: Wednesday, June 24, 2009 11:10 AM
To: Webster, Christopher
Cc: Valenti, Elizabeth
Subject: Information Request
Hi Chris,
We have an Information request for Menveo.  Please see below:

  • In section 3.2.A.1.3.2.1 (-b(4)---- - MenA Lyophilized) reference is made to Cleaning Validation Report (CVR) 404926 for the --b(4)------------------------------------------ and CVR 224386 for the Filling set (pumps and needles).  These validation reports were not included in the original submission or any subsequent amendment.  In addition, the validation summaries provided in this section were not detailed enough to elicit a complete review.  As such, please provide a more detailed summary of these two validation reports including but not limited to the number of studies performed, the acceptance criteria used for testing, the results, and a summary of any deviations encountered and corrective actions taken during the studies.
  • In section 3.2.A.1.2.1.2 (Rosia/Siena) you have described your approach to equipment cleaning validation in general.  Please provide the rationale for using the criterion of -b(4)-----------------------------(for dedicated equipment) of the antigen present in the equipment during the manufacturing of the following lot for product and product/detergent carry-over.  Please include details regarding how these levels of carry-over correlate to the specific analytical testing performed during the studies.

Thanks,
Cara
Cara Fiore, Ph D
Division of Vaccines and Related Products Applications
Office of Vaccines Research & Review
Center for Biologics Evaluation & Research
U.S. Food & Drug Administration
WOC1 RM300N HFM-481
1401 Rockville Pike
Rockville, MD  20852