KANION PHARMACEUTICAL

Declaration of Quality

Drugs are directly related to the life health of human beings. In line with the purposes of curing diseases, saving people, benefiting healthy people and serving the society, we solemnly promise that:

· We will strictly obey the Pharmaceutical Administration Law and control the quality to make sure qualified drugs flow into the market safely;

· We will strictly control material entrance and prevent non-conforming raw and auxiliary materials and packaging materials from entering production;

· We will strictly control drug production, organize production in strict accordance with Good Manufacturing Practice and strictly execute the approved technological procedure in order to guarantee standardized production process and realize well documented production quality;

· We will strictly control the clearance of finished products and inspect the finished products in strict accordance with the approved quality standards to make sure finished product inspection is legitimate, true and traceable, the whole production process conforms to the specifications and the drugs are qualified in the validity;

· We will strictly control market circulation to guarantee the quality of the drugs during transportation and storage;

· We will supervise layer by layer and establish a safety traceability system in order to produce high-quality drugs and better contribute the health of people.

Quality Policies and Targets

Quality Policies

· All activities of the company will follow the company philosophy of “simplicity, high aspiration, innovation and strive for first”;

· The company will establish a strict, scientific and systematic quality assurance system based on the guiding concept of “combining traditional medicine with modern science and technology”;

· We will stick to honesty, pragmatism, innovation and development, establish a first-class TCM enterprise and build an enterprise image of “high-quality traditional Chinese medicine made by Kanion”.

Quality Targets

· The annual product first-pass yield is not less than 99.7%;

· The sampling pass percent of marketed products is 100%;

· We will promote product quality through technological innovation, and the number of various technological reakthroughs is not less than 20 per year.

Quality Management System

Quality comes from design.Product quality is obtained by design and production, and is also obtained by management through a scientific and systematic quality management system. Drug quality comes from continuous innovation researches, comes from scientific and standardized production management and also comes from rigorous and precise process control. Kanion Pharmaceutical will strictly follow Pharmaceutical Administration Law of the People's Republic of China, elaborately build a whole process quality control system for modern Chinese medicine based on key technologies as the core support, and build solid safety production guarantee for quality management of dominant products including oral preparations, injections and crude drugs.

As guided by the core idea of “high-quality traditional Chinese medicine made by Kanion”, the company has developed the following quality management philosophy: “with GMP as benchmark, all staff will participate to establish a perfect quality management system to incorporate upstream and downstream suppliers and dealers into the enterprise quality management system. Our company will adopt advanced production an quality management technologies, and implement periodic review and continuous, stable and dynamic investigation of product quality through quality risk management, corrective and preventive actions in order to control drug quality well.”

Product quality management starts from the R&D phase, to implementation of GMP during production and risk assessment, to quality control of whole production process, to product promotion and sale and clinical application, covering whole-process systematic quality management of product life cycle. Starting from raw materials, GAP planting base management of traditional Chinese medicinal materials is implemented to ensure stable and uniform medicinal materials; the technology connotation of the products is effectively improved by technological verification and technological parameter risk assessment in the production process as well as advanced pharmaceutical technologies such as counter-current extraction, embrane separation, ultrafiltration and macroporous resin separation; the fingerprinting technology and the near-infrared on-line and off-line control technology is adopted in the whole production process from raw and auxiliary materials to intermediate products to finished products to ensure stable and uniform product quality; active joint monitoring with national adverse reaction institution, professional market academic promotion and professional compliant handling are adopted in the product after-sales tracking service to make sure product traceability. A closed-loop innovative and effective quality management system for the entire product life cycle is established covering product R&D, material usage, production process, quality control, product clearance and product after-sales service.