11

Riassunto• Recent Activities undertaken by the OECD Working Group on GLP• Dian Turnheim• Environment, Health and Safety Division, Environment Directorate, Organisation for

Economic Co-operation and Development, 2, rue André Pascal, 75775 Paris CEDEX 16, Francia

• E-mail, dian.turnheim@OECD.org• The OECD Working Group on Good Laboratory Practice (GLP) is the body which

oversees all the work in OECD related to the GLP Principles and GLP compliance monitoring. Comprising the representatives of all the GLP compliance monitoring authorities in OECD member countries and adhering non-members, it is especially concerned with international harmonisation and liaison in view of Mutual Acceptance of Data (MAD).

• This presentation by the OECD Secretariat will explain how the Working Group functions and some of the major results it has achieved since its establishment by the Joint Meeting of the Chemicals Committee and Working Party on Chemicals, Pesticides and Biotechnology in 1990. A brief explanation of the legally-binding OECD Council Acts related to MAD will set the scene.

• Details on recent activities will be provided, including the plans for a continuing programme of on-site evaluations of national GLP compliance monitoring programmes; the recent position paper on “outsourcing” of inspection functions and the forthcoming advisory document on archiving in a GLP environment; the status of work with non-members in the framework of their adherence to the MAD system; plans for a Working Group event aimed at a dialogue with industry; and other projects and outputs of the Working Group.

22

XI Corso di Buona Pratica di Laboratorio6-7 December 2006, Rome

Recent Activities undertaken by the OECD Working Group on GLP

Dian Turnheim, Deputy HeadEHS Division, OECD

Dian.Turnheim@oecd.org

33

Harmonisation for Mutual Acceptance of Data

OECD COUNCIL ACTS ONGOOD LABORATORY PRACTICE

• 1981 Council Decision on Mutual Acceptance of Data inthe Assessment of Chemicals [C(81)30/Final]

• 1989 Council Decision/Recommendation on Compliancewith Principles of Good Laboratory Practice[C(89)87/Final]

• 1997 Council Decision on Adherence of Non-MemberCountries to the Council Acts related to the MutualAcceptance of Data [C(97)114/Final]

44

OECD Council Acts related to GLP - 1981

OECD PRINCIPLES OF GOOD LABORATORY PRACTICE

Integral part of 1981 Council Decision on MAD (Annex II)

“Decides that data generated in the testing of chemicals in an OECD Member country in accordance with OECD Test Guidelines and OECD Principles of Good Laboratory Practice shall be accepted in other Member countries for purposes of assessment and other uses relating to the protection of man and the environment.”

55

OECD Council Acts related to GLP - 1981

ANNEXED TO 1981 MAD DECISION

continuing work in the Environment, Health

and Safety Programme

OECD Guidelines for the Testing of Chemicals

OECD Principles of Good Laboratory Practice

Updating Programme

Work to facilitate harmonizedapproaches to GLP compliance

and interpretation of GLP Principles

66

OECD Council Acts related to GLP - 1981

HARMONISATION FOR MUTUAL ACCEPTANCE OF DATA

THEORY

• Policy: 1981 Council Decision

• Tools: Test Guidelines/GLP Principles

PRACTICE

• Use of Test Guidelines: straightforward

• Compliance with GLP: statement by laboratory

POTENTIAL PROBLEMS

• Verification of compliance

• Recognition of national compliance monitoring procedures

• Disharmonised national tools

77

OECD Council Acts related to GLP - 1989

1989 COUNCIL DECISION - RECOMMENDATION ONCOMPLIANCE WITH PRINCIPLES OF

GOOD LABORATORY PRACTICEC(89)87(Final)

I. Compliance Monitoring:

Decides that national Compliance MonitoringProcedures be implemented (1983 Recommendation)

• based on laboratory inspections and study audits• national compliance monitoring authority• certification of GLP compliance by test facility

Recommends application of guidance in Annexes

88

OECD Council Acts related to GLP - 1989

ANNEXES: GUIDANCE FOR COMPLICANCE MONITORING

Annex I: Revised Guides for Compliance MonitoringProcedures (1995)

Annex II: Revised Guidance for the Conduct of Laboratory Inspections and Study Audits(1995)

Annex III: Revised Guidance for the Exchange of Information Concerning NationalProgrammes for Monitoring Compliance withPrinciples of GLP (1995)(includes guidance for the preparation ofannual overview of facilities inspected)

99

OECD Council Acts related to GLP - 1989

1989 COUNCIL DECISION - RECOMMENDATION ONCOMPLIANCE WITH PRINCIPLES OF

GOOD LABORATORY PRACTICEC(89)87(Final)

II. International Aspects:

Decides that countries recognize assurance by anothercountry that data have been generated under GLP, ifthere is:

