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Vaccines, Blood & Biologics
RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA Submission ID: 125391/0 Office: OCTGT
Hematopoietic Progenitor Cells,Cord (HPC-C)
Telecon Date/Time: 03-October-2011 11:30 AM Initiated by FDA? Yes
Telephone Number: -------(b)(4)--------
1. Advice – 483 responses, ICF, DE and product clarifications
Author: RAMANI SISTA
Clarification: 483 responses, ICF, DE and product clarifications
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
DMPQ – 483 responses
The Sponsor had submitted their responses to FDA issues 483 when the Sponsor’s facilities were inspected in August. FDA provided feedback on the items from the 483 and informed the Sponsor if the item was adequately addressed or needed additional information.
Item 1a: Quality Unit. FDA stated that the information presented was a marked improvement, the titles of SOPs are well defined, but there is still comingling of other information. A quality management plan will suffice. For example SOP B100.5 defined the roles and responsibilities of personnel, but also included information on validation which should be limited to validation SOP. The sponsor stated that they included the information, that they felt was useful and was easy to refer back if need be. FDA then suggested titling the SOP as “Quality Management Overview” and then subtitling the SOP, to which the Sponsor agreed.
Regarding the SOP on signatory authority, the SOP has to be more specific since it was not clear who would sign off. The Sponsor stated that they have another SOP for signatory authority, which FDA requested to see. FDA asked the Sponsor to explain the schematics of 5014. FDA also stated that the signatory SOP is very useful to keep handy in the event of future inspections, since the inspectors are used to seeing this information in other facilities they would expect the Sponsor to have it too.
FDA advised the Sponsor to improve their Quality Management SOPs, to specifically define the roles of each quality unit, - process improvement, design control, and change control, and specifically state what they are doing. The Sponsor stated that they have set up a cord blood quality unit that reviews every aspect of production; they have all the adequate documentation that they could stratify in to the three quality units.
FDA advised the Sponsor to better define their quality unit, go through all their appropriate SOPs and have one document to review with some overview information rather than having a Quality Unit subheading and cross referencing another SOP. It was also beneficial to have the signatory authority information in the quality unit.
The Sponsor asked if they can send the updated document via email to the DMPQ team, to which the FDA agreed.
Item 1b-d: Sponsor responses are acceptable.
Item 2: Batch production records are a huge improvement and are acceptable
Item 3: Aseptic Technology was addressed by Dr. Yong Fan, correction is acceptable
Item 4: Has been addressed and the SOP is acceptable
Item 5: Sponsor committed to provide the information in November, this plan is acceptable.
Item 6 a&b: Responses are adequate.
Item 7 a, b & c: Responses are adequate
Item 7d: Freezer validation is not adequate.
Sponsor stated that they are waiting for the completion of the assay validation before they can revalidate the ------(b)(4)----- freezers. FDA requested the Sponsor to include CD34 cells too. The Sponsor stated they were ready to revalidate the (b)(4) and TNC assay, but were unsure how to proceed with these assays. FDA’s product chair, Dr. Fan offered to speak with the Sponsor at a later time to provide more information. The Sponsor stated they would submit all the information in November.
Item 8: a. Addressed and complete
b. Will be completed by November
Item 9: a. Response acceptable
c. Submit a summary report.
Item 10: Will be completed in November, which is acceptable.
Summary of pending items from 483
1a – Quality Plan
5 – Complete summary report for growth promotion
7 – Freezer validation to be completed
9c – Validation submitted, summary report will be submitted when completed
10 – Complete summary report will be submitted when completed