Established in 2018 under the Herbal Medicine Research Centre (HMRC), the GLP Section serves as the core unit supporting the implementation and conduct of Good Laboratory Practice (GLP) studies at the Non-Clinical Research Facility (NCRF), Institute for Medical Research (IMR). Located in Jalan Pahang, Kuala Lumpur, the NCRF has been accredited as an Organisation for Economic Co-operation and Development (OECD) GLP-compliant facility since 2014. The Section plays a pivotal role in upholding the OECD-GLP 10 Principles, covering key areas such as Test Facility Management, Study Director oversight, Study Personnel competency, and Data Archiving, ensuring the highest standards of scientific integrity and regulatory compliance.

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

• 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).

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

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

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

• 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.

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

The GLP Section, in collaboration with NCRF IMR, specialises in in vivo toxicology studies on rodents to evaluate product safety for regulatory registration both locally and internationally.

Our GLP-trained team conducts general toxicity studies in full compliance with OECD Test Guidelines (TG), including:

• TG 420: Single-dose (acute) oral toxicity study

• TG 407: Repeated-dose 28-day (sub-acute) oral toxicity study

• TG 408: Repeated-dose 90-day (sub-chronic) oral toxicity study

These studies form the foundation for safety assessments of new products prior to global registration and marketing.

As an OECD-GLP accredited facility, we are committed to delivering reliable, high-quality non-clinical data supported by state-of-the-art technology and a skilled scientific team.

Our services encompass a full spectrum of GLP-compliant toxicological evaluations, including:

• General and detailed clinical observations

• Monitoring of food and water intake

• Body weight measurement

• Ophthalmological examination

• Clinical biochemistry and haematological analysis

• Functional observational assessments

• Necropsy and gross pathology

• Organ weighing

• Histopathology slide preparation

• Single dose (acute) oral toxicity studies on rodents according to OECD TG 420.

• Repeated dose 28-day (sub-acute) oral toxicity studies on rodents according to OECD TG 407.

• Repeated dose 90-day (sub-chronic) oral toxicity studies on rodents according to OECD TG 408.

• Animal toxicology studies according to international guidelines -ICH, FDA, and EMA.

• Single dose (acute) oral toxicity studies on rats according to OECD TG 420 and 10 OECD-GLP Principles for Malaysian Herbal Monograph.

• Provide consultation and organise meetings with potential sponsors such as ministries, universities, pharmaceutical companies, and industries to conduct animal toxicology studies.

• Organise GLP Refresher Course yearly for NCRF Personnel and other general GLP courses for newly appointed and current NCRF personnel.

• Organise specialised animal training and competency evaluations -blood sampling, necropsy, histopathology, ophthalmological and more.

• Organise specialised GLP personnel role training and competency evaluations -Study Director, Quality Assurance, Study Personnel and more.

• Coordinate and facilitate surveillance inspections by CMA for the renewal of OECD-GLP certification of NCRF, IMR every 2 years.

• Coordinate and facilitate visits from local and international GLP facilities.