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GUIDANCE DOCUMENT

Guideline for Quality Assurance in Blood Establishments July 1995

Final
Docket Number:
91N-0450
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

The purpose of this guideline is to assist manufacturers of blood and blood components, including blood banks, transfusion services, and plasmapheresis centers, in developing a quality assurance (QA) program in their effort to be consistent with recognized principles of quality assurance and current good manufacturing practice (CGMP).


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 91N-0450.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010