Samsung Biologics Achieves 400 Regulatory Manufacturing Approvals

Samsung Biologics announced on the 26th that it has achieved 400 global regulatory manufacturing approvals, based on its quality competitiveness.

As of November this year, Samsung Biologics has secured a total of 400 manufacturing approvals from numerous regulatory agencies worldwide, including 49 from the U.S. Food and Drug Administration (FDA) and 46 from the European Medicines Agency (EMA). This achievement comes just one year after reaching 300 approvals in October last year, meaning the company has added 100 more approvals in that short period. This rapid accumulation of manufacturing approval track records reflects the company's expansion of production capacity and increase in manufactured products. The company also maintains the industry's highest rate of passing regulatory inspections.

A Samsung Biologics employee is inspecting a bioreactor. Samsung Biologics

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Regulatory manufacturing approval is part of the drug authorization process and indicates that the entire process of manufacturing and quality control for a given pharmaceutical product complies with each country's Good Manufacturing Practice (GMP) standards. It is a mandatory procedure for CDMO (Contract Development and Manufacturing Organization) companies to supply pharmaceuticals to their respective markets. Because dozens of experts and several months of verification are required for each product, it is considered a key indicator for evaluating the quality and operational capabilities of a CDMO company.

The reasons Samsung Biologics has been able to steadily accumulate manufacturing approvals, even from stringent global regulatory agencies in the United States and Europe, include: ▲ development of specialized personnel, ▲ a digital-based quality management system, and ▲ standardization of regulatory response processes.

First, since its establishment in 2011, Samsung Biologics has operated a dedicated inspection team and invested in systematic personnel development. By continuously strengthening analysis of the latest regulatory guidelines, inspection response training, and preparation for client inspections, the company has expanded the number of personnel capable of handling manufacturing approvals from about 70 in 2015 to approximately 500 today.

Additionally, the company has established a digital-based GMP (Good Manufacturing Practice) data management system to integrate and manage production and quality data through electronic documentation and electronic quality systems. By digitizing the vast amounts of data generated during biopharmaceutical production in accordance with GMP regulations and tracking and storing it in real time, the company can respond immediately and accurately to data verification requests from regulatory agencies and clients.

Finally, based on extensive experience with global regulatory inspections, the company has standardized the entire process, from inspection preparation and on-site response to post-inspection corrective and preventive actions. This enables Samsung Biologics to maintain consistent quality standards and response systems, even when product or process characteristics differ, thereby continuously strengthening trust with regulatory agencies.

John Rim, CEO of Samsung Biologics, stated, "Achieving 400 global regulatory manufacturing approvals once again proves our digital-based quality competitiveness and standardized operational capabilities," adding, "We will continue to strengthen our quality management, technological innovation, and regulatory response capabilities to become the most trusted partner for global pharmaceutical companies."

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