Good Laboratory Practice - UKM Medical Centre

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Role of Laboratories in Medicine Medical Testing Laboratorypatient careclinical drug trial Research Laboratorydiscovery & development of newdrugs/therapyfundamental research/mechanisms of diseases Manufacturingpost clinical trials, bulkdrugs, cell-based therapy, plasma products, medicaldevice
Drug Development Process Stage I Stage 2 Stage 3 Stage 4Discovery Non-clinical Clinical Post-approvalTime line approximately 10 yrsManufacturing
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 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 and 62:
From stage 3 of development and con
Page 63:
Good Practices regulations in drugd
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Good Laboratory Practice - UKM Medical Centre

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