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Quality Management

Our company adheres to the quality control concept of always maintaining consistency with the world's leading product access level, designing and constructing production lines according to international advanced standards, and configuring intelligent, digital production and testing equipment. Based on the full lifecycle quality control system implemented in drug research and development, drug production, quality control, product release, storage, transportation, and post market monitoring, we comprehensively guarantee product quality and safety through a strict quality testing and risk monitoring system, safeguarding patients’lives and health.

We actively follow the internationalization strategy, and have sold key formulations and APIs to Europe, America, Japan and other countries or regions; all sites have gained the ISO9001 quality management system certification; and all products have obtained the official GMP certification in China.

Quality-oriented Concept and Quality Policy

Our company adheres to the concept of "Quality by Design (QbD)", focuses on the production quality strategy of "lean manufacturing, quality improvement, efficiency enhancement and green development", and practices the quality policy of "all members, whole process and continuous improvement" to realize the quality management throughout the life cycle of drugs.

Quality Advantage

01

A scientific and comprehensive quality management system is in place.
Risk prevention and control covers the life cycle of drugs.
02

International advanced production and testing equipments have been introduced.
Integration of industrialization and informationization is promoted.
03

Process improvement and standard enhancement are promoted continuously.
Our company continuously improves the level of drug quality and safety.

Quality Management Throughout the Life Cycle of Drugs

Drug development and design

We carry out comprehensive drug quality and safety risk assessment in terms of drug characteristics, toxicology research and clinical research, determine key quality attributes and key process parameters of products, establish process design space, process control indexes and final product quality standards, and lay an excellent quality foundation through rigorous R&D design.

Market tracking and monitoring

We strictly perform our responsibility for safety, establish an effective pharmacovigilance management system, develop post-marketing risk management plans for drugs, take the initiative to carry out post-marketing research on drugs, further confirm the safety, efficacy and quality controllability of drugs, minimize drug safety risks, protect and promote public health, and realize the whole life cycle management of drugs.

Drug technology transfer

We transfer drug knowledge, technology and related products and processes from the drug development stage to the production stage, while continuously identifying and evaluating improvement opportunities, optimizing process technologies or routes, and strictly implementing process validation to ensure safe, stable, and reliable drug production process.

Commercial production of drugs

The company establishes a scientific and comprehensive quality management system, use FMECA, FTA and other risk management tools to conduct risk assessment on drug production and quality control process from five aspects of human, machine, material, method and environment, develop corrective and preventive measures, regularly review the controllability of risks, continuously improve the quality management system, and control the quality risks of drug production, in order to ensure that drugs are safe, effective and controllable.

Drug development and design

Drug technology transfer

Commercial production of drugs

Market tracking and monitoring