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The page below is a sample from the LabCE course Patient Safety: Event Management in the Clinical Laboratory (by ASCLS). Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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FDA Requirements

211.22 Responsibilities of quality control unit.
(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.

21 CFR 600.14 and 21 CFR 606.171 require reporting of any event associated with the manufacturing, to include testing, processing, packing, labeling, or storage, or with the holding or distribution of a licensed biological product or a blood or a blood component, in which the safety, purity, or potency of a distributed product may be affected. A manufacturer is required to report to the Center for Biologics Evaluation and Research (CBER), Office of Compliance and Biologics Quality (OCBQ) as soon as possible, but not to exceed 45 calendar days from the date of discovery of information reasonably suggesting a reportable event has occurred.

21 CFR 606.170(b) When a complication of blood collection or transfusion is confirmed to be fatal, CBER, shall be notified by telephone, facsimile, express mail, or electronically transmitted mail as soon as possible; a written report of the
investigation shall be submitted to CBER, within 7 days
after the fatality by the collecting facility in the event of a donor reaction, or by the facility that performed the compatibility tests in the event of a transfusion

21 CFR Part 1271.350(b) requires reporting certain deviations in manufacturing of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P). This rule requires establishments to report, for distributed HCT/Ps, deviations that occurred in their facility or in a facility that performed a manufacturing step for them under contract, agreement, or other arrangement, and that relate to the core Current Good Tissue Practice requirements that are listed in 21 CFR Part 1271.150(b).