1) authority(ies) for international liaison2) exchange of relevant information3) information on GLP compliance of a specific

laboratory

1010

OECD Council Acts related to GLP - 1989

COUNTRY A COUNTRY B

SubmitsTEST FACILITYREGULATORY AUTHORITY

Data

Requests Information onGLP Compliance Status

of the Laboratory or Study Audit

Information

Inspection and/orStudy Audit

Information

Report

GLP MONITORING AUTHORITY GLP MONITORING AUTHORITY

Requests Information

1111

Harmonisation for Mutual Acceptance of Data

1981 MAD Decision (with

GLP Principles)+

1989 Decision -Recommendation on

Compliance with GLP (with guidance for compliance for

monitoring)

= THEORETICAL Basis for Ensuring

Confidence

In practice:OECD assists Member countries to implement these Council Acts

1990: OECD Working Group on GLP

1998: Evaluation through Mutual Joint Visits (on-site evaluation)

2006: Continuing Programme of on-site evaluation visits

OECD assists non-Member countries to implement GLP and Compliance Monitoring

1997: Council Decision on Adherence of non-Member countries

1212

Harmonisation of Compliance Monitoring Procedures

INFORMATION EXCHANGE

GOAL: Recognition (by Country A) of Country B’s assurance thatspecific data have been generated under GLP

MEANS: Country A’s confidence in Country B’s procedures forMonitoring Compliance with GLP

BASED IN: Knowledge and understanding of Country B’s procedures

OECD’S ROLE: Working Group on GLP

• Promote the flow of information• Establish harmonized procedures• On-site evaluations

1313

Harmonisation of Compliance Monitoring Procedures

OECD WORKING GROUP ON GLP• Comprises representatives of national Monitoring Authorities (~ 40)

• Meets at least once a year (reports to the Chemicals Committee)

• Discusses administrative and policy issues related to harmonisationof compliance monitoring and international liaison

• Exchange of information

• Harmonisation of inspection procedures

• Oversight of OECD activities on GLP-- Training Courses-- Consensus Workshops / Consensus Documents-- Advisory Documents-- Non-Member Countries

• Review of implementation of Council Acts by Member countries-- on-site evaluation visits (MJVs)

1414

OECD Series - GLP/Compliance Monitoring

1. OECD GLP Principles 2. Guidelines for Compliance Monitoring 3. Guidelines for Conduct of Inspections and Study Audits 4. Quality Assurance and GLP 5. Compliance of Laboratory Suppliers 6. Application of GLP to Field Studies 7. Application of GLP to Short-term Studies 8. Role/Responsibility of Study Director 9. Guidance for Preparation of Inspection Reports 10. Application of GLP to Computer Studies 11. Role/Responsibility of Sponsor 12. Requesting/Carrying Out Inspections and Study Audits in Another Country 13. The Application of the OECD Principles of GLP to the Organisation and Management of Multi-Site Studies 14. The Application of the Principles of GLP to in vitro Studies [15. Archiving in a GLP Environment

Type

standards

CM

CM

Consensus Document

Consensus Document

Consensus Document

Consensus Document

Consensus Document

CM

Consensus Document

Advisory Document

Advisory Document

Consensus Document

Consensus Document

First Adopted

1981

1992

1992

1992

1992

1992

1993

1993

1995

1995

1998

2000

2002

2004

2007]

Revised

1997

1995

1995

1999

1999

1999

1999

1999

Env. Mono

(98)17

110

111

(99)20

(99)21

(99)22

(99)23

(99)24

115

116

(99)16

(00)3

(02)9

(04)26

1515

Harmonisation of Compliance Monitoring Procedures

Document on Archiving Drafting Group under the Working Group on GLP (Lead: NL) – since 2004

Draft Document : “Establishment and Control of Archives that Operate in Compliance with the Principles of GLP” (April 2006)

• Roles and responsibilities of sponsor, management, contract archive services, study personnel, QA, etc.

• Archive facilities/security

• Archiving procedures

• Archiving electronic records

• Closure of an archive

Working Group comments (first national consultations) (October 2006)

Revised Draft to Working Group (February 2007) – for endorsement and next steps

1616

Harmonisation of Compliance Monitoring Procedures

Position Paper on ‘Outsourcing of Inspection Functions”(declassified by the Joint Meeting of the Chemicals Committee and Working Party on

Chemicals, Pesticides and Biotechnology, June 2006)

1989 Council Act on Compliance with GLP – Annex I: Guides for Compliance Monitoring Procedures

• Countries must designate an authority(ies) to discharge the functions required by the procedures for monitoring compliance and international liaison

Administrative and legal functions

National Compliance Monitoring Authority is responsible for

• implementing procedures, i.e. ensuring that inspectors are available (staff, contracted - domestic, foreign)

