The challenge of auditing clinical laboratories

Drug Information Journal

Volumn 31, Issue 1, 1997, Pages 197-205

  Desmet, Marian ^b   Linder, Sheila N ^a,c  

^a Pharma Research Quality Assurance   (United States)

^b Marian Desmet bvba   (Belgium)

^c Linder International Inc   (United States)

Author keywords

Audit findings; Central laboratory audits; Clinical laboratories; Clinical trial center; Core laboratory; Good clinical practice; Local laboratory; Process audits; Quality assurance

Indexed keywords

CLINICAL LABORATORY; CLINICAL RESEARCH; CLINICAL TRIAL; CONTRACT; DRUG RESEARCH; GOOD CLINICAL PRACTICE; GOOD LABORATORY PRACTICE; HUMAN; MEDICAL AUDIT; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; TEAMWORK;

EID: 0031053422     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159703100128     Document Type: Review

References (8)

1. Note for Guidance: Good Clinical Practice for Trials on Medicinal Products in the European Community. CPMP; July 11, 1990.
2. Code of Federal Regulations, Title 21, Part 50 (excluding subpart C); Part 56; Part 312 (excluding subpart G); Part 314 (selected sections) (editios 1 April 1993) and Federal Register; Volume 53, Number 31, "Guideline Editions for the Monitoring of Clinical Investigations"; February 17, 1988.
3. Department of Health and Human Services, Part II, 42 CFR Part 405, et al. Clinical Laboratory Improvement Amendments of 1988, Final Rule.
4. Guide de bonne exÉcution des analyses (GBEA). Journal Officiel de la République Francaise. December 4, 1994, "Arrêté du 2 november 1994 relatif à la bonne exécution des analyses de biologie médicale."
5. The Commission of the European Communities. Directive of July 19, 1991, Chapter 3, Data Handling, point 3.2.
6. International Air Transport Association. Dangerous Goods Regulations, Resolution 618, Attachment "a", 35th Edition. January 1, 1994.
7. Organization for Economic Co-Operation and Development. The OECD Principles of Good Laboratory Practice, Environment Monograph No. 45 to No. 48, Paris; 1992.
8. United Kingdom Good Laboratory Practice Compliance Programme, Department of Health. Advisory Leaflet No. 3. London; 1991.