PENANG, 4 July 2016 - Universiti Sains Malaysia (USM) has become the first ASEAN university to have laboratory facilities catering to both pre-clinical and clinical studies of world-class standards.

The laboratory facilities known as the Preclinical Translational Unit (PTU) has succeeded in obtaining international accreditation which is the Organisation of Economic Cooperation and Development - Principles of Good Laboratory Practice (OECD-GLP) under the Malaysia National GLP Compliance Programme.

PTU is also the only facility in the country to be accredited as a pre-clinical study facility of GLP standards to conduct toxicology tests on pesticides.

The Director of the Advanced Medical and Dental Institute (IPPT) USM, Dr. Norehan Mokhtar stated that, the significant achievement would provide various benefits for local researchers and also the local industries.

As an example, she said that previously local companies would need to send product samples to be tested in the United Kingdom, India, France and other countries, but now such tests could be conducted at PTU USM.

"The achievement in obtaining the GLP accreditation has been recognised with the full compliance status by the international OECD based in Paris, France which guarantees worldwide acceptance of tests results, hence facilitating the innovations by local researchers and products of local companies to be marketed globally," she said.

Apart from that, for products which require clinical testing on humans, IPPT also has the Clinical Trial Unit (CTU), meant for clinical testing and recognised by the National Pharmaceutical Control Bureau, Ministry of Health Malaysia as one of the facilities under the Clinical Research Malaysia (CRM) that complies to the standards of Good Clinical Practice by the International Conference for Harmonization (ICH-GCP).

She added that, operations of the CTU are supported by IPPT diagnostics laboratory which is the Advanced Diagnostics Laboratory (ADL), recognised by the International Laboratory Accreditation Conference (ILAC) for medical testing of clinical specimens and accorded the ISO 15189 standards by the Department of Standards Malaysia (DSM) under the Malaysian Laboratory Accreditation Scheme.

"The success in establishing the three facilities: PTU, CTU and ADL for pre-clinical and clinical tests is in line with one of the main agenda in establishing IPPT USM, which is to transform the local traditional and complementary medical practices by integrating it into modern medical practices," she said.

Local scientists, clinicians and academicians are welcomed to utilise the pre-clinical animal testing facility at PTU, which is expected to strengthen local academic research and publications, other than fulfilling the needs of local and foreign industries which require GLP standards pre-clinical test reports when applying for product registration from the local and foreign authorities.

Translation: Mazlan Hanafi Basharudin

Text: Marziana Mohamed Alias