The high-tech antibiotic factory (IMP2) of Imexpharm Pharmaceutical Joint Stock Company in Vĩnh Lộc Industrial Park, Ho Chi Minh City, has recently conducted an assessment of the current quality management system (QMS) according to the cGMP standard, a strict pharmaceutical safety assessment standard issued by the US Food and Drug Administration (FDA). This is a strategic step for Imexpharm to invest deeply in product quality in order to gradually access markets with high requirements such as the US market.
Accordingly, IMP2 factory had a 5-day assessment conducted by PhD John R. Wilson, Senior Vice President and Quality Officer of Beaufort, an organization that specializes in consulting pharmaceutical manufacturers on the implementation of cGMP standards.
According to Mr. John, all GMP standards implemented worldwide require manufacturers to comply with minimum standards throughout the entire production process. However, it is important to understand the similarities and differences between non-cGMP and cGMP requirements. Currently, the cGMP standard is a mandatory standard for pharmaceutical manufacturers exporting products to the US market.
PhD John R. Wilson, Senior Vice President and Quality Officer of Beaufort working with Imexpharm Team
cGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. cGMP provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.
The cGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement.
Currently, in Vietnam, there is no pharmaceutical manufacturer that has implemented the cGMP standard of the US FDA announced by the Drug Administrationn of Vietnam. It can be said that Imexpharm's initial steps in implementing cGMP are a testament to the unceasing efforts to invest deeply in quality to ensure safety, reliability, and high efficiency for patients and consumers.
With over 46 years of development history, Imexpharm has always set the goal of improving product quality, upgrade technology, equipping modern technical infrastructure, and optimizing production processes. This direction aims to provide the domestic and international markets with high-quality, reliable, and effective pharmaceutical products to community health care activities.
People's Doctor, Pharmacist Tran Thi Dao, Imexpharm's General Director, shared: "We have always maintained a consistent international standard production system in line with Imexpharm's development direction for over 20 years. This spirit is reflected in the policy of "Improving the quality of life", focusing resources, and investing in a systematic manner in factories that meet EU-GMP and other advanced international standards to provide Vietnamese drugs with high quality and treatment effectiveness at a reasonable price to each patient."
Currently, Imexpharm owns 11 production lines that meet the principles of EU-GMP with 3 clusters of factories that meet the EU-GMP standard, including: Vĩnh Lộc high-tech antibiotic factory (IMP2), Bình Dương, Betalactam antibiotic factory (IMP3), and Bình Dương high-tech factory (IMP4).
Moreover, Imexpharm has also been invested by SK Investment, a member of the SK Group, the second-largest conglomerate in South Korea. With a strong financial foundation and international management experience, SK Investment will help Imexpharm gradually realize its goal of becoming one of the leading pharmaceutical manufacturers in Vietnam.