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GLP & Quality Assurance. หนึ่งฤทัย แสแสงสีรุ้ง กรมวิทยาศาสตร์บริการ30 สิงหาคม 2548. Relative between REACH and GLP. Safety Data Sheet (SDS) physico-chemical properties : 20 items Toxicological studies : 41 items Ecotoxicological studies : 10 items. Outline. What is the GLP?

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Glp quality assurance

GLP & Quality Assurance

หนึ่งฤทัย แสแสงสีรุ้ง กรมวิทยาศาสตร์บริการ30 สิงหาคม 2548


Relative between reach and glp
Relative between REACH and GLP

  • Safety Data Sheet (SDS)

    • physico-chemical properties : 20 items

    • Toxicological studies : 41 items

    • Ecotoxicological studies : 10 items


Outline
Outline

  • What is the GLP?

  • Why do Thailand’s laboratory need the GLP?

  • What is a difference between GLP & ISO 17025?

  • What is the MAD program?



GLP

  • GLP = Good Laboratory Practice

  • OECD Principles on Good Laboratory Practice

  • What is the OECD?


The organization for economic co operation and development oecd
The Organization for Economic Co- operation and Development : OECD

  • Intergovernmental organization

  • 30 industrialized countries

  • Meet to co-ordinate and harmonize policies.

  • Discuss issues of mutual concern

  • Work together to respond to international problems.


30 industrialized countries
30 industrialized countries : OECD

Australia

Austria

Belgium

Canada

Czech Republic

Denmark

Finland

France

Germany

Greece

Poland

Portugal

Slovak Republic

Spain

Sweden

Switzerland

Turkey

UK

USA

Norway

  • Hungary

  • Iceland

  • Ireland

  • Italy

  • Japan

  • Korea

  • Luxembourg

  • Mexico

  • Netherlands

  • New Zealand


The purpose of glp
The purpose of GLP : OECD

  • The principle of Good laboratory practice (GLP) : to promote the development of quality and validity of test data used for determining the safety of chemicals and chemicals product.


Definition of glp
Definition of GLP : OECD

  • GLP is a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.


Scope of principle of glp
Scope of principle of GLP : OECD

  • GLP should be applied to the non-clinical safety testing of test items:

    • Pharmaceutical product

    • Pesticides product

    • Cosmetic product

    • Food additives

    • Feed additives

    • Industrial chemical

      in the Laboratory, in greenhouses or in the field


Type of tests
Type of tests : OECD

  • physico-chemical properties

  • Toxicological studies designed to evaluate human health effects

  • Ecotoxicological studies designed to evaluate environmental effects

  • Ecological studies designed to evaluate environmental chemical fate (transport, biodegradation, and bioaccumulation)

    Ref.No. 6


Why do thailand s laboratory need the glp

Why do Thailand : OECD’s laboratory need the GLP?


Type of tests1
Type of tests : OECD

  • physico-chemical properties

  • Toxicological studies designed to evaluate human health effects

  • Ecotoxicological studies designed to evaluate environmental effects

  • Ecological studies designed to evaluate environmental chemical fate (transport, biodegradation, and bioaccumulation)

    Ref.No. 6



Iso 17025 vs glp

ISO Members : OECD

The same standard for all ISO

Designed for repetitive studies

Description of Quality System in Quality Manual

OECD Members

Different regulations in different countries

Designed for single studies

Description of Quality System in SOPs

ISO 17025 VS GLP


Iso 17025 vs glp1

General statements for responsibilities of personnel : OECD

No specific requirements for storage of records and reports

Very specific responsibilities of personnel

Specific requirements for storage, retention and archiving

ISO 17025 VS GLP


Iso 17025 vs glp2

No study plans required (standardized methods should be used)

Written operating procedures without specific format

Study plan required for each study

SOPs with detailed requirements for format and content

ISO 17025 VS GLP


Iso 17025 vs glp3

Analysis methods must be verified through inter-laboratory test (PT)

Documented complaints procedures

Storage of test samples and data until client accepts results

Validation through inter-laboratory tests not required

In case of problems, only course of law

Storage of test samples according to local regulatory requirements

ISO 17025 VS GLP


Monitoring authority
Monitoring Authority test (PT)

  • The OECD-member

  • Israel

  • South Africa



MAD test (PT)

  • The Mutual Acceptance of Data

  • 1981 : Council Decision on the Mutual Assessment of Data in the Assessment of Chemicals( revised 1997)

  • 1989 : Establishment of national compliance monitoring programmes

  • 1997: non-OECD countries can adhere to the MAD system.


Oecd series on principles of glp and compliance monitoring
OECD Series on Principles of GLP and Compliance Monitoring test (PT)

  • OECD Principles of GLP: No.1

  • Guidance Documents for Compliance Monitoring Authorities : No.2, 3 & 9

  • Consensus Documents : No.5-8, 10 & 13

  • Advisory Documents of the Working Group on GLP : No.11, 12 & 14

    http://www.oecd.org


Conclusion

Conclusion test (PT)


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