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Vaccines, Blood & Biologics
From: Tull, Lori
Sent: Monday, February 25, 2013 8:38 AM
To: 'Donna Regan'
Subject: Comments from CMC review
The CMC team asked me to forward these comments to you:
1. Your acceptance criteria in your expiry date protocol of within (b)(4) SD of the historical mean, does not sufficiently ensure the quality of the product. For instance, the requirement for -------(b)(4)------- recovery of CD34+ viable cells when the historical mean is (b)(4), does not demonstrate a stable product. Please set your acceptance criteria levels in your expiry date protocol to only allow for minimal product degradation.
2. In the Collection Validation plan, you state that historical data from March 1 and May 31 2012 was used to determine the acceptance values and standard deviation. Please indicate the total number of historical units used for this evaluation.
3. The described procedure for continuous temperature monitoring during transportation is acceptable. However, SOP CL.17.10 states that the technical personnel are instructed to process the cord blood units that meet other acceptance criteria regardless of the data logger visual alarm. The SOP explains that the quality unit evaluates the transportation temperature and determines the final disposition of the unit. The draft SOP TE04.03: Cord Blood Product Disposition Determination (Amendment 9, submitted June 26, 2012) does not specify how units that do not meet the acceptable transportation temperature are handled. In the applicable SOP, please specify that units that don’t meet the acceptable transportation temperature are not qualified for licensure and submit the revised final SOP(s).
4. The submitted draft “Unit Detail Report” is acceptable. Please submit the finalized form and clarify whether the draft “Product Documentation/Tech Review form” that was submitted previously is being removed from the application.
5. We understand that as of October 19, 2012, you have discontinued the CMV (b)(4) testing on the cord blood samples. Please submit the revised “Comprehensive Matched Cord Blood Report” and SOP SE.01.09 that reflect this change in testing.
6. In amendment 9 (June 26, 2012), you submitted the following draft documents:
a. Saint Louis Cord Blood Bank Nursing Instructions for Cord Blood Collections Using the (b)(4) Sterile Cord Blood Collection Unit for Vaginal and Cesarean Deliveries
b. Labor and Delivery Data form including Guidelines for Assessment of Mother and Baby
Please submit the finalized documents.
Lori A. Tull
Regulatory Management Staff
Office of Cellular, Tissue, and Gene Therapies
Center for Biologics Evaluation and Research
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