品質管制體系

Our drug production is subject to GMP certification. In July 2018, our production lines of tablets, granules, hard capsules, pills, lozenges, powders, tea preparations, raw materials (artificial yellow) and traditional Chinese medicine decoction pieces passed the GMP certification of drug version 2010. The company has formulated the quality manual in strict accordance with GMP requirements, elaborated the company's quality policy and quality objectives, continuously improved the enterprise document control system, and established and improved the enterprise quality management system.

Quality policy: efficient and pragmatic, continuous improvement; Compliance, customer first. Its connotation reflects our pragmatic work style and improvement concept; Management concept based on good faith and focusing on the needs of users. With the training of "empty talk mistaking the enterprise and doing solid work to promote business", seek truth from facts, strive to solve problems and improve work performance, so as to continuously improve the overall performance of the company. Employees are required to continuously improve, improve efficiency and ensure quality based on their own work. Based on honesty, abide by commitments and pay attention to user needs. The company abides by the commitment of "being a healthy person and becoming a healthy thing", standardizes the company's business work according to the requirements of "keeping a zero distance from the market", continuously provides users with current and future expected products, meets users' needs, satisfies users, and satisfies the society, employees and shareholders.

In recent years, the company has undertaken a number of major national, provincial and municipal projects, and has obtained 10 invention patents and 14 utility model patents. Among them, "Research on babaodan capsule and related technologies" (2019zx9201005-002-005) was listed as a major national science and technology project in 2019; "Clinical reevaluation study of osteoporosis drug Qigu capsule after listing" was selected as the subject of Shanghai scientific research plan.

Quality assurance document system

Quality control technology

The quality management department of the company has a testing and analysis department, a laboratory, specimen room, sample retention observation room, bacteria testing room, precision instrument room, packaging inspection room and other professional rooms, and is equipped with advanced testing instruments at home and abroad such as visual microscope, high performance liquid chromatograph, gas chromatograph, atomic absorption spectrophotometer, ultraviolet spectrophotometer and thin layer chromatography scanner, It is used for drug identification, content determination, detection of harmful elements (heavy metals, pesticide residues, etc.) and detection of purified water. It can inspect raw and auxiliary materials, medicinal materials, packaging materials, intermediate products and finished products according to standards, and strictly control their quality to ensure drug quality.

