Samsung Biologics hits 400 global 메이저 바카라사이트 유니88벳 manufacturing approvals, driven by quality excellence

[by Kang, In Hyo] Samsung Biologics disclosed on November 26 that it has reached 400 ‘global regulatory agency manufacturing approvals,’ underscoring the company’s quality competitiveness.

As of November, Samsung Biologics has secured a total of 400 cumulative manufacturing approvals issued by numerous global 메이저 바카라사이트 유니88벳 agencies, including 49 from the U.S. Food and Drug Administration (FDA) and 46 from the European Medicines Agency (EMA).

This milestone reflects a net gain of 100 approvals within a single year following the achievement of 300 approvals in October 2024. Samsung Biologics characterized this pace as evidence of the markedly accelerated accumulation of 메이저 바카라사이트 유니88벳 manufacturing approvals, attributing the improvement to expanded production capacity and increased product offerings. The company further stated that its 메이저 바카라사이트 유니88벳 inspection pass rate continues to rank among the highest in the industry.

메이저 바카라사이트 유니88벳 manufacturing approval constitutes a component of the pharmaceutical authorization process, indicating that production complies with the Good Manufacturing Practice (GMP) standards of the respective country. For pharmaceuticals manufactured by Contract Development and Manufacturing Organizations (CDMOs), this approval is an obligatory requirement for market supply in the corresponding jurisdiction. Because each product undergoes an extensive validation process supported by dozens of specialized personnel and several months of verification, 메이저 바카라사이트 유니88벳 manufacturing approval serves as a key indicator of a CDMO's quality and operational capabilities.

Samsung Biologics' capacity to consistently obtain manufacturing approvals, even under stringent inspections by global 메이저 바카라사이트 유니88벳 authorities in the United States and Europe, has been attributed to several key factors. These include the cultivation of a dedicated workforce, the establishment of a digital-based quality management system, and the standardization of 메이저 바카라사이트 유니88벳 response processes.

Since its establishment in 2011, Samsung Biologics has invested in systematic human resource development and has operated a dedicated inspection team. Through the continuous improvement of internal analysis of the latest 메이저 바카라사이트 유니88벳 guidelines, training for inspection response execution, and preparation support for customer-facing inspections, the company has grown its 메이저 바카라사이트 유니88벳 manufacturing approval workforce from approximately 70 personnel in 2015 to approximately 500 personnel today.

In addition, the company has implemented a digital-based GMP data management system that consolidates manufacturing and quality datasets into electronic documentation and an electronic quality system. Through the digitization of the vast amount of data produced throughout the biopharmaceutical production process, combined with real-time GMP-compliant tracking and archival, Samsung Biologics has positioned itself to deliver timely and precise responses to data verification requests issued by 메이저 바카라사이트 유니88벳 authorities and customers.

Finally, drawing on its extensive experience with global 메이저 바카라사이트 유니88벳 inspections, the company standardized the full inspection lifecycle, encompassing preparation, on-site response, and post-inspection corrective and preventive measures. This standardization enables the company to sustain consistent quality standards and 메이저 바카라사이트 유니88벳 response systems, even when product or process characteristics change, thereby contributing to the ongoing strengthening of 메이저 바카라사이트 유니88벳 trust.

"Reaching 400 manufacturing approvals from global regulatory agencies further validates our digital-based quality competitiveness and standardized operational execution capacity. We will persist in advancing quality management, technological innovation, and regulatory response capabilities, with the goal of remaining the most trusted development and manufacturing partner for global pharmaceutical companies," said John Rim, CEO of Samsung Biologics.