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OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008
Critical aspects in implementing the OECD Critical aspects in implementing the OECD Monograph 14 Monograph 14 ““ The application of the principles of The application of the principles of
GLP to GLP to in vitroin vitro studiesstudies ””
H. BEERNAERTH. BEERNAERT
Scientific Institute of Public HealthScientific Institute of Public HealthBrussels, BelgiumBrussels, Belgium
[email protected]@iph.fgov.be
OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008
OECD DOCUMENTSOECD DOCUMENTS
• OECD No 14: Advisory Document The Application of th e Principles of GLP to in vitro Studies (2004)
• OECD No 1: Principles on Good Laboratory Practice ( as revised in 1997)
OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008
GOALS OF IN VITRO GOALS OF IN VITRO STUDIESSTUDIES
• test system characterization:
• Facilities: Pre-validation
and validation
• Use of controls and performance standards
• Area of genetic toxicity testing
OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008
DEFINITIONSDEFINITIONS
IN VITRO STUDIES DO NOT USE MULTICELLULAR
WHOLE ORGANISMS BUT RATHER
MICROORGANISMS OR MATERIAL ISOLATED FROM
WHOLE ORGANISMS OR SIMULATIONS THEREOF
AS TEST SYSTEMS. THEY ARE QUALIFIED AS
SHORT-TERM STUDIES
REFERENCE ITEM:CONTROL OF THE PROPER PERFORMANCE OF THE TEST SYSTEM → POSITIVE, NEGATIVE AND/OR VEHICLE CONTROL ITEMS
“ANALYTICAL CHARACTERIZATION”
OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008
STUDY ORGANIZATIONSTUDY ORGANIZATION
SPONSOR
QA
STUDY DIRECTOR
TEST FACILITY MANAGEMENT A
PI
QA
PI
TEST SITE MANAGEMENT BTEST SITE MANAGEMENT C
OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008
RESPONSIBILITIESRESPONSIBILITIES
TEST FACILITY MANAGEMENT
1) TRAINING
2) AREAS
3) CONTAMINATION OF TEST SYSTEMS
4) APPROPRIATE MATERIALS OR TEST KITS
OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008
RESPONSIBILITIESRESPONSIBILITIES
STUDY DIRECTORDOCUMENT THE JUSTIFICATION OF THE TEST SYSTEM →
METHOD SHOULD BE VALIDATED
DOCUMENT THE CHARACTERIZATION OF THE TEST SYSTEM
CELL LINE, AGE, PASSAGE, ORIGIN
+ AND – CONTROLS, QUALITY SUPPLIER
√
OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008
RESPONSIBILITIESRESPONSIBILITIES
STUDY PERSONNEL• KNOWLEDGES:
• Aseptic condition and contamination risks
• Biohazard and chemicals
OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008
RESPONSIBILITIESRESPONSIBILITIES
QUALITY ASSURANCE• PROCESSED BASED INSPECTIONS
CELL AND TISSUE CULTURE MEDIA
MORPHOLOGICAL STATUS OF CELLS
POTENTIALCONTAMINATION
CLEANING AND DECONTAMINATION
OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008
RESPONSIBILITIESRESPONSIBILITIES
QUALITY ASSURANCE
PROPERLY USE OF EQUIPMENTCRYOPRESERVATION – FROZEN STORAGESEPARATIONSTERILITY
OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008
RESPONSIBILITIESRESPONSIBILITIES
Otherwise…
OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008
FACILITIESFACILITIES
• Equipments- APPROPRIATE
- SEPARATION
• Contamination risks