5 GLP GLP = Good Laboratory Practice OECD Principles on Good Laboratory PracticeWhat is the OECD?
6 The Organization for Economic Co- operation and Development : OECD Intergovernmental organization30 industrialized countriesMeet to co-ordinate and harmonize policies.Discuss issues of mutual concernWork together to respond to international problems.
7 30 industrialized countries AustraliaAustriaBelgiumCanadaCzech RepublicDenmarkFinlandFranceGermanyGreeceHungaryIcelandIrelandItalyJapanKoreaLuxembourgMexicoNetherlandsNew ZealandPolandPortugalSlovak RepublicSpainSwedenSwitzerlandTurkeyUKUSANorway
8 The purpose of GLPThe 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.
9 Definition of GLPGLP 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.
10 Scope of principle of GLP GLP should be applied to the non-clinical safety testing of test items:Pharmaceutical productPesticides productCosmetic productFood additivesFeed additivesIndustrial chemicalin the Laboratory, in greenhouses or in the field
11 Type of tests physico-chemical properties Toxicological studies designed to evaluate human health effectsEcotoxicological studies designed to evaluate environmental effectsEcological studies designed to evaluate environmental chemical fate (transport, biodegradation, and bioaccumulation)Ref.No. 6
13 Type of tests physico-chemical properties Toxicological studies designed to evaluate human health effectsEcotoxicological studies designed to evaluate environmental effectsEcological studies designed to evaluate environmental chemical fate (transport, biodegradation, and bioaccumulation)Ref.No. 6
15 ISO 17025 VS GLP ISO Members The same standard for all ISO Designed for repetitive studiesDescription of Quality System in Quality ManualOECD MembersDifferent regulations in different countriesDesigned for single studiesDescription of Quality System in SOPs
16 ISO 17025 VS GLP General statements for responsibilities of personnel No specific requirements for storage of records and reportsVery specific responsibilities of personnelSpecific requirements for storage, retention and archiving
17 ISO VS GLPNo study plans required (standardized methods should be used)Written operating procedures without specific formatStudy plan required for each studySOPs with detailed requirements for format and content
18 ISO VS GLPAnalysis methods must be verified through inter-laboratory test (PT)Documented complaints proceduresStorage of test samples and data until client accepts resultsValidation through inter-laboratory tests not requiredIn case of problems, only course of lawStorage of test samples according to local regulatory requirements
19 Monitoring AuthorityThe OECD-memberIsraelSouth Africa
21 MAD 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 programmes1997: non-OECD countries can adhere to the MAD system.
22 OECD Series on Principles of GLP and Compliance Monitoring OECD Principles of GLP: No.1Guidance Documents for Compliance Monitoring Authorities : No.2, 3 & 9Consensus Documents : No.5-8, 10 & 13Advisory Documents of the Working Group on GLP : No.11, 12 & 14