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Posted 23 December 2015 | By Zachary Brennan
For manufacturers of non-reproductive human cells, tissues, and cellular and tissue-based products (HCT/Ps), FDA released draft guidance on Wednesday outlining the most frequently reported HCT/P deviations reported to the Center for Biologics Evaluation and Research (CBER).
Under FDA’s authority, a manufacturer of non-reproductive HCT/Ps must investigate and report to the agency all HCT/P deviations related to a distributed product for which the establishment performed a manufacturing step.
The reports have to come within 45 days of the discovery of the event.
The look into which deviations are most frequently reported, as well as examples of which deviations are reportable and non-reportable, comes in addition to FDA’s descriptive scenarios illustrating who must report, what must be reported, and when such reports must be submitted.
FDA has seen a rising number inspections of HCT/P manufacturers over the last decade, and has publically disclosed an untitled letter and a warning letter to such companies in recent years, as well as additional guidance in 2014 and an update on adverse event reporting requirements from earlier this year.
The first HCT/P deviation examples look at companies which distributed an HCT/P and then discovered that it was obtained from an ineligible donor:
As far as examples of non-reportable findings related to donor eligibility, FDA points to:
The following are reportable deviations for donor screening:
As far as examples of non-reportable findings related to donor screening, FDA says:
Examples of companies testing a donor specimen for evidence of infection due to communicable disease agents and finding deviations include:
Examples of non-reportable findings related to donor testing include:
For companies processing each HCT/P in ways that do not cause contamination or cross-contamination, examples of deviations include:
Examples of non-reportable findings related to processing and process controls include:
And finally, as far as examples of reportable HCT/P deviations related to receipt, pre-distribution, shipment and distribution, FDA says:
Examples of non-reportable findings for such products include:
Draft Guidance on Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products
Tags: HTC/P, deviation reports