As a part of the quality management system, quality assurance is effectively ensured based on a complete system of documents.
Our products are strictly controlled in accordance with GMP requirements during the whole process from materials procurement, products production, inspection to marketing. The responsibilities are clarified for key personnel such as the persons in charge of the corporation, production and quality, quality-authorized persons, as well as responsible persons in each department and workshop. The product quality is strictly controlled in the selection of material suppliers, on-site quality inspection and evaluation. And the quality of raw materials, auxiliary materials and packaging materials are effectively controls at procurement process. Moreover, the material inspection and distribution management measures are taken, guaranteeing that only source materials pass quality inspection, can they be put into use, to ensure the quality of source materials. What’s more, quality evaluation and retrospective analysis of materials and credit evaluation of suppliers are carried out to make sure that the purchased materials meet the quality requirements of drugs.
In addition, verification and confirmation are made for all instruments, devices and technologies of the inspection and production of the corporation. Regularly self-inspections are organized to rectify problems. And the investigation, analysis and evaluation are carried out to avoid deviation, alteration and quality risks.
The quality inspection of raw and auxiliary materials, packaging materials, intermediate products and finished products shall be conducted by the quality assurance personnel, who must guarantee 100 percent qualified rate of sampling products in market without allowing the unqualified materials, intermediate products and finished products to flow into the next process or enter the market. We strictly implement the conformity inspection of the whole process of production and quality inspection and control. The finished products can be finally reviewed and released only after they fully meet the technological requirements and quality standards after being reviewed by the authorized persons.