Factory Facilities, Equipment and Technology Systems
Genfarma places strong emphasis on investing in modern factory facilities, production lines, equipment and technologies, developed in a synchronized and highly automated manner to enhance process control in the biopharmaceutical manufacturing environment. Operational systems and data management systems are implemented to support production process monitoring, improve quality control effectiveness and ensure operational stability.
The technology infrastructure and equipment systems are developed in accordance with requirements aligned with international practices for data management and operations in the pharmaceutical industry, including requirements related to electronic records, audit trails and data integrity under 21 CFR Part 11 and GAMP 5.
Research and Development Center (R&D)
R&D activities focus on formulation development, stability assessment, production process optimization, support for research and clinical trials, as well as technology transfer and product commercialization in accordance with international standards.
Through cooperation with leading biopharmaceutical manufacturers worldwide, Genfarma aims to receive, apply and gradually master advanced technologies, contributing to the enhancement of domestic manufacturing capabilities and promoting the development of the biopharmaceutical industry in Vietnam.
Manufacturing Process
In the initial phase, Genfarma focuses on investing in and operating sterile biopharmaceutical production lines, with key stages including solution preparation, filling, lyophilization and packaging. The production system is designed to be synchronized, automated and integrated with monitoring and data management solutions to support production process control, quality management and operational stability, in line with the orientation of 21 CFR Part 11 and GAMP 5.
In subsequent development phases, Genfarma aims to expand its research and manufacturing capabilities for active ingredients, excipients and raw materials used in biopharmaceutical production, gradually completing the biopharmaceutical manufacturing value chain in Vietnam.
Solution Preparation
The solution preparation area is equipped with 316L stainless steel tank systems in various capacity ranges, meeting the flexibility requirements of biopharmaceutical research, development and manufacturing activities. The system integrates mixing, heating/cooling and automated monitoring technologies to support temperature control, mixing process control and solution uniformity during production.
Sterile Filling and Lyophilization
The sterile filling and lyophilization system is designed in a synchronized manner to meet control requirements in sterile biopharmaceutical manufacturing. The production line includes vial washing, depyrogenation, filling, stoppering and lyophilization systems to support the maintenance of appropriate conditions during production and ensure product stability throughout operation.
Packaging and Quality Control
The packaging line is designed as an integrated system with inspection, labeling, cartoning and case-packing systems, operated automatically or semi-automatically, to support product management, traceability and quality control during the packaging process.
Quality Control Laboratory (QC)
Genfarma’s Quality Control Laboratory is developed to support quality control and quality assessment activities throughout the biopharmaceutical research and manufacturing process.
The QC Laboratory supports quality testing of raw materials, semi-finished products, finished products and in-process samples in accordance with established quality control procedures, contributing to quality assurance, product stability and data traceability during operation.