critical aspects in implementing the oecd monograph 14

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 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)


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


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”


STUDY ORGANIZATIONSTUDY ORGANIZATION

SPONSOR

QA

STUDY DIRECTOR

TEST FACILITY MANAGEMENT A

PI

QA

PI

TEST SITE MANAGEMENT BTEST SITE MANAGEMENT C


RESPONSIBILITIESRESPONSIBILITIES

TEST FACILITY MANAGEMENT

1) TRAINING

2) AREAS

3) CONTAMINATION OF TEST SYSTEMS

4) APPROPRIATE MATERIALS OR TEST KITS



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

√



STUDY PERSONNEL• KNOWLEDGES:

• Aseptic condition and contamination risks

• Biohazard and chemicals



QUALITY ASSURANCE• PROCESSED BASED INSPECTIONS

CELL AND TISSUE CULTURE MEDIA

MORPHOLOGICAL STATUS OF CELLS

POTENTIALCONTAMINATION

CLEANING AND DECONTAMINATION



QUALITY ASSURANCE

PROPERLY USE OF EQUIPMENTCRYOPRESERVATION – FROZEN STORAGESEPARATIONSTERILITY



Otherwise…


FACILITIESFACILITIES

• Equipments- APPROPRIATE

- SEPARATION

• Contamination risks

critical aspects in implementing the oecd monograph 14

Documents