Practice of quality assurance in blood centers - The system and daily work

Vox Sanguinis

Volumn 70, Issue , 1996, Pages 154-157

  Nevalainen, David E ^a  

^a NONE

Author keywords

Good Manufacturing Practice (GMP); ISO 9000; Quality system

Indexed keywords

BLOOD BANK; BLOOD SAMPLING; CONFERENCE PAPER; DOCUMENTATION; GOOD MANUFACTURING PRACTICE; INFORMATION PROCESSING; MEDICAL AUDIT; PRIORITY JOURNAL; QUALITY CONTROL; SAFETY; TRAINING;

EID: 0029888659     PISSN: 00429007     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1423-0410.1996.tb01388.x     Document Type: Article

References (14)

1. Code of Federal Regulations. Food and Drug Administration. Current Good Manufacturing Practice for Manufacture, Processing, Packing or Holding of Drugs.CFR21 -Part 21 0 and 21 1. August 1993.
2. Code of Federal Regulations. Food and Drug Administration. Current Good manufacturing Practice for Blood and Blood Components. CFR21 -Part 606. April 1992.
3. Center for Biologies Evaluation and Research. Food and Drug Administration.Guideline for Quality Assurance in Blood Establishments. Rockville, MD .11 July, 1995.
4. GMP in Blutbanken. Kollegium for Bluttransfusion de Niederlandischen Roten Kreuzes. Amsterdam, Netherlands. September 1993.
5. The rules governing medicinal products in the European Community Volume IV.Guide to Good Manufacturing Practice for Medicinal Products, Luxemburg, 1989.
6. Bonnes Practiques de Qualification Biologique du Don. Journal Officiel de la Republique Francaise. 31 Janvier, 1995.
7. UKBTS/NIBSC Liaison Group. Guidelines for the BLOOD TRANSFUSION SERVICE. HMSO Publication Centre, London, England. 2nd Ed., 1993.
8. The Quality Program. American Association of Blood Banks. Bethesda, MD, 1994.
9. Nevalainen, DE and MF Callery. Quality Systems in the Blood Bank and Laboratory Environment. American Association of Blood Banks. Bethesda, MD, 1994.
10. Nevalainen, DE and MF Callery. Applying Self-Assessment and Process Analysis to Create a Quality System. American Association of Blood Banks. Bethesda, MD, 1995.
11. Nevalainen, DE and HL Lloyd. ISO 9000 quality standards: a model for blood banking? Transfusion. Vol. 34 No.6: 521-52, 1995.
12. Harvey H, C Hewison, DE Nevalainen and HL Lloyd. Maintaining Quality in Blood Banking. Blood Reviews 9:15-24. 1995.
13. Nevalainen, DE and NM Gallery. Quality systems and total process control in blood banking. Transfusion 34 No. 10:899-906, 1994.
14. ISO 9002. Quality systems-Model for quality assurance in production, installation, and servicing. International Organization for Standardization. Geneva, Switzerland, 1994