• Share
  • Email
  • Embed
  • Like
  • Save
  • Private Content
Glp & quality assurance
 

Glp & quality assurance

on

  • 275 views

 

Statistics

Views

Total Views
275
Views on SlideShare
275
Embed Views
0

Actions

Likes
0
Downloads
12
Comments
0

0 Embeds 0

No embeds

Accessibility

Upload Details

Uploaded via as Microsoft PowerPoint

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment

    Glp & quality assurance Glp & quality assurance Presentation Transcript

    • GLP & Quality AssuranceGLP & Quality Assurance ByBy SUNILBOREDSUNILBORED DYDY
    • Relative between REACH and GLPRelative between REACH and GLP  Safety Data Sheet (SDS)Safety Data Sheet (SDS) – physico-chemical properties : 20 itemsphysico-chemical properties : 20 items – Toxicological studies : 41 itemsToxicological studies : 41 items – Ecotoxicological studies : 10 itemsEcotoxicological studies : 10 items
    • OUTLINEOUTLINE  What is the GLP?What is the GLP?  Why do Thailand’s laboratory need the GLP?Why do Thailand’s laboratory need the GLP?  What is a difference between GLP & ISO 17025?What is a difference between GLP & ISO 17025?  What is the MAD program?What is the MAD program?
    • What is the GLP?What is the GLP?
    •  GLP =GLP = GGoodood LLaboratoryaboratory PPracticeractice  OECD Principles on Good Laboratory PracticeOECD Principles on Good Laboratory Practice  What is the OECD?What is the OECD? GLPGLP
    • The Organization for Economic Co- operation andThe Organization for Economic Co- operation and Development : OECDDevelopment : OECD  Intergovernmental organizationIntergovernmental organization  30 industrialized countries30 industrialized countries  Meet to co-ordinate and harmonize policies.Meet to co-ordinate and harmonize policies.  Discuss issues of mutual concernDiscuss issues of mutual concern  Work together to respond to international problems.Work together to respond to international problems.
    • 30 industrialized countries30 industrialized countries 1.1. AustraliaAustralia 2.2. AustriaAustria 3.3. BelgiumBelgium 4.4. CanadaCanada 5.5. Czech RepublicCzech Republic 6.6. DenmarkDenmark 7.7. FinlandFinland 8.8. FranceFrance 9.9. GermanyGermany 10.10. GreeceGreece 21.21. PolandPoland 22.22. PortugalPortugal 23.23. Slovak RepublicSlovak Republic 24.24. SpainSpain 25.25. SwedenSweden 26.26. SwitzerlandSwitzerland 27.27. TurkeyTurkey 28.28. UKUK 29.29. USAUSA 30.30. NorwayNorway 11.11. HungaryHungary 12.12. IcelandIceland 13.13. IrelandIreland 14.14. ItalyItaly 15.15. JapanJapan 16.16. KoreaKorea 17.17. LuxembourgLuxembourg 18.18. MexicoMexico 19.19. NetherlandsNetherlands 20.20. New ZealandNew Zealand
    • The purpose of GLPThe purpose of GLP  The principle of Good laboratory practice (GLP) : toThe principle of Good laboratory practice (GLP) : to promote the development of quality and validity ofpromote the development of quality and validity of test data used for determining the safety of chemicalstest data used for determining the safety of chemicals and chemicals product.and chemicals product.
    • Definition of GLPDefinition of GLP  GLP is a quality system concerned with theGLP is a quality system concerned with the organizational process and the conditions underorganizational process and the conditions under which non-clinical health and environmental safetywhich non-clinical health and environmental safety studies arestudies are planned, performed, monitored, recorded,planned, performed, monitored, recorded, archived and reportedarchived and reported..
    • Scope of principle of GLPScope of principle of GLP  GLP should be applied to the non-clinical safety testing ofGLP should be applied to the non-clinical safety testing of test items:test items:  Pharmaceutical productPharmaceutical product  Pesticides productPesticides product  Cosmetic productCosmetic product  Food additivesFood additives  Feed additivesFeed additives  Industrial chemicalIndustrial chemical in the Laboratory, in greenhouses or in the fieldin the Laboratory, in greenhouses or in the field
    • Type of testsType of tests  physico-chemical propertiesphysico-chemical properties  Toxicological studies designed to evaluate human healthToxicological studies designed to evaluate human health effectseffects  Ecotoxicological studies designed to evaluate environmentalEcotoxicological studies designed to evaluate environmental effectseffects  Ecological studies designed to evaluate environmentalEcological studies designed to evaluate environmental chemical fate (transport, biodegradation, and bioaccumulation)chemical fate (transport, biodegradation, and bioaccumulation)
