
Record of Telephone Conversation, November 8, 2012 - HPC, Cord Blood BLA 125432


 

 
 

Submission Type: BLA    Submission ID: 125432/0    Office: OCTGT

Product:

HPC, Cord Blood

Applicant:

LifeSouth Community Blood Centers, Inc.

Telecon Date/Time: 08-Nov-2012 12:00 AM        Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s):

1. Advice

 

Author: MOHAMMED HEIDARAN

Telecon Summary:

Advice was given about the batch record

FDA Participants: None

Non-FDA Participants: None

Trans-BLA Group: No

 

Related STNs: None

Related PMCs: None

Telecon Body:

I spoke to Jill Evan VP of Quality at LifeSouth about the batch record. I emphasized the importance of including (1) all critical steps in the batch record; (2) all calculations for addition of HES or DMSO for example to the cord blood during the processing steps; and (3) Acceptance criteria for all critical process parameters such as a) time of cord blood collection to cryopreservation; b) time of DMSO addition to the processed cord blood to cryopreservation; c) predetermined time and temperature for cryopreservation (freezing acceptance criteria) etc. The sponsor agreed to send a revised batch record for further discussion.  