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Fda 3486 2017-2024 Form
Video instructions and help with filling out and completing Form FDA 3486 FDA 3486 Biological Product Deviation Report
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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 ... -
Which CFR reference mandates the reporting of biological product deviations?
eCFR :: 21 CFR 600.14 -- Reporting of biological product deviations by licensed manufacturers. -
What is the FDA guidance on deviations?
Under 21 CFR 600.14(c), you should report a biological product deviation as soon as possible, but you must report at a date not to exceed 45 calendar days from the date that you, your agent, or another person who performs a manufacturing, holding, or 11 Page 14 Contains Nonbinding Recommendations distribution step ... -
What is the definition of a biological product?
Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. -
How does FDA define deviation?
Food and Drug Administration (FDA): In the FDA's guidance on quality management systems for the pharmaceutical industry and current Good Manufacturing Practice (cGMP) regulations, a deviation is described as a result that falls outside the expected range or fails to fulfill a specific requirement. -
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. -
Which CFR reference mandates the reporting of biological product deviations?
eCFR :: 21 CFR 600.14 -- Reporting of biological product deviations by licensed manufacturers. -
What is a biological product deviation?
Biological product deviation (BPD) refers to unexpected events in manufacture, storage or distribution that deviate from the standard operating procedure. BPD reporting is mandated by the FDA and governed by title 21 of the Code of Federal Regulations (CFR)
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