Process control: Application to the cell processing laboratory

Cytotherapy

Volumn 2, Issue 1, 2000, Pages 63-73

  Keever Taylor, C A ^a,b  

^a MEDICAL COLLEGE OF WISCONSIN   (United States)

^b FROEDTERT MEMORIAL LUTHERAN HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BLOOD CELL; BLOOD COMPONENT; CONFERENCE PAPER; CRYOPRESERVATION; DOCUMENTATION; GOOD LABORATORY PRACTICE; GOOD MANUFACTURING PRACTICE; POLICY; PRACTICE GUIDELINE; PROCEDURES CONCERNING CELLS; PROCESS CONTROL; ARTICLE; BIOLOGICAL THERAPY; BIOTECHNOLOGY; HUMAN; INFORMATION PROCESSING; LABORATORY; LEGAL ASPECT; LEUKOCYTE; MEDICAL RECORD; METHODOLOGY; QUALITY CONTROL; STANDARD; STEM CELL;

BIOLOGICAL PRODUCT;

BIOLOGICAL PRODUCTS; BIOTECHNOLOGY; CRYOPRESERVATION; DOCUMENTATION; FORMS AND RECORDS CONTROL; HUMANS; LABORATORIES; LEUKOCYTES; QUALITY CONTROL; RECORDS; STEM CELLS; TISSUE THERAPY;

EID: 0034115131     PISSN: 14653249     EISSN: None     Source Type: Journal    
DOI: 10.1080/146532400539071     Document Type: Conference Paper

References (11)

1. Guideline for Quality Assurance in Blood Establishments. Docket Number 91N-0450. Center for Biologics Evaluation and Research (HFM-635). Food and Drug Administration, 1995.
2. 21 CFR Part 606 Current Good Manufacturing Practice Regulations for Blood and Blood Components. Code of Federal Regulations, Title 21, Volume 7, Parts 600 to 799, 1999.
3. Proposed Approach to Regulation of Cellular and Tissue-based Products. Food and Drug Administration. Docket Number 97N-0068, 1997.
4. Request for Proposed Standards for Unrelated Allogeneic Peripheral and Placental/Umbilical Cord Blood Hematopoietic Stem/Progenitor Cell Products; Request for Comments. 63 FR 2985, 1998.
5. Code of Federal Regulations (Title 21). Part 210 Current Good Manufacturing Practice In Manufacturing, Processing, Packing, or Holding of Drugs; General, 21 CFR 210-211, 1978.
6. 21 CFR Parts 210 and 211. Current Good Manufacturing Practice: Amendment of Certain Requirements for Finished Pharmaceuticals; Proposed Rule. Federal Register, Vol. 61, No 87, 1996.
7. 21 CFR Parts 808, 812, and 820. Medical Devices; Current Good Manufacturing Practice (cGMP); Final Rule, Quality System Regulation. Federal Register, Vol. 61, No 195, 1996.
8. Guidance for Industry. Human Somatic Cell Therapy and Gene Therapy. US Department of Health and Human Services. Food and Drug Administration. Center for Biologics Evaluation and Research, March 1998.
9. Standards for Hematopoietic Progenitor Cell Collection, Processing and Transplantation, 1st edn. North America, 1996.
10. Standards for Hematopoietic Progenitor Cells. American Association of Blood Banks, 1996.
11. Clinical Laboratory Technical Procedure Manuals, 3rd edn. Approved Guideline; National Committee for Clinical Laboratory Standards (NCCLS) Document GP2-A3, December, 1996.