Measures for Quality Management of Chinese Herbal Pieces Production Enterprises (for Trial Implementation)

Chapter I General Provisions Article 1 Processing of traditional Chinese medicine is an integral part of the treasure house of traditional Chinese medicine and a unique traditional pharmaceutical technology in the traditional Chinese medicine industry. In order to inherit and carry forward this traditional cultural heritage, continuously improve the quality of decoction pieces and ensure the safety and effectiveness of clinical medication of traditional Chinese medicine. Article 2 The competent departments of traditional Chinese medicine at all levels should care about and attach importance to the management of the production, operation and use of Chinese herbal pieces, put the quality of Chinese herbal pieces on the important agenda, establish and improve the quality management institutions, and designate special persons to be responsible for the quality management of Chinese herbal pieces. Article 3 Enterprises producing Chinese herbal pieces must implement the Drug Administration Law of People's Republic of China (PRC), the Standardization Law of People's Republic of China (PRC), the National Metrology Law of People's Republic of China (PRC) and the Regulations on the Quality Responsibility of Industrial Products, and accept the quality supervision and technical guidance of the superior departments in charge of Chinese medