Samsung Biologics said on the 26th that it has achieved 400 manufacturing approvals from global regulators.
As of this month, the company secured a total of 400 manufacturing approvals from regulators around the world, including 49 from the U.S. Food and Drug Administration (FDA) and 46 from the European Medicines Agency (EMA). It obtained 100 more in one year after surpassing 300 in Oct. last year.
A Samsung Biologics official said, "Manufacturing approvals are accumulating quickly as production capacity expands and the number of manufactured products increases," and noted, "The inspection pass rate also remains at the industry's highest level."
Manufacturing approval is a key step in the drug authorization process and means that production facilities and manufacturing and quality control processes comply with each country's good manufacturing practice (GMP) standards. It is a procedure that corporations engaged in contract development and manufacturing (CDMO) must pass to supply drugs they produce to the country in question, with dozens of specialists participating in verification over a long period for each product. Because of this, the number of manufacturing approvals is regarded as a key metric for assessing the quality and operational capabilities of CDMO corporations.
The company cited ▲ development of specialists ▲ a digital, quality management system ▲ and standardization of regulatory responses as reasons behind the rapid increase in approvals.
Samsung Biologics has operated an "inspection task force" since shortly after its founding in 2011 to systematically develop regulatory response personnel. By strengthening analysis of the latest regulatory guidelines and training for inspection responses, it expanded related staff from about 70 in 2015 to 500 now.
It also established a digital, GMP management system that integrates production and quality data through electronic document and electronic quality systems. By tracking and storing the vast data generated during biopharmaceutical manufacturing in real time, the company can respond immediately to data verification requests from regulators and clients.
In addition, drawing on experience with inspections by regulators in various countries, the company standardized the entire process from inspection preparation to on-site response to corrective and preventive actions. Through this, it has maintained consistent quality and response systems even when products or processes change, bolstering trust from global regulators.
John Rim, CEO of Samsung Biologics, said, "The 400 manufacturing approvals again prove our digital, quality competitiveness and standardized operational capabilities," and added, "We will continue to strengthen quality management and technological innovation to become the most trusted partner of global pharmaceutical companies."