The applicability of cGMP to cord blood cell banking

Journal of Hematotherapy and Stem Cell Research

Volumn 5, Issue 2, 1996, Pages 135-137

  Zuck, Thomas F ^a  

^a UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BLOOD BANK; CONFERENCE PAPER; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; HEALTH CARE POLICY; HUMAN; MEDICAL RESEARCH; PRIORITY JOURNAL; QUALITY CONTROL; UMBILICAL CORD BLOOD;

BLOOD BANKS; CELL TRANSPLANTATION; CLINICAL TRIALS; FETAL BLOOD; GUIDELINES; HEMATOPOIETIC STEM CELLS; HUMANS; INFANT, NEWBORN; LICENSURE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0029875578     PISSN: 15258165     EISSN: None     Source Type: Journal    
DOI: 10.1089/scd.1.1996.5.135     Document Type: Article

References (9)

1. 58 FR 53247. Federal Register. October 14, 1993.
2. Newsletter. Council of Community Blood Centers, Washington, DC, December 15, 1995, p. 7.
3. CBER. Draft document concerning the regulation of placental/umbilical cord blood stem cell products intended for transplantation or further manufacturing into injectable products. December 13, 1995.
4. Section 601.10 Title 21 CFR.
5. 57 FR 55544. Federal Register. November 25, 1992.
6. Zuck, T.F. Current good manufacturing practices. Transfusion 35:955, 1995.
7. Quality Assurance Guidelines for Blood Establishments Center for Biologies Evaluation and Research, Bethesda, MD, 1995.
8. Validation of Computer Systems in Blood Establishments. Center for Biologics Evaluation and Research, Bethesda, MD, 1993 (draft).
9. Letter to computer software vendors. Center for Biologies Evaluation and Research, Bethesda, MD, March 31, 1994; 59FR 44991. Federal Register. August 31, 1994.