OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008
APPARATUS, MATERIALS AND APPARATUS, MATERIALS AND REAGENTSREAGENTS
• EQUIPMENT: MAINTAINENCE, MONITORING AND CALIBRATION:
• FIXATION OF LIMIT VALUES
• INSTALLATION AND CONTROL OF ALARMS
• REGISTRATION OF DATA
OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008
TEST SYSTEMSTEST SYSTEMS
• CONDITIONS:� Characteristics and maintenance:
Viability and responsiveness
� Culture conditions:
Liquid nitrogen level,
T, RH, CO2 Concentration
Records of manipulations
OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008
TEST SYSTEMSTEST SYSTEMS
• NEWLY RECEIVED TEST SYSTEMS:� DOCUMENTATION
� VIABILITY
� SUITABILITY
• CELLS AND TISSUES
• CONTAMINANTS
� RESPONSIVENESS
OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008
TEST SYSTEMSTEST SYSTEMS
• RECORDS:SOURCE, DATE AND CONDITIONS
PASSAGE
NUMBER
SOURCE- ORIGINAL- IMMEDIATE
FROZEN/THAWING
OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008
TEST SYSTEMSTEST SYSTEMS
• RECORDS
CHRONOLOGY OF CUSTODY
NATURE OF THE TRANSGENE
OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008
TEST AND REFERENCE TEST AND REFERENCE ITEMSITEMS
• THE SAME GENERAL REQUIREMENTS (GLP PRINCIPLES)
• SPECIAL ATTENTION FOR ASEPTIC CONDITIONS
• CONCENTRATION/HOMOGENEITY
• CONTROL ITEMS AFTER THE EXPIRY DATE
OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008
STANDARD OPERATING STANDARD OPERATING PROCEDURESPROCEDURES
• FACILITIES:
• APPARATUS:
• MATERIALS, REAGENTS AND SOLUTIONS:
• TEST SYSTEMS:
• PERFORMANCE:
• QUALITY ASSURANCE:
OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008
PERFORMANCE PERFORMANCE
• TEST ITEMS + CONTROL
• ISSUES
• CHARACTERIZATION OF IN VITRO TEST SYSTEMS
• NUMBERS OF TREATMENT GROUPS AND REPLICATE DETERMINATIONS
• EXPERIMENTAL DESIGN: USE OF POS AND NEG CONTROLS
• ASSAY ACCEPTANCE CRITERIA OR THE ENDPOINTS
• RETENTION OF RECORDS: LOCATION
OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008
REPORTINGREPORTING
• TERM STUDY REPORT
• ADDITION OF CONTROL ITEMS
• PRESENTATION OF HISTORICAL DATA
OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008
ARCHIVINGARCHIVING
• THE SAME CRITERIA (OECD MONOGRAPHS No 1 AND 15)
OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008
CONCLUSIONSCONCLUSIONS
• COMBINATION OF THE OECD MONOGRAPH No 14 (IN VITRO
STUDIES) WITH THE OECD MONOGRAPHS No 1 AND 7
• IN VITRO STUDIES CAN BE CONSIDERED AS SCREENING
METHODS BUT SHOULD BE VALIDATED
• IN VITRO STUDIES ARE COMPLEMENTARY WITH THE IN VIVO
STUDIES
OECD OECD EventEvent , Villa , Villa TuscolanaTuscolana , Frascati (Roma), , Frascati (Roma), ItalyItaly , , AprilApril 10 10 –– 11,11, 2008 2008
Thank you for your attention
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