• taking decisions on compliance status of facilities and the quality of studies audited and taking any action based thereon

• outsourcing of inspection functions is possible, not necessarily recommended –can be useful for new monitoring authorities

1717

Harmonisation of Compliance Monitoring Procedures

Continuing Programme of on-site evaluation visits(Endorsed by Joint Meeting of the Chemicals Committee and Working Party on

Chemicals, Pesticides and Biotechnology, November 2006)

Procedures and processes based on MJV pilot project (1998-2002)

• All Monitoring Programmes, including non-member adherents

• Smaller teams

• More detailed procedures, guidance

• Harmonized reporting

Central management (OECD Secretariat) and funding (all governments)

Oversight by Working Group on GLP

2008-2017 first round

1818

OECD Council Acts related to GLP - 1997

NON-OECD COUNTRIES ANDMUTUAL ACCEPTANCE OF DATA

Council Decision on Adherence of Non-Member Countries to Council Acts Related to MAD: C(97)114/Final

Harmonisation of Standards

Possibility of Adhering to OECD Council Acts:

• C(81)30(Final): implementation of GLP and Test Guidelines in test facilities

-- participate in Test Guidelines Programme

• C(89)87(Final): establishment of national compliancemonitoring authority

-- participate in GLP Working Group

1919

MAD and Non-Member Countries

Rights of, and Obligations of Non-Member Countries adhering to the OECD Council Acts related to the Mutual Acceptance of Data

Data developed in test facilities in non-Member countries in accordance with C(81)30 (Final),

• OECD Guidelines for Testing of Chemicals, and

• OECD Principles of GLP,

will be accepted by OECD countries and non-Member countries adhering to MAD system for the purpose of assessment of chemicals, pesticides, pharmaceuticals, etc.

IF……………

2020

MAD and Non-Member Countries

…………..IFNational GLP Compliance Monitoring Procedures in the non-Member country have been shown to be in accordance with those in OECD Countries [C(89)87/Final], i.e.:

• are based on laboratory inspections and study audits

• are overseen by a national GLP compliance monitoringauthority designated by government

• require declarations of compliance by laboratorymanagement

• apply OECD guidance in Annexes to C(89)87/Final

• successful on-site evaluation visit

2121

MAD and Non-Member Countries

In the same spirit:

Data developed in OECD countries (and non-Member countries adhering to MAD) under the same conditions will be accepted by the non-Member country in question.

MUTUAL ACCEPTANCE OF DATA IN THE ASSESSMENT OF CHEMICALS:

• avoids duplication• saves resources• reduces animal testing• eliminates non-tariff trade barriers• creates a level playing-field• reduces time-to-market

2222

Mutual Acceptance of Data

3 Council Decisions accepted by:

• 1981 MAD• 1989 Compliance• 1997 Non-Members

Mutual Recognition

30 Member countries

AUS, AU, BE, CAN, CZ, DK, FIN, FR, GER, GR, HU, ICL, IRE, IT, JP, KO, LU, MEX,

NL, NO, NZ, PO, PT, SK, SP, SWE, SWI, TU, UK, USA

Non-Member countries• South Africa 2003• Slovenia 2004• Israel 2005

ProvisionalIndia (2003) Argentina (2006) (Chinese Taipei)

BrazilChina

SingaporeRussia

etc.

2323

MAD and Non-Member Countries

OECD Working Group on GLP

• Ensures harmonisation of GLP compliance monitoring amongcountries

• establishes agreed procedures

• examination of compliance monitoring programmesthrough on-site evaluation visits

• Non-Member countries adhering to MAD system

• use agreed procedures

• take part in development of further guidance

• are subject to on-site evaluation visits

2424

Harmonisation of Compliance Monitoring Procedures

OTHER ACTIVITIES OF WORKING GROUP

• Planning for an event with industry : better cooperation among receiving authorities, monitoring authorities and industry (MAD) Lead: Italy

• Exchange of information on facilities inspected/study audits carried out

• New monitoring authorities in member countries –integrate into system

• Training courses for GLP inspectors (8th in Edinburgh, September 2006)

2525

Harmonisation for Mutual Acceptance of Data

HARMONISATION IN THE AREA OF GLP

• OECD Principles of GLP: a single standard for testfacilities throughout OECD and for all chemicalsubstances

• GLP Compliance Monitoring: mutually acceptableprocedures

• Interpretation of GLP Principles: Consensus Documents,Advisory Documents

• International liaison: network of national MonitoringAuthorities (Working Group on GLP) including non-member countries

• [Regulatory requirements: scope of application of GLP]

2626

OECD

GLP WEBSITE:

HTTP://WWW.OECD.ORG/ENV/GLP