Good Laboratory Practice - UKM Medical Centre

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GLP It is important to clearly differentiate between theformal, regulatory use of term 'good laboratorypractice' as opposed to the general application ofgood practices in scientific investigations
OriginFormal concept of GLP1 st evolved in USA, 1970s as a result of concerns aboutvalidity of preclinical safety data submitted to FDA fornew drug applications1950s -1 970s : 40% toxicology testing were carried out byIndustrial Biotest Laboratories (IBT)1961-1976, FDA imposed requirements for manufacturersto prove drug effectiveness and responsible in determiningif benefits outweigh risks
Page 2 and 3: Role of Laboratories in Medicine Me
Page 4 and 5: Role of laboratories in drugdevelop
Page 6 and 7: Role of laboratories in Clinical Tr
Page 8 and 9: Regulatory Authorities responsible
Page 10 and 11: 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 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 and 62: From stage 3 of development and con
Page 63: Good Practices regulations in drugd

Good Laboratory Practice - UKM Medical Centre

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