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Biological product deviation reporting for blood and plasma establishments
Biological product deviation reporting for blood and plasma establishments
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body. - Publication:
- Silver Spring, MD : Center for Biologics Evaluation and Research, March 2020
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Biological Products
Blood Banks -- standards
Mandatory Reporting
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration - Genre(s):
- Technical Report
- Abstract:
- We, FDA, are providing you, a blood or plasma establishment, with revised recommendations related to biological product deviation (BPD) reporting. This guidance document is intended to assist blood and plasma establishments in determining when a report is required, who submits the report, what information to submit in the report, the timeframe for reporting, and how to submit the report. The revised guidance explains that we do not consider post donation information (PDI) events to require BPD reports. PDI includes information that a donor, or other reliable source, provides to a blood establishment after a donation (e.g., at a subsequent donation) that would have resulted in deferral of the donor had you known the information at the time of donation. The revised guidance also contains other technical updates and editorial revisions to improve clarity and provide a more streamlined document. FDA is also announcing the withdrawal of two obsolete memoranda to blood establishments entitled, "Responsibilities of Blood Establishments Related to Errors & Accidents in the Manufacture of Blood & Blood Components," issued March 20, 1991, and "Guidance Regarding Post Donation Information Reports," issued December 10, 1993. For the purposes of this document, "blood and plasma establishment" includes licensed manufacturers of blood and blood components, including Source Plasma, unlicensed registered blood establishments, and transfusion services. This guidance document supersedes the guidance entitled "Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments," dated October 2006.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (i, 27 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 101772639 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/101772639