A new international perspective - The application of the principles of GLP to computerized systems (OECD 1995)

Drug Information Journal

Volumn 31, Issue 3, 1997, Pages 883-888

  Doherty, J Bryan ^a  

^a ASTRAZENECA   (United Kingdom)

Author keywords

Computerized systems; Consensus document; GLP principles; OECD

Indexed keywords

ARTICLE; COMPUTER ANALYSIS; DATA ANALYSIS; DRUG FORMULATION; DRUG MONITORING; ENVIRONMENTAL PROTECTION; EUROPE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; JAPAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; UNITED STATES;

EID: 0030854568     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159703100330     Document Type: Article

References (6)

1. Turnheim D. The Organisation for Economic Co-operation and Development, Paris, France .The OECD policy for the implementation of the principles of good laboratory practice. Ann 1st Super Sanità. 1994; 30(4):395-400.
2. The Organisation for Economic Co-operation and Development. The OECD Principles of Good Laboratory Practice. Environment Monograph No. 45. Paris: The Organisation for Economic Co-operation and Development; 1992.
3. The Organisation for Economic Co-operation and Development. The OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, Number 10, GLP Consensus Document, The Application of the Principles of GLP to Computerized Systems, Environment Monograph 116. Paris: The Organisation for Economic Co-operation and Development; 1995.
4. LePore PD, et al. Computerized data systems for non-clinical safety assessment. (The "Red Apple Report") Maple Glen, PA: Drug Information Association; 1988.
5. Environmental Protection Agency. 2185 - Good Automated Laboratory Practices. Principles and Guidance to Regulations for Ensuring Data Integrity in Automated Laboratory Operations with Implementation Guidance. Research Triangle Park, NC: Environmental Protection Agency; 1995.
6. United Kingdom GLP Monitoring Authority. Good Laboratory Practice, Advisory Leaflet Number 1, The Application of GLP Principles to Computer Systems. London: Department of Health, United Kingdom GLP Monitoring Authority; 1995.