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Akreditasi Sumber Fasiliti Kajian (GLP CP)

Tiada terjemahan ke bahasa melayu.

 

  • OECD Series
    No Document Title Download
    1 OECD Principles of Good Laboratory Practice, 1998 PDF
    2 Guidance for the GLP Monitoring Authorities Procedures for GLP, 1995 PDF
    3 Guidance for the Conduct Laboratory Inspections and Study Audit, 1995 PDF
    4 Quality Assurance and GLP, 1999 [OBSOLETE] PDF
    5 Compliance of Laboratory Suppliers with GLP Principles, 2000 PDF
    6 The Application of the GLP Principles to Field Studies, 1999 PDF
    7 The Application of the GLP Principles to Short Term Studies, 1999 PDF
    8 The Role and Responsibility of the Study Director in GLP Studies, 1999 PDF
    9 Guidance for the Preparation of GLP Inspection Reports, 1995 PDF
    10 The Application of the Principles of GLP to Computerised Systems, 1995 [OBSOLETE] PDF
    11 Advisory document of panel on the GLP: Role and Responsibility of the Sponsor in the Application of the Principles of GLP, 1998 PDF
    12 Advisory document of the Working Group on GLP: Requesting and Carrying Out Inspections and Study Audits in Another Country, 2000 PDF
    13 Consensus document of the Working Group on GLP: The Application of the OECD Principles of GLP to the Organisational and Management of Multi-Sites Studies,2002 PDF
    14 Advisory document of the Working Group on GLP: The Application of the OECD Principles of GLP to In-Vitro Studies, 2004 PDF
    15 Advisory document of the Working Group on GLP: Establishment and Control of Archives that Operate in Compliance with the Principles of GLP, 2007 PDF
    16 Advisory document of the Working Group on GLP: Guidance on the GLP Requirements for Peer Review of Histopathology, 2014 PDF
    17 Advisory document of the Working Group on GLP: Application of GLP Principles to Computerised Systems, 2016 [Notes: This document replaces Consensus Document No. 10] PDF
    18 Supplement 1: Advisory Document on GLP & Cloud Computing (2023) PDF
    19 OECD Position Paper Regarding the Relationship between the OECD Principles of GLP and ISO/IEC 17025, 2016 PDF
    20 Advisory Document of the Working Group on Good Laboratory Practice on the Management Characterisation and Use of Test Items, 2018 PDF
    21 Guidance Document for Receiving Authorities on the Review of the GLP Status of Non-Clinical Safety Studies, 2019 PDF
    22 OECD Position Paper Regarding Possible Influence of Sponsors on Conclusions of GLP Studies, 2020 PDF
    23 Advisory Document of the Working Party on Good Laboratory Practice on GLP Data Integrity, 2021 PDF
    24 Advisory Document of the Working Party on Good Laboratory Practice on Quality Assurance and GLP, 2022
    [Notes: This document replaces Consensus Document No.4]
    PDF
    25 Position Paper on Quality Improvement Tools and GLP, 2022 PDF
  • OECD Publication
    No Document Title Action
    1 Series on the Safety of Manufactured Nanomaterials VIEW
  • Guidance Documents
    No Document Title Download
    1 Malaysian Code of Practice for the Care and Use of Animals for Scientific Purposes PDF
    2 OECD Guidelines for Testing of Chemicals - Full List of test Guidelines (July 2015) PDF
    3 OECD Guidelines for The Testing of Chemicals - Addenda Adopted by Council (July 2015) PDF
    4 OECD Guidance Document on Considerations for Waiving or Bridging of Mammalian Acute Toxicity Tests PDF
  • Circulars
    No Name Document Title Download
    1 GLP CP Circular 1/2021 GLP Compliance Programme: Guidelines for Remote Inspection PDF
  • GLP CP Manual and Appendixes
    No Name Document Title Download
    1 GLP CP MANUAL GLP CP MANUAL Issue 6, 13 March 2023 PDF
    2 Appendix 1 JSM & Accreditation Organisation Chart_13032023 PDF
    3 Appendix 2 GLP unit organisation structure amd 13032023 PDF
    4 Appendix 3 Inspection Process PDF
    5 Appendix 4 GLP-R005 Code of Ethics for inspectors_Issue 2, 21032023 PDF
    6 Appendix 5 GLP-R004 Undertaking of Confidentiality_290709 PDF
    7 Appendix 6 GLP-P016 List of evidence document_amd 290709 PDF
    8 Appendix 7 GLP-R008 Evaluation Report_Issue 2, 130416 PDF
    9 Appendix 8 GLP-R001 Master Register GLP CP_amd 290709 PDF
    10 Appendix 9 GLP-P001 Application form_Issue 3, 21032023 PDF
    11 Appendix 10 GLP-P004 Notification of Pre-Inspection_Issue 3, 21032023 PDF
    12 Appendix 11 GLP-P005 GLP Pre-Inspection report_290709_amdt1_230210 PDF
    13 Appendix 12 GLP-P008 Notification of Inspection_Issue 3, 21032023 PDF
    14 Appendix 13 GLP-P015 GLP Inspection Checklist_290709_amdt1_230210 PDF
    15 Appendix 14 GLP-P009 Test Facility Inspection Report, Issue 3, 21032023 PDF
    16 Appendix 15 GLP-P012 Certificate of compliance to OECD GLP_Issue 2, 21032023 PDF
    17 Appendix 16 GLP-P010  Letter of statement of compliance_Issue 3, 21032023 PDF
    18 Appendix 17 GLP-P013 Inspector's Note_290709 PDF

Note: All publications on sale as listed above can be purchased at:

Department of Standards Malaysia
Level 4-7, Tower 2
Menara Cyber Axis
Jalan Impact, Cyber 6
63000 Cyberjaya
Selangor, MALAYSIA

Tel: 603- 8008 2900
Fax: 603-8008 2901
Email: central[at]jsm[dot]gov[dot]my
Last updated: April 2022

Aras 4-7, Menara 2
Menara Cyber Axis
Jalan Impact, Cyber 6
63000 Cyberjaya
Selangor, MALAYSIA

Tel : +603-8008 2900
Faks : +603-8008 2901
E-mel : central[at]jsm[dot]gov[dot]my

Hari Ini 1150

Semalam 2163

Minggu Ini 3313

Bulan Ini 28484

Jumlah 838883

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