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 17025:2005 ’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.
MBIO is one of the laboratories under the Natural Products Division (BHS) that offers technical services (bioactivity test) to the herbal industry. Among bioactivity testing services offered are anti-oxidant (Xanthine/Xanthine Oxidase Superoxide Scavenging, DPPH Radical Scavenging Assay, Tyrosinase Inhibitory Assay, Hydrophilic Oxygen Radical Absorbance Capacity (H-ORAC), Elastase Inhibitory Assay, & Total Phenolic Determination), anti-inflammatory (Hyaluronidase Assay System, Lipoxygenase Assay System, & Xanthine Oxidase Assay System), anti-diabetic (a-Amylase & a-Glucosidase Inhibition Assays), cytotoxicity (Vero Cell Line (kidney), WRL-68 (liver) & 3T3 (fibroblast) and acute toxicity.
Hydrophilic Oxygen Radical Absorbance Capacity (H-ORAC) test is offered under MBIO accredited IEC / MS ISO 17025 status under the Laboratory Accreditation Scheme of Malaysia (SAMM) in the year 2015. The ORAC test management system carried out is credible, competent and fulfilled the international standard. In addition, MBIO has also being awarded the status of BioNexus Partners (BNP) by Bioeconomy Corporation.
The Herbal Raw Material Authentication Centre, (FHMAC) FRIM serves to provide certification of authentication (COA) for herbal raw materials, with the ultimate aim to strengthen the Malaysian herbal industry by enhancing the quality, safety and efficacy of the products produced. The various laboratories involved in FHMAC have been awarded with BioNexus Partners status by Bioeconomy Corporation. The centre aims to guarantee the safety and efficacy in the use of herbs, provide a platform for scientific development in the quality assurance guidelines, promote responsibilities in herbal trade and industry, enhance competitiveness of local herbals in the global market, be a source of reference and training as well as centre of conservation for herbal species.
FRIM has been recognised as a Centre of Excellence in Natural Products Development and four laboratories in FRIM have been accredited with the BioNexus Partners status. The Phytochemistry Laboratory was accorded the status on 12 October 2009, followed by the Herbal Product Development Laboratory, Pharmacognosy Laboratory and Herbal Technology Centre (HTC) on 5 January 2011.BNP programme provides a network for cooperation between these laboratories and other higher learning institutes, research institutes,technology park, incubation centres and government-linked companies (GLCs)in efforts to empower the herbal industry. Through this programme, FRIMhas conducted testing services on 3,484 samples from 313companies/clients. In addition, three of these laboratories have been accredited under theISO/IEC17025scheme, of which the Natural Product Quality Control Laboratory (NPQC) has also been recognised as apanellab for the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health from 2016 to2021. The product quality control test results produced by NPQC labs can verify the quality and safety of the products and directly expedite the process of product registration at NPRA. Meanwhile,HTC has also gained the status of Good Manufacturing Practice (GMP)and Halal Certification to help improve the quality of traditional herbal products. In addition, two awards were awarded to two BNP labs namely Best BNP for AgBiotech Award and Most Collaborative BNP Award in 2013 and 2015 respectively.Based on the performance by each laboratory, Bioeconomy Corporation has renewed the BNP status for all the laboratories up tothe year of 2021. FRIM is prepared to work with any party in enhancing the quality of herbal products, their competitiveness and ability to penetrate the local and international markets.