SCOPUS 정보 검색 플랫폼

Transfusion Medicine

Volumn 22, Issue 1, 2012, Pages 5-43

Guidelines for validation and qualification, including change control, for hospital transfusion laboratories

(9) Allard, S a Burgess, G b Cuthbertson, B c Elliott, C d Haggas, R e Jones, J f Robertson, B g Sadani, D h Smith, K b

a ROYAL LONDON HOSPITAL (United Kingdom)

b NHS BLOOD AND TRANSPLANT (United Kingdom)

c SCOTTISH NATIONAL BLOOD TRANSFUSION SERVICE (United Kingdom)

d JAMES COOK UNIVERSITY HOSPITAL (United Kingdom)

e LEEDS GENERAL INFIRMARY (United Kingdom)

f WBS (United Kingdom)

g GUY'S AND ST THOMAS' NHS FOUNDATION TRUST (United Kingdom)

h Leeds Blood Centre (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CHANGE CONTROL; CLINICAL PROTOCOL; HOSPITAL LABORATORY; HOSPITAL MANAGEMENT; HOSPITAL PLANNING; HOSPITAL POLICY; MEDICAL DOCUMENTATION; NOTE; PRACTICE GUIDELINE; PROCESS DESIGN; QUALIFICATION PROCESS; RISK ASSESSMENT; STAFF TRAINING; TOTAL QUALITY MANAGEMENT; TRANSFUSION; VALIDATION PROCESS;

BLOOD TRANSFUSION; HUMANS; LABORATORIES, HOSPITAL; QUALITY OF HEALTH CARE;

EID: 84863410929 PISSN: 09587578 EISSN: 13653148 Source Type: Journal
DOI: 10.1111/j.1365-3148.2011.01124.x Document Type: Note

Times cited : (6)

References (10)

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2
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- EU GMP, Annex 20.
- EU GMP, Annex 20.

3
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- European Commission Working Party on Control of Medicines and Inspections Final Version of Annex 15 to the EU Guide to Good Manufacturing Practice 2001.
- European Commission Working Party on Control of Medicines and Inspections Final Version of Annex 15 to the EU Guide to Good Manufacturing Practice 2001.

4
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- European Union (EU) Directive 2002/98/EC.
- European Union (EU) Directive 2002/98/EC.

5
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- ISBT guidelines for the validation of automated systems in blood establishments.
- ISBT.
- ISBT. (2010)ISBT guidelines for the validation of automated systems in blood establishments. Vox Sanguinis, 98(Suppl. 1), 1-19
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6
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- ISPE. ISBN 1-931879-61-3
- ISPE. 2008.GAMP 5 A Risk-based Approach to Compliant GxP Computerised Systems. ISBN 1-931879-61-3
- (2008) GAMP 5 A Risk-based Approach to Compliant GxP Computerised Systems.

7
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- NPSA. Healthcare risk assessment made easy.
- NPSA. (2007)Healthcare risk assessment made easy.
- (2007)

8
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- Pharmaceutical Inspection Co-operation Scheme PIC/s.GMP Guide for Blood Establishments 2007.
- Pharmaceutical Inspection Co-operation Scheme PIC/s.GMP Guide for Blood Establishments 2007.

9
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- Recommendations for evaluation, validation and implementation of new techniques for grouping, antibody screening and crossmatching.
- Scott et al.
- Scott et al. (1995)Recommendations for evaluation, validation and implementation of new techniques for grouping, antibody screening and crossmatching. Transfusion Medicine, 5, 145-150.
- (1995) Transfusion Medicine , vol.5 , pp. 145-150

10
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- The Blood Safety & Quality Regulations 2005 No. 50 as amended (the principal Regulations) were signed by authority of the Secretary of State for Health, as were the amending Regulations (Si 2005/1098, Si 2005/2898, Si 2006/2013 & si 2007/604).
- The Blood Safety & Quality Regulations 2005 No. 50 as amended (the principal Regulations) were signed by authority of the Secretary of State for Health, as were the amending Regulations (Si 2005/1098, Si 2005/2898, Si 2006/2013 & si 2007/604).

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