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Objectives of GLP Section

. Last Updated: 29 June 2022Hits: 162

  1. To conduct and facilitate single dose and repeated dose oral animal toxicology studies in accordance to GLP Principles, OECD-GLP and OECD TG 420, 407 and 408.
  2. To conduct and facilitate single dose and repeated dose animal toxicology studies in accordance to international guidelines such as 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).
  3. To conduct animal toxicology studies in accordance to GLP Principles, OECD-GLP and OECD TG 420 for Malaysian Herbal Monograph.
  4. To provide consultation to inquiring governmental or private bodies on GLP animal toxicology studies.
  5. To conduct general and specialised training for NCRF, IMR personnel and in-house staff.
  6. 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.
  7. To perform maintenance and monitoring of NCRF, IMR facility in accordance to GLP Principles and OECD-GLP certification.  

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