Telecon, January 13, 2012 - HPC Cord Blood
RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA Submission ID: 125391/0 Office: OCTGT
Hematopoietic Progenitor Cells,Cord (HPC-C)
Telecon Date/Time: 13-January-2012 1:00 PM Initiated by FDA? Yes
Telephone Number: -----(b)(4)-----
CMC - Sterility Issues
Author: RAMANI SISTA
Deborah Havens (Supervisor, Microbiology Lab)
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Following introductions, Dr. Ghosh stated that this telecom was to further discuss the sterility validation issues, outlined in previous calls.
Regarding validation for robustness, FDA stated that since using a (b)(4) temperature may increase the minimum time of detection, the Sponsor may provide the following information in writing in lieu of conducting the test at -(b)(4)-. FDA asked the Sponsor to provide the following:
- Plan of action in the event of machine failure
- Temperature failure
FDA recommended the Sponsor to summarize their procedures in detail at -(b)(4)- and submit to application.
Regarding ruggedness, FDA recommended the Sponsor to use (b)(4) lots of media at (b)(4) in triplicate for the (b)(4) microorganisms listed in the table of the word document provided to the Sponsor earlier.