Press Releases
Propelling Quality Through Innovation & Accumulated Expertise
Upon completion of the world’s largest manufacturing plant—Plant 4—Samsung Biologics’ Bio Campus I has allowed the company to achieve the largest total capacity within the shortest time in the industry, while providing a wider breadth of solutions for our clients. The company has partnered with over 100 global pharma companies to manufacture biopharmaceuticals, with utmost priority on patient safety and quality.
In this article, we explore Samsung Biologics’ quality competitiveness and expertise built over the years and how this has become the backbone of the company’s successful expansion and rapid growth.
Yunjin Hong, Senior Director and Head of Quality Assurance, credits the company’s quality competitiveness to its robust and extensive quality management system.
Throughout its 12 years of operation, Samsung Biologics has been inspected and audited over 200 times by global and local regulatory bodies as well as by clients. During that time, the company has fine-tuned its own quality system and processes to meet strict global quality regulations and practices.
“Samsung Biologics has implemented digitalization features for better quality management by leveraging IT expertise to deploy a ‘person-in-plant’ concept, giving clients direct access to records related to their products,” said Hong. “Our clients have really been satisfied with our system, with access to necessary documents and records on demand.”
Samsung Biologics launched an integrated electronic document and quality management system, which allows authorized employees to manage quality records in a single platform, ultimately improving CGMP (current Good Manufacturing Practice) recording tracking, documentation, and assessment. The system also gives external clients transparent, real-time, and direct access to request, review, and approve documents and records related to their products.
Samsung Biologics’ quality competitiveness can also be attributed to its rapid expansion, according to Hong.
“With each plant we’ve built, we continuously acquire more know-how and opportunity to adapt new regulations and standards,” said Hong. “This allows us to provide the highest quality to our clients, while maintaining the most current compliance requirements.”
Furthermore, one team oversees the entire quality process across Plants 1-4, enabling unified and consistent management. Thanks to this, it has been able to efficiently implement a quality system and minimize potential risks, even in new plants.
Samsung Biologics is also championing an FDA initiative known as Quality Management Maturity, which is intended to raise awareness – at all levels of management in the pharma industry – about how to best achieve quality objectives. The goal of this initiative is for drug manufacturers to have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement.
According to Hong, Samsung Biologics’ quality system has advanced immensely since its foundation. It allows them to take a proactive approach by identifying potential deviations in advance. Corrective and preventive actions can be designed pre-emptively, rather than taking measures after an issue is detected.
She added that the company is also trying to promote a quality mindset across the entire management.
“We’re planning to launch training programs for not just quality-related personnel, but the company as whole. This way, we can all understand the need for continuous quality improve and take initiative,” said Hong. “It’s about making GMP a culture.”
Samsung Biologics will continue to advance its quality system and accelerate the development and manufacturing of high-quality, life-saving treatments for patients around the world. Plant 4 will be fully operational soon, and there will be additional plants to come.
The company is committed to using expertise and digital innovation to make a positive impact on the healthcare industry.
Related Contents
Samsung BIO Insight Samsung Biologics’ Super Plant 4, How the world’s largest biomanufacturing plant will drive clients’ success
Webinars EQUIS: A Platform for Digital Transformation at Samsung Biologics
Upon completion of the world’s largest manufacturing plant—Plant 4—SamsungBiologics’ Bio Campus I has allowed the company to achieve the largest total capacity within the shortesttime in the industry, while providing a wider breadth of solutions for our clients. The company haspartnered with over 100 global pharma companies to manufacture biopharmaceuticals, with utmost priority onpatient safety and quality.
In this article, we explore Samsung Biologics’ qualitycompetitiveness and expertise built over the years and how this has become the backbone of the company’ssuccessful expansion and rapid growth.
Yunjin Hong, Senior Director and Head of QualityAssurance, credits the company’s quality competitiveness to its robust and extensive quality managementsystem.
Throughout its 12 years of operation, Samsung Biologicshas been inspected and audited over 200 times by global and local regulatory bodies as well as by clients.During that time, the company has fine-tuned its own quality system and processes to meet strict global qualityregulations and practices.
“Samsung Biologics has implemented digitalizationfeatures for better quality management by leveraging IT expertise to deploy a ‘person-in-plant’ concept, givingclients direct access to records related to their products,” said Hong. “Our clients have really been satisfiedwith our system, with access to necessary documents and records on demand.”
Samsung Biologics launched an integrated electronicdocument and quality management system, which allows authorized employees to manage quality records in a singleplatform, ultimately improving CGMP (current Good Manufacturing Practice) recording tracking, documentation, andassessment. The system also gives external clients transparent, real-time, and direct access to request, review,and approve documents and records related to their products.
Samsung Biologics’ quality competitiveness can also beattributed to its rapid expansion, according to Hong.
“With each plant we’ve built, we continuously acquiremore know-how and opportunity to adapt new regulations and standards,” said Hong. “This allows us to provide thehighest quality to our clients, while maintaining the most current compliance requirements.”
Furthermore, one team oversees the entire quality processacross Plants 1-4, enabling unified and consistent management. Thanks to this, it has been able to efficientlyimplement a quality system and minimize potential risks, even in new plants.
Samsung Biologics is also championing an FDA initiativeknown as Quality Management Maturity, which is intended to raise awareness – at all levels of management inthe pharma industry – about how to best achieve quality objectives. The goal of this initiative is for drugmanufacturers to have consistent, reliable, and robust business processes to achieve quality objectives andpromote continual improvement.
According to Hong, Samsung Biologics’ quality system hasadvanced immensely since its foundation. It allows them to take a proactive approach by identifying potentialdeviations in advance. Corrective and preventive actions can be designed pre-emptively, rather than takingmeasures after an issue is detected.
She added that the company is also trying to promote aquality mindset across the entire management.
“We’re planning to launch training programs for not justquality-related personnel, but the company as whole. This way, we can all understand the need for continuousquality improve and take initiative,” said Hong. “It’s about making GMP a culture.”
Samsung Biologics will continue to advance its qualitysystem and accelerate the development and manufacturing of high-quality, life-saving treatments for patientsaround the world. Plant 4 will be fully operational soon, and there will be additional plants tocome.
The company is committed to using expertise and digitalinnovation to make a positive impact on the healthcare industry.
Related Contents
Samsung BIOInsight Samsung Biologics’ Super Plant 4, How the world’s largest biomanufacturing plant will driveclients’ success
Webinars EQUIS: A Platform for Digital Transformation at Samsung Biologics