Our QMS establishes standards for planning of quality outcomes, executing the planned activities, monitoring and measuring results, analyzing the data, and correcting or improving those activities.
Samsung BioLogics’ Quality Unit functions independently from Operations. The Quality and Compliance department is responsible for ensuring that all cGMP processes comply with regulatory guidelines and requirements.
The Quality Systems ensure that all equipment and systems are maintained throughout cGMP production and our products are of high quality. The Quality and Compliance department provides the proper oversight of release and / or rejection of raw materials, intermediates, products, packaging, and labeling materials, and proper maintenance of critical equipment and instruments.
Quality and Compliance reviews and approves all Specifications, Standard Operating Procedures (SOPs) and Master Batch Records (MBRs) as well as investigations for any product or facility related deviations. We have an established training program, which ensures that personnel involved in cGMP operations are qualified to do so. In addition, a documentation management system is in place to ensure controlled generation, approval, and retention of all cGMP documents. Scheduled periodic internal audits and management reviews ensure that our quality systems are effective.
Samsung BioLogics Quality & Compliance is fully committed to quality management of continuous improvement through Corrective Action Preventive Action (CAPA) effectiveness checks and evaluation, quality risk assessments, our supplier audit program, in-process management review, and self-inspection program. Through the activities of our Quality & Compliance department, Samsung BioLogics maintains compliance with international regulations for cGMP.