<p>"Quality benchmark" of national industrial enterprises in 2014---- Implement production site management based on "GMP risk management"</p><p>Xiamen Traditional Chinese Medicine Co., Ltd. has been implementing total quality management since the 1980s. It has actively organized mass quality management activities such as QC group activities, quality month activities, on-the-job training and rationalization suggestions among employees, which has laid a good and solid foundation for building a perfect quality management system. After the relocation of the new plant, Xiamen traditional Chinese medicine effectively applied the GMP risk management method to the management of the production site, identified the risks in the production site management, analyzed and evaluated, eliminated or reduced the existing risks by means of 5S and QC group activities, and effectively solved the difficulties in the production site management caused by the new plant, new process and new equipment, It has promoted the continuous improvement of Xiamen traditional Chinese medicine quality management system, improved the quality management level, and injected new vitality into the sustainable development of the company.</p><p>2018 "quality benchmarking" of industrial enterprises in Fujian Province -- practical experience in implementing quality management of "combination of GMP and Lean Six Sigma"</p><p>Combined with years of management and development experience, the company continues to explore the development path suitable for Xiamen traditional Chinese medicine. Develop and innovate a quality management road of "combination of GMP and Lean Six Sigma" with the characteristics of Xiamen traditional Chinese medicine. The company strives to build a management system combining GMP and Lean Six Sigma, fully introduces the Lean Six Sigma management concept, including quality awareness, production management, equipment management, training system, etc., realizes the fine management of production and manufacturing system, and comprehensively uses a variety of quality assurance control tools and means in the production process, Monitor key process parameters and quality indicators from time to time, implement continuous improvement, and achieve the quality objectives of process improvement and continuous improvement of management level. Creatively put forward the quality management system based on GMP, supplemented by the advanced improvement tools and methodology of Lean Six Sigma, organically combine GMP and Lean Six Sigma, break through the current quality management bottleneck, continuously extend the direction of quality management to refinement and deepening, and constantly improve and sublimate it, Realize the quality management system combining GMP and Lean Six Sigma.</p><p>After three years of practice, Xiamen traditional Chinese medicine has put forward the quality management practice road of "combination of GMP and Lean Six Sigma", paid attention to management effectiveness, carried forward the quality concept, and fundamentally improved the existing GMP management level. Lean Six Sigma has successfully run through the GMP quality management system. In the process of bit by bit improvement, it has helped Xiamen traditional Chinese medicine quality management system make a new leap, revitalize the stable quality management system, and inject new vitality into the sustainable development of the company. It is effective for enterprises to improve brand value and customer loyalty, and provides effective quality management strategies and successful reference models for the majority of pharmaceutical manufacturers.</p><p><br/></p>
<p>All along, our company has followed the quality development policy of continuous improvement, made continuous progress with the support of self-examination and partners of all parties, and wholeheartedly provided high-quality products and services for partners and users. Focusing on the needs of users, the company clarifies its responsibilities to customers, continuously provides users with products expected at present and in the future, adheres to the slogan of "all for customers and customer satisfaction for all customers", continuously implements the quality policy of "high efficiency and pragmatism, continuous improvement, compliance and customer first", and implements the implementation of user satisfaction project in all work of the company, From the company's customer management and maintenance, standardized production operations, implementation of Lean Six Sigma management, construction of quality trusted teams and other measures, we have built a quality management system covering the whole product life cycle from R & D to production and sales, guaranteed and continuously improved the quality of products, paid attention to and continuously met the needs of users, and improved customer satisfaction. Since 2014, our company has won the title of "user satisfaction service unit" for many consecutive years, and has established a good brand image in the hearts of the majority of users.</p>
<p>QC group is "a group of employees engaged in various labor in production or work positions, which is organized for the purpose of improving quality, reducing consumption, improving human quality and economic benefits around the business strategy, policies and objectives and on-site problems of the enterprise, and carries out activities by using the theories and methods of quality management". QC group is an effective organizational form of mass quality management activities in enterprises and one of the effective ways for employees to participate in the implementation of GMP.</p><p>Since the 1980s, the company has implemented total quality management and encouraged QC activities. Taking solving practical problems as the starting point, learning from and promoting advanced management concepts, technologies and methods, actively looking for topics, tackling key technical problems, continuous innovation and continuous improvement in specific work links such as production, R & D and management, which not only solves a series of practical problems in production and work, but also improves the learning ability, application ability, innovation ability The executive ability and self-management ability have been significantly improved.</p><p>1. The company won the national pharmaceutical industry excellence promotion organization in 2019;</p><p>2. Mr. Wang Shifa, general manager of the company, was awarded the outstanding promoter of the national quality management group in 2019;</p><p>3. Mr. Wang Shifa, general manager of the company, won the outstanding leader of Fujian quality management group in 2020;</p><p>4. Comrade Lin Lihong of the quality management department is the quality model of the national quality management group in 2019</p><p>5. Comrade Lin Lihong of quality management department, outstanding promoter of Fujian quality management team in 2020;</p><p>6. The QC team of exploration and change of the detection and analysis department was awarded the outstanding quality management team of Fujian Province in 2019;</p><p>7. Innovation and standard building QC team of R & D department, Xiamen excellent quality management team in 2020.</p><p><br/></p>
<p>Team is an active cell of the enterprise, a platform connecting the enterprise and employees, and an important position for cultivating employees and motivating talents. In order to improve the core competitiveness of the enterprise, the team management level and the quality quality of the staff, strengthen quality management and improve the quality of products, services and work, the company actively strengthens the construction activities of teams with reliable quality. Since 2019, two teams of the company have won the titles of "trustworthy" teams of national and provincial quality respectively, as follows:</p><p>1. The crushing team won the quality trust team of China Quality Association in 2019.</p><p>2. The second packaging team won the quality trust team of Fujian Quality Association in 2020.</p><p><br/></p>