In accordance with the requirements of the Drug Administration Law of the People’s Republic of China, the Vaccine Administration Law of the People’s Republic of China, the Good Manufacturing Practice (revised in 2010) and the Quality Management System (GB/T19001-2016), OLYMVAX has established and improved a quality management system in line with the needs of its own development. This system takes charge of the comprehensive quality management of vaccines throughout their life cycle, with such major procedures and processes as quality policy and objective management, organization and personnel management, quality system review, document management system, material management system, equipment management system, clean environment control system, verification/validation management, measurement management, quality inspection management, manufacturing process management, quality assurance management, product and shipment management, risk management and data management, pharmacovigilance and adverse drug reaction reporting and monitoring management, with risk management throughout the product life cycle and all management activities related to product quality.
OLYMVAX has established and released the quality policy (namely, strengthening process management, focusing on continuous improvement, and pursuing the highest quality) of the Company, set up quality objectives, and decomposed them step by step, covering various aspects such as product production, material management, product inspection, equipment management, and personnel training, fully implementing them throughout production process and product life cycle. In order to ensure the applicability and effectiveness of the quality policy and objectives, the quality system review meeting is held regularly to review the quality policy and objectives and guide the further improvement of the Company’s quality management system.
The Company takes the quality manual as the programmatic document of quality management system, which aims to describe the scope, operation mode, interrelationships between system processes and relevant procedures of the Company’s quality management system. It is regarded as an outline to establish a comprehensive drug quality management system, with documents as the carrier, training and assessment as the means, standardized management and operation, process supervision, and comprehensive quality control measures to ensure product quality.
We center on the Company's quality policy and objectives, adhere to honesty and trustworthiness, get all employees to participate in continuous improvement, ensure the quality of drugs and the safety of human medication based on a perfect quality management system.