    • Why do Thailand’s laboratory need theWhy do Thailand’s laboratory need the GLP?GLP?
    • Type of testsType of tests  physico-chemical propertiesphysico-chemical properties  Toxicological studies designed to evaluate human healthToxicological studies designed to evaluate human health effectseffects  Ecotoxicological studies designed to evaluate environmentalEcotoxicological studies designed to evaluate environmental effectseffects  Ecological studies designed to evaluate environmentalEcological studies designed to evaluate environmental chemical fate (transport, biodegradation, and bioaccumulation)chemical fate (transport, biodegradation, and bioaccumulation)
    • What is a difference between GLP & ISOWhat is a difference between GLP & ISO 17025?17025?
    • ISO 17025ISO 17025 VSVS GLPGLP 1.1. ISO MembersISO Members 2.2. The same standard for allThe same standard for all ISOISO 3.3. Designed for repetitiveDesigned for repetitive studiesstudies 4.4. Description of QualityDescription of Quality System in Quality ManualSystem in Quality Manual 1.1. OECD MembersOECD Members 2.2. Different regulations inDifferent regulations in different countriesdifferent countries 3.3. Designed for single studiesDesigned for single studies 4.4. Description of QualityDescription of Quality System in SOPsSystem in SOPs
    • ISO 17025ISO 17025 VSVS GLPGLP 5.5. General statements forGeneral statements for responsibilities ofresponsibilities of personnelpersonnel 6.6. No specific requirementsNo specific requirements for storage of records andfor storage of records and reportsreports 7.7. No study plans requiredNo study plans required (standardized methods(standardized methods should be used)should be used) 8.8. Written operatingWritten operating procedures withoutprocedures without specific formatspecific format 5.5. Very specificVery specific responsibilities ofresponsibilities of personnelpersonnel 6.6. Specific requirements forSpecific requirements for storage, retention andstorage, retention and archivingarchiving 7.7. Study plan required forStudy plan required for each studyeach study 8.8. SOPs with detailedSOPs with detailed requirements for formatrequirements for format and contentand content
    • ISO 17025ISO 17025 VSVS GLPGLP 9.9. Analysis methodsAnalysis methods must be verifiedmust be verified through inter-through inter- laboratory test (PT)laboratory test (PT) 10.10. DocumentedDocumented complaintscomplaints proceduresprocedures 11.11. Storage of testStorage of test samples and datasamples and data until client acceptsuntil client accepts resultsresults 9.9. Validation throughValidation through inter-laboratory testsinter-laboratory tests not requirednot required 10.10. In case of problems,In case of problems, only course of lawonly course of law 11.11. Storage of testStorage of test samples accordingsamples according to local regulatoryto local regulatory requirementsrequirements
    • Monitoring AuthorityMonitoring Authority  The OECD-memberThe OECD-member  IsraelIsrael  South AfricaSouth Africa
    • What is the MAD program?What is the MAD program?
    • MADMAD  The Mutual Acceptance of DataThe Mutual Acceptance of Data  1981 : Council Decision on the Mutual Assessment of Data in1981 : Council Decision on the Mutual Assessment of Data in the Assessment of Chemicals( revised 1997)the Assessment of Chemicals( revised 1997)  1989 : Establishment of national compliance monitoring1989 : Establishment of national compliance monitoring programmesprogrammes  1997: non-OECD countries can adhere to the MAD system.1997: non-OECD countries can adhere to the MAD system.
    • OECD Series on Principles of GLP and ComplianceOECD Series on Principles of GLP and Compliance MonitoringMonitoring  OECD Principles of GLP: No.1OECD Principles of GLP: No.1  Guidance Documents for Compliance Monitoring Authorities :Guidance Documents for Compliance Monitoring Authorities : No.2, 3 & 9No.2, 3 & 9  Consensus Documents : No.5-8, 10 & 13Consensus Documents : No.5-8, 10 & 13  Advisory Documents of the Working Group on GLP : No.11,Advisory Documents of the Working Group on GLP : No.11, 12 & 1412 & 14 http://www.oecd.orghttp://www.oecd.org
    • THANK YOUTHANK YOU