O1

Implementation of OECD Principles in

Etty Feller, M.Sc

Israel Laboratory Accreditation authority

OECD Event, Villa Tuscolana, Frascati (Roma), Italy, April 10 – 11, 2008
Diapositiva 1

O1 Orna; 03/04/2008
Quality System (description)
A model for gaining quality assurance related to design,
development, production, testing, installation and
service.
Quality management system within which the
organisation operates and has the ability to provide the
services as required OECD-GLP (Organization for
Economic Co-operation and Development Good
Laboratory practice) / ISO/IEC 17025

OECD Event, Villa Tuscolana, Frascati (Roma), Italy, April 10 – 11, 2008
The ISO/IEC 17025 describes the Quality
system (requirements) of a laboratory.
Addresses issues which affect the test result
such as: sampling, uncertainty, traceability,
opinions and interpretations, service to the
customer, calibration and more.

OECD Event, Villa Tuscolana, Frascati (Roma), Italy, April 10 – 11, 2008
The ISO/IEC 17025
Specified or self developed analytical methods
which are requested upon submission by the
customer, to analyze an unknown samples.
ISO/IEC 17025 accredited test methods are
generally routinely used to generate test result
They also may be developed by the laboratory).

OECD Event, Villa Tuscolana, Frascati (Roma), Italy, April 10 – 11, 2008
 GLP testing facilities
Non-clinical studies that include supporting
tests for:
* Research in developing a new drug or
active material
* Certifying a new pesticide
* Compliance of new medical device, new
equipment
* Monitoring air pollution etc.

OECD Event, Villa Tuscolana, Frascati (Roma), Italy, April 10 – 11, 2008
GLP studies are:
Pre-determined experiments ( more than one test
method may be used) agreed upon by the
sponsor before commencing the work.
Related to registration or license of product for
use

OECD Event, Villa Tuscolana, Frascati (Roma), Italy, April 10 – 11, 2008
The main difference between an accredited
laboratory according to ISO/IEC 17025 and a
research facility working according to the
OECD-GLP series of principles are the type of
projects that the laboratories deal with.

OECD Event, Villa Tuscolana, Frascati (Roma), Italy, April 10 – 11, 2008
Subject ISO/IEC 17025 OECD-GLP
Reagents Defined in Certified, fully traceable, with
and section 5.6.3.2 appropriate documentation from the
solutions where possible customer or supplier regarding the
should be expiry date, storage , stability and
traceable to SI homogeneity and purity. The
units or to analyst should also record these
certified details in the study when used. All
reference reference substances in GLP need
materials to be registered on reception and
usage uniquely identified as a
reference or working standard

OECD Event, Villa Tuscolana, Frascati (Roma), Italy, April 10 – 11, 2008
Subject ISO/IEC 17025 OECD-GLP
Control Defined in section Planned amendments to the
of 4.3.3 the lab should study protocol should be
changes define how changes documented and signed by the
are made in study director. Non planned
documents deviations should be
maintained with the study.

OECD Event, Villa Tuscolana, Frascati (Roma), Italy, April 10 – 11, 2008
Subject ISO/IEC 17025 OECD-GLP
Archive As requested by Defined requirements
facilities the customer Archivist, which documents,
test items and for how long.
Requirements for all the
peripheral support equipment,
computer software

OECD Event, Villa Tuscolana, Frascati (Roma), Italy, April 10 – 11, 2008
Subject ISO/IEC 17025 OECD-GLP
Animal related No reference Emphasized
laboratory work,
forms a major part of
GLP

OECD Event, Villa Tuscolana, Frascati (Roma), Italy, April 10 – 11, 2008
OECD-GLP specific Overlapping subjects ISO/IEC 17025 specific

Studies Services
Management
Master schedule Training
Complaints
Study director Reference materials
Uncertainty of
Archivist Equipment &
measurement
Quality Assurance maintenance
Proficiency testing
Unit Reports
Preventive actions
Study Plan Sampling
Service to the client
Current training Sample reception
Test article and Audits
system Corrective actions
Chain of custody Method Validation
Inspection monitoring Quality control
procedures

OECD Event, Villa Tuscolana, Frascati (Roma), Italy, April 10 – 11, 2008