Good Laboratory Practice - UKM Medical Centre

More documents

Recommendations

Info

Handling and disposal of waste should be carried out insuch a manner so as not to influence the integrity of thestudy in progress and consistent with regulatoryrequirementsappropriate collection, storage, disposal facilities,decontamination, transportation and destructionprocedures Archive facilitites should be provided for storage andretrieval of raw data, samples and specimens. Access toarchive should be limited to personnel authorized bymanagement
RulesProtocols The principle steps of studies have to be described in aStudy Protocol or Study Plan The Protocol has to be adopted by the Study Directorthrough dated signature before study starts and alterationsto the study design cannot be made unless by formalamendment procedures.
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 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: Equipment : strict programme of val
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?