Natural Products Quality Control Laboratory (NPQC) has been established under Natural Products Division in FRIM. NPQC has been accredited by Department of Standards Malaysia under Skim Akreditasi Makmal Malaysia (SAMM) which meets the requirements of MS ISO/IEC 17025:2017 ’General requirement for competence of testing and calibration laboratories’ for the testing field of microbiology, chemical and physical. This Malaysian Standards is identical with ISO/IEC 17025:2005 published by the International Organization for Standardization (ISO).
Currently, NPQC offers quality control technical services of; a) microorganism contamination, b) heavy metal analyses, c) weight uniformity and d) disintegration test, for herbal product to herbal industries. The microbial contamination testing comprises a) microbial enumeration which provides the total aerobic microbial count (TAMC) and total combined yeast/ mold count (TYMC), b) specific microorganism of Escherichia coli, Salmonella spp., Staphylococcus aureus, Pseudomonas aeruginosa, Bile tolerant gram negative bacteria and Candida albicans. Elements such as, Cadmium (Cd), Lead (Pb), Mercury (Hg) and Arsenic (As) are being analysed for the heavy metal testing. Both the weight uniformity and disintegration test are for the tablet and capsules product form. The above tests are carried out in accordance with the guidelines outlined under the Drug Registration Guidance Document and Control of Drugs and Cosmetics Regulations 1984. Recently, NPQC has received recognition and endorsement from National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health as a testing laboratory for traditional products. The quality control testing report issued by NPQC, FRIM is recognised and accepted by NPRA. In addition, NPQC is one of the laboratories under the Herbal Product Development Programme which has being awarded the status of BioNexus Partners (BNP) by Bioeconomy Corporation.
The Phytochemistry Programme is one of the programs of the Natural Products Division with ISO 9001:2015 accreditation, which conducts research activities and also provides technical services related to chemical analysis. The analyses offered in the technical services include quality tests, phytochemical screening tests, analyses of the flavonoids, sugar, polysaccharide and saponin content by UV-Vis spectroscopy, FTIR spectroscopic analyses, 1D and 2D NMR spectroscopic analyses, qualitative profiling and quantitative HPLC and LC-MS, analysis of the eurycomanone content of raw materials and tongkat ali products using UPLC, and general and qualitative HPTLC profiling. The laboratory in the Phytochemistry Programme has also been accredited by the Department of Standards Malaysia under the Skim Akreditasi Makmal Malaysia (SAMM), which meets the requirements of MS ISO/IEC 17025:2017 for “Identification of tongkat ali root by HPLC analysis”. The analytical method was developed through extensive research studies on more than 100 samples of tongkat ali roots. This analysis is offered to the herbal industry or interested parties to ensure that the samples used in their products are authentic and genuine.
The Centre for Authentication of Herbal Raw Material (CAHRM), FRIM serves to provide Certificates of Analysis (COA) for the authentication of herbal raw materials with the ultimate goal of empowering the Malaysian herbal industry by improving the quality, safety and efficacy of manufactured products. The various laboratories involved in the FHMAC have received the status of BioNexus Partners (BNP) Laboratories from the Bioeconomy Corporation. The aim of the centre is to ensure the safety and effectiveness of the use of herbs, to provide a platform for the scientific development of guidelines for quality assurance, to promote responsible and sustainable commerce of herbal products within the industry and trade of herbs, to ensure the competitiveness of domestic herbs in the world market, to become a reference and training centre, and also conservation centre of herbal species.
FRIM has been recognised as a Centre of Excellence in forest biotechnology and the development of natural products, with two biotechnology and four natural product R&D laboratories being awarded with BioNexus Partner (BNP) status. The Tissue Culture Laboratory and Genetics Laboratory were granted BNP status in 2008, which offers services on mass propagation of planting materials and tests on identification and authentication of plants through DNA technology, respectively. The Phytochemistry Laboratory obtained the BNP status in 2009, while the Herbal Product Development Laboratory, Pharmacognosy Laboratory and Herbal Technology Centre (HTC) in 2011. The BNP laboratories offer a collaborative network of key facilities, services and expertise with other universities, research institutes, technology parks, incubation centres and government-linked companies (GLC) with the aim of empowering our local biotechnology and herbal industry. As a part of this programme, FRIM has performed testing services on more than 4,700 samples from at least 400 companies/clients. Three of these laboratories are accredited under the MS ISO/IEC 17025 scheme, of which the Natural Product Quality Control Laboratory (NPQC) has been a panel laboratory for the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health since 2016. The quality control testing report produced by NPQC laboratory can verify the quality and safety of products and directly expedite the process of product registration with NPRA. At the same time, HTC has also obtained Good Manufacturing Practices (GMP) and Halal certification to improve the quality of traditional herbal products. In addition, the Best BNP for AgBiotech Award and Most Collaborative BNP Award were awarded to two BNP laboratories in 2013 and 2015, respectively. The Bioeconomy Corporation has continuously extended the BNP status for the six BNP laboratories in view of their outstanding performances. Equipped with state-of-the-art research facilities and expertise, FRIM welcomes partnerships with the forest biotechnology and herbal industries to improve the quality of planting materials and herbal products, enhance business competitiveness and expand into international markets.