CGBio, a company specializing in bio regenerative medicine, (representative director Hyun Seung Yu) announced on the 13th that its smart factory S-Campus has recently received the Brazil Good Manufacturing Practice(BGMP) certification from the Brazilian Health Regulatory Agency (hereinafter referred to as the “ANVISA”).
The certification is expected to accelerate the company’s advance into the South American market with its range of filler products, such as hyaluronic acid (HA) filler GISELLELIGNE and calcum (CaHA) filler Facetem.
S-Campus is a large-scale production center built in 2019, spanning one basement level and two above-ground levels with a total floor area of 4,316 m2 (approx. 1,305 pyeong). The facility was designed and built to meet the manufacturing and quality standards of major countries.
It has its infrastructure facilities such as air-conditioning systems (HVAC system) and injection water manufacturing equipment (WFI generation system) on the basement level, and the manufacturing and packaging facilities for filler products on the first above-ground level, and the production facilities for human tissue, synthetic bone, stent, quasi drugs and cosmetics on the second above-ground level. Accordingly, the production center can manufacture and produce a range of products such as human tissue, cosmetics and quasi drugs, not to mention class 3 and 4 medical devices.
In addition, it is a cutting-edge smart factory using a building management system (BMS) that can run all facilities 24 hours and back up all data automatically, reducing human error and defect rate for a higher production volume. It is also equipped with an intelligent CCTV system that can detect and automatically capture footages of any movement inside the building, allowing intensive management for prevention of fire and safety accident.
With such excellence, S-Campus obtained the KGMP certification from the Ministry of Food and Drug Administration in 2019, followed by medical device manufacturing certification and ISO 13485 (medical device quality management system) certification in 2020. Obtaining the BGMP certification from ANVISA is particularly significant as it is known to be one of the most stringent and fastidious certifications among South American countries.
The recent acquisition of BGMP certification is expected to accelerate the advance of filler GISELLELIGNE and Facetem into other South American countries, as well as Brazil, the largest market in South America.
Representative director Hyun Seung Yu of CGBio said, “The acquisition of BGMP certification is expected to accelerate the advance of our products such as fillers into South America and at the same time, has proven that our S-Campus is truly a global production base that meets the global manufacturing standards, ” adding “We will keep dedicating our best efforts to provide quality products all around world.”
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