IPharm obtains OECD Good Laboratory Practice compliance certificate
IPharm is proud to be Good Laboratory Practice (GLP) compliant. The OECD GLP certificate was awarded in July 2018 by National Pharmaceutical Regulatory Agency, Ministry of Health. IPharm is now a GLP compliant test facility, which the test results are accepted not only in OECD countries (including European countries, Japan, Korea and USA) but also in countries which adhere to the OECD’s Mutual Acceptance of Data system, i.e. Argentina, Brazil, India, Malaysia, Singapore and South Africa. The certification reduces duplicative testing, saves laboratory costs, promotes work-sharing by countries assessing the same data and removes a potential non-tariff trade barrier.
Malaysia government has been taking effort to promote quality, safety and efficacy in pharmaceuticals. Starting 2018, registration of New Chemical Entity (NCE), biologics, herbal products with high therapeutic claims is required to fulfil GLP requirements in non-clinical safety studies. IPharm’s GLP compliant studies currently cover toxicology for products under category of pharmaceuticals, cosmetics, veterinary drugs and food additives. With the GLP certification, IPharm is capable to provide non-clinical testings that are world-class standard. IPharm will continue to provide cost effective services for companies to meet the regulatory needs for both local and export market in compliance to OECD Principles of GLP, hence the companies will be able to register and export their products globally.
National Institute of Biotechnology Malaysia (NIBM) to lead, coordinate and implement the national biotechnology agenda through activities research, development, innovation and commercialization (RDIC).
IPharm aim to be a Biotechnology’s Centers of Excellence by exploiting megadiversity of Malaysian natural resources for the development of new drugs. IPharm therefore has a mission to conduct world-class R&D; to accelerate the discovery, development and commercialization of pharmaceutical and nutraceutical products.
History of Ipharm
Malaysian Institute of Pharmaceuticals and Nutraceuticals (IPharm) was established on 29th November 2006 under the Ministry of Science, Technology and Innovation in order to spearhead this initiative by delivering world-class R&D to accelerate the discovery, development and commercialization of pharmaceutical and nutraceutical products. IPHARM is a multidisciplinary research instutes aim to be a Biotechnology’s Centers of Excellence by exploiting megadiversity of our natural resources for the development of new drugs. IPharm therefore has a mission to conduct world-class R&D to accelerate the discovery, development and commercialization of pharmaceutical and nutraceutical products.
Tun Dato’ Sri Haji Abdullah bin Haji Ahmad during BioMalaysia Conference on 28 April 2005 at Putrajaya International Conference Centre(PICC. This policy, endorsed by the Malaysian Cabinet on 20 April 2015 emphasises on the development of three core areas of biotechnology, namely the agriculture, healthcare and industry. Under NBP’s Healthcare Biotechnology thrust, the government aspires to get benefit from country’s enviable wealth in natural resources especially in drug discovery and development. Concurrently, the potential of bio-generics market is also recognized as an important area in healthcare biotechnology.
Realizing the challenges in developing the healthcare biotechnology is competitive, the Cabinet endorsed the proposal to establish a centre of excellence. This historical decision marks the birth of the Malaysian Institute of Pharmaceuticals and Nutraceuticals (IPharm). The establishment of the IPharm was approved by the Biotechnology Implementation Council on 7 September 2006 and approved by the Cabinet on 26 November 2006 with two other institutions namely Agro Biotechnology Institute (ABI) and the Malaysian Genome Institute (MGI) under the Ministry of Science, Technology and Innovation. IPharm research facility, previously located within Universiti Sains Malaysia (USM) campus in Pulau Pinang, was relocated to the interim research facility namely [email protected] Complex located at Bukit Jambul, Pulau Pinang in 2008.
Then, in 2011 IPharm has its own building complex strategically located in Halaman Bukit Gambir, Pulau Pinang with area of 10 acres. IPharm was established as a centre of excellence to spearhead the NBP thrusts by delivering world class R&D in order to accelerate the discovery, development and commercialisation of pharmaceutical and nutraceutical products as well as to build the nation’s skilled human resources in Healthcare Biotechnology. In 1 March 2014, all the three institutes established under NBP (IPharm, ABI and MGI) had been transformed and incorporated as National Institutes of Biotechnology Malaysia (NIBM), a not for profit government organisation operating as Company Limited by Guarantee (CLG). This transformation is a move forward for IPharm in ensuring its vision of becoming a Center of Excellence in research and development in healthcare biotechnology become reality. By this transformation, it is hoped that IPharm will be more independent, surge forward with more proactive and dynamic and focus on revenue generation process which include in the production of products and services.
WORKSHOP: BENGKEL PENGHASILAN KOSMETIK 2.0
Time: 09:00 – 17:00
Bengkel Penghasilan Kosmetik (BenKOS 2.0), IPharm 2019 diadakan bertujuan untuk memberi pendedahan kepada masyarakat mengenai langkah dan cara-cara penghasilan kosmetik dari sumber semulajadi dan seterusnya membantu mempromosikan produk- produk buatan tempatan yang selamat dan bermutu. Bengkel ini merupakan kesinambungan kepada Bengkel Penghasilan Kosmetik (BenKos) yang telah diadakan pada tahun 2017. Sasaran utama bengkel adalah pengusaha produk kosmetik tempatan, penyelidik serta individu yang berminat dalam penghasilan produk kosmetik.
WORKSHOP: INTRODUCTION TO ISO 17025:2017
Time: 09:00 – 16:30
This course gives participants the full understanding of ISO/IEC 17025 and the methodology towards developing a Laboratory Quality Management System.