System Info - 111838 MCWATTERS, BERNARD 23-Nov-2009 09:43:38 MCWATTERS
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application Submission ID: 125297/0 Office: OVRR
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 18-AUG-2009 12:00 AM
Initiated by FDA? Yes
Author: BERNARD MCWATTERS
Requested information on CMC related issues from Rebecca Olin
FDA Participants: Bernard McWatters
Non-FDA Participants: Joanne Totosy de Zepetnek
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
I understand that you prefer to try to call, but often times it is easier for me to communicate via email. In your voicemail you requested an excel spreadsheet that was mentioned in one of the points in the previous information request email. You also requested a teleconference about the lot release protocol and the -b(4)-. I will work on all of this and contact you as soon as possible.
The reviewer for the information about the facility had a couple of additional points that need clarification:
- With regard to your --b(4)---- specification for the -b(4)-- samples taken during cleaning validation studies for the Inoculation Machine; please provide your rationale for your specification of --b(4)---. Since this --b(4)------ level is above the -b(4)-specification it could indicate that the -b(4)------- are insufficient to remove the cleaning solutions. Also include in your response any data that shows the soil level present prior to cleaning that would be used to determine the efficacy of the cleaning processes.
- Regarding the TOC acceptance criterion of --b(4)----; please provide your scientific rationale for the use of the limit of -b(4)- as an acceptable carryover limit from one production run to the next.
- Please note that your cleaning validation of the Inoculation Machine was based on conducting --b(4)-------------------------- and you state in your validation report that the -b(4)- will take place at --b(4)------------------------------------------------; however in SOP 201132-06 you mention only that the --b(4)--- cleaning of the egg -b(4)- will be conducted '--b(4)--------------- and there is no reference to the needles. Please add to the SOP specific instructions as to when the needle and egg -b(4)- are to be -b(4)---- cleaned and how it will be documented. Also include in the SOP specific cleaning and -b(4)- instructions of the needles. If you refer to another SOP for the specifics of the cleaning please include that SOP.
Thanks for your attention.
Bernard J.P. McWatters, Ph.D.
1401 Rockville Pike rm. 379N
Rockville, MD 20852
Office - 301-827-3921