OUR OFFERING
End-to-End Support from
Pilot to Commercial Scale
Certified Production Capacity
Using systems proven to meet international standards, such as environmental management ISO 14001 frameworks, Genuone Sciences provides customers with tailored manufacturing services produced at state-of-the-art plants in South Korea.
Located in Sejong and Jecheon, the plants are also certified to comply with Korea Good Manufacturing Practice (KGMP) regulations. They are equipped with testing facilities and systems that can accommodate all necessary functions, including analyzing the suitability of raw materials used for pharmaceutical manufacturing; evaluating whether semi-finished and finished products are appropriate for each process step; and testing a range of product formulations.
We rely on an advanced technology system for drug development and production and have increased competitiveness by thoroughly rationalizing our production process. That led us to launch our “Global Total Health Care Services,” which provides customized pharmaceutical CDMO services from formulation development to finished product production.
- Sejong Plant
- Completed in 2002
- Total floor area: 32,816 m²
- Production capacity: 3.3 billion units per year
- Formulation capabilities: solids, oral liquids, topical medicines, ointments, pastes, sterile medicines, Lidcap®(lliquid-filled hard gelatin capsules) produced by Genuone Sciences proprietary technology
- Jecheon Plant
- Completed in 2010
- Total floor area: 46,193 m2
- Production capacity: 2.14 billion units per year
- Formulation capabilities: solids, ointments, soft capsules
Quality Benchmarks
The GENUONE Way, our corporate standard, encapsulates the core values as well as the Trust and Integrity code of conduct that defines Genuone Sciences. We uphold Good Manufacturing Practice (GMP) regulations and conduct continuous inspection and management to manufacture and supply excellent quality medicines.
We are comprised of seven teams. Four teams are responsible for quality control tasks. Three quality assurance teams include the quality management team, the quality assurance team and the process management team. Insights and input from all teams continuously inform our CAPA Quality system, or corrective and preventive actions, to support improvement and progress.
Responsibilities of Quality Management, Quality Assurance and Process Management Teams
- Directed by the Quality Management System, we implement systematic management and evaluation of all factors that may affect quality.
- We regulate management tasks with GMP standards, while establishing and documenting GMP procedures.
- We validate manufacturing processes, cleaning methods and computer systems and also perform production qualification tests of utilities, equipment and facilities.
- We assess and manage suppliers and vendors to verify all raw materials used to manufacture products.
- We periodically conduct quality audits to evaluate the effectiveness and adequacy of the QA system
- We manage and guarantee drug quality throughout the lifecycle by implementing our Quality Risk Management (QRM) system.
- Before authorizing any product shipment, we confirm that the drug has been produced and tested according to our manufacturing, quality control and other licensing standards.
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