Data management in the cell therapy production facility: The batch process record (BPR)

Cytotherapy

Volumn 10, Issue 3, 2008, Pages 227-237

  Janssen, W E ^a  

^a H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

Author keywords

Batch process record (BPR); Cellular therapy processing; Data management; Database; Electronic records; Manufacturing; Records

Indexed keywords

ACCREDITATION; ANALYTICAL ERROR; BATCH PROCESS; CELL THERAPY; CLIENT SERVER APPLICATION; COMPUTER PROGRAM; COMPUTER SECURITY; CONFIDENTIALITY; ELECTRONIC SPREADSHEET; GOOD MANUFACTURING PRACTICE; INFORMATION PROCESSING; LEGAL ASPECT; NEEDS ASSESSMENT; PRIORITY JOURNAL; PROCESS CONTROL; PROCESS DESIGN; PRODUCT DEVELOPMENT; QUALITATIVE ANALYSIS; QUALITY CONTROL; REVIEW; TOTAL QUALITY MANAGEMENT; VALIDATION PROCESS; BIOLOGICAL THERAPY; DATA BASE; DISASTER; HUMAN; MEDICAL RECORD; METHODOLOGY;

DATABASE MANAGEMENT SYSTEMS; HUMANS; MEDICAL RECORDS SYSTEMS, COMPUTERIZED; NATURAL DISASTERS; RESEARCH DESIGN; TISSUE THERAPY;

EID: 42449103985     PISSN: 14653249     EISSN: 14772566     Source Type: Journal    
DOI: 10.1080/14653240802020399     Document Type: Review

References (14)

1. United States Code of Federal Regulations (2005) Human Cells, Tissues, Cellular and Tissue-based Products, 21CFR1271 (Updated 2005), U.S. Government Printing Office, Washington, DC
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3. AABB (2007) Standards for Cellular Therapy Product Services, AABB, Bethesda
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5. United States Code of Federal Regulations (2005) Current Good Manufacturing Practices, 21CFR210-211 (Updated 2005), U.S. Government Printing Office, Washington, DC
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