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