OECD-GLP-MAD

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Malaysian Compliance Monitoring Authority for OECD GLP

The primary objective of the OECD Principles of Good Laboratory Practice (GLP) is to ensure the generation of high quality and reliable test data related to the safety of industrial chemical substances and preparations in the framework of harmonising testing procedures for the Mutual Acceptance of Data (MAD).

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    A list of useful OECD GLP documents for your quick reference 

Documents
 OECD Principles of Good Laboratory Practice 1988
 Guidance for the GLP Monitoring Authorities Procedures for GLP, 1995
 Guidance for the Conduct Laboratory Inspections and Study Audit, 1995
 Quality Assurance and GLP, 1999
 Compliance of Laboratory Suppliers with GLP Principles, 2000
 The Application of the GLP Principles to Field Studies, 1999
 The Application of the GLP Principles to Short Term Studies, 1999
 The Role and Responsibility of the Study Director in GLP Studies, 1999
 Guidance for the Preparation of GLP Inspection Reports, 1995
 The Application of the Principles of GLP to Computerised Systems, 1995
 Advisory document of panel on the GLP : Role and Responsibility of the Sponsor in the Application of the Principles of GLP, 1998
 Advisory document of the Working Group on GLP : Requesting and Carrying Out Inspections and Study Audits in Another Country,  2000
 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
 Advisory document of the Working Group on GLP : The Application of the OECD Principles of GLP to In-Vitro Studies, 2004
 Advisory document of the Working Group on GLP : Establishment and Control of Archives that Operate in Compliance with the  Principles of GLP,  2007

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
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