Vaccines, Blood & Biologics
Team Meeting 5, January 7, 2013 - HPC, Cord Blood BLA 125432
DATE: January 7, 2013
- None at this time
- Sterility Test: The proposed volume of the test sample ((b)(4) of the final product) was inadequate. The sponsor is revalidating their sterility assay by using --------(b)(4)----------------------------------) and will submit the data in near future. Joy has gone through the sterility protocol with the sponsor and the protocol is acceptable..
- Outstanding Major issues:
- LifeSouth needs to complete the growth promotion validation (483 #4) and the environmental qualification validation (483 #8) for the clean room. Marion and Chad went through several rounds of protocol review with the firm and they are ready to start the studies. They did not indicate when this would be completed (FDA can inquire about dates at the next meeting with the firm). Related to these studies they also needed to purchase a new incubator and perform IQ/OQ/PQ on this piece of equipment.
- Outstanding minor issues: Clarification needed for the 483 Responses submitted 12/12/12
- Clarifications needed for item #2 . The Quality Control procedures state that roles are further defined in individual specific SOPs and LifeSouth should confirm that these will be clearly defined in the individual SOPs.
- Clarification needed on item #7 to confirm when clean room modifications were complete and when clean room requalification was completed.
- Additional information for item#5 which does not have reference to ongoing training in the documents provided.
- Additional information for item #12 for the document provided for cGMP training which does not reference being in compliance with FDA regulations.
- No Outstanding Issues
- No outstanding issues
- Waiting for sponsor to submit table
- No updates at this time
- Major amendment determination
- Timeline Extension: T-con to be set up with sponsor to discuss their timelines (1/16/13)