Good Laboratory Practice - UKM Medical Centre

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Figure 1 illustrates how so called Good Practicesregulations correlate to the life of a drug, startingfrom basic research and drug discovery on theleft side through preclinical development in themiddle and clinical trials and manufacturing atthe right Figure 1. GLP vs. GCP, GMP and 21 CFFRPart 11
Good Practices regulations in drugdevelopmentillustrates how so called Good Practices regulations correlate to the life of a drug, startingfrom basic research and drug discovery on the left side through preclinical development in themiddle and clinical trials and manufacturing at the right. GLP vs. GCP and GMP
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Role of Laboratories in Medicine Me
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Role of laboratories in drugdevelop
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Role of laboratories in Clinical Tr
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Regulatory Authorities responsible
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Good Laboratory PracticeRequires la
Page 12 and 13: ISOGood Laboratory Practice- Standa
Page 14 and 15: ISO Standards for Accreditation of
Page 16 and 17: Standards for Laboratories involved
Page 18 and 19: GLP It is important to clearly diff
Page 20 and 21: 867 audits of IBT performed by FDA
Page 22 and 23: Establishment of Regulation of Labo
Page 24 and 25: International Harmonisation-OECD Pr
Page 26 and 27: OECD Principle of GLP 1981, Member
Page 28 and 29: Good Laboratory Practice for Labora
Page 30 and 31: Management requirementOrganisation
Page 32 and 33: OECD Principles of GLPfor Preclinic
Page 34 and 35: Fundamental points of GLPGood Labor
Page 36 and 37: Resources Organization & PersonnelS
Page 39 and 40: Equipment : strict programme of val
Page 41 and 42: RulesProtocols The principle steps
Page 43 and 44: RulesStudy Director Concept of SD a
Page 45 and 46: DocumentationRaw Data Results of in
Page 47 and 48: Quality AssuranceQA defined by GLP
Page 49 and 50: Compliance to Standards ISO Accredi
Page 51 and 52: ISO Accreditation Authorities/Bodie
Page 53 and 54: GLP complianceOECD Principles of GL
Page 55 and 56: OECD GLP ComplianceMonitoring Autho
Page 57 and 58: Classical drug development process4
Page 59 and 60: Stage IIIClinical Studies, in human
Page 61: From stage 3 of development and con
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Good Laboratory Practice - UKM Medical Centre

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