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What is a biological product deviation report?

The manufacturer of a CDER-regulated product that holds the biological product license and had control over the product when a deviation or unexpected event associated with manufacturing occurred, is required to submit Biological Product Deviation Reports (BPDR) to FDA if the safety, purity, or potency of a distributed CDER - Biological Product Deviations | FDA Food and Drug Administration (.gov) about-fda cder-biological-pro Food and Drug Administration (.gov) about-fda cder-biological-pro

What is FDA reportable in blood bank?

Under 21 CFR 606.171,2, 3 you are required to report certain events associated with the manufacturing, to include testing, processing, packing, labeling, or storage, or with the holding or distribution, of blood or a blood component, which may affect the safety, purity, or potency of a distributed product. Biological Product Deviation Reporting for Blood and Plasma fda.gov media download fda.gov media download

What is the CFR 21 code?

The Code of Federal Regulations Title 21 contains the codified Federal laws and regulations that are in effect as of the date of the publication pertaining to food and drugs, both legal pharmaceuticals and illegal drugs.

What is 21 CFR 7?

A recall is an alternative to an FDA-initiated court action for removing or correcting violative products that have been distributed. 21 CFR 7 sets forth specific recall procedures for FDA to monitor recalls and assess the adequacy of a firms efforts in recall.

Which CFR reference mandates the reporting of biological product deviations?

eCFR :: 21 CFR 600.14 -- Reporting of biological product deviations by licensed manufacturers. 21 CFR 600.14 -- Reporting of biological product deviations by ecfr.gov part-600 subpart-B section-600 ecfr.gov part-600 subpart-B section-600

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