Good Laboratory Practice - UKM Medical Centre

More documents

Recommendations

Info

ISO Standards for Accreditation of LaboratoriesFor Competence of Testing and Calibration Laboratories ISO/IEC Guide 25 (1990) ISO/IEC 17025 (1999) new standards which meets those ofISO 9001 and 9002 covering both technical and managerialrequirements ISO/IEC 15189 (2002)- expanded to include requirements for quality andcompetence of Medical Laboratories
Standards for Laboratory involved inClinical Studies Accreditation to ISO 17025- requirements for the competence of testing andcalibration laboratories Accreditation to ISO/IEC 15189 (2002)- requirements for quality and competence of MedicalTesting Laboratories
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 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

Good Laboratory Practice - UKM Medical Centre

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?