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Objectives of GLP Section

. Last Updated: 08 November 2024Hits: 1954

  1. To facilitate the conduct of single-dose and repeated-dose animal toxicology studies in accordance with 10 OECD-GLP Principles and OECD Testing Guidelines. 

 

  1. To facilitate the conduct of single-dose and repeated-dose animal toxicology studies in accordance with international guidelines such as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), U.S. Food & Drug Administration (FDA), and European Medicines Agency (EMA).

 

  1. To conduct animal toxicology studies in accordance to 10 OECD-GLP Principles, OECD Testing Guidelines for Malaysian Herbal Monograph.

 

  1. To provide consultation to inquiring governmental or private bodies on GLP animal toxicology studies.

 

  1. To conduct general and specialised training for NCRF, IMR personnel and in-house staff.

 

  1. To engage and coordinate with the Compliance Monitoring Authority (CMA) of National Pharmaceutical Regulatory Agency (NPRA) or surveillance inspections, test facility visits, meetings, training and many more.

 

  1. To perform maintenance and monitoring of NCRF, IMR facility in accordance to GLP Principles and OECD-GLP certification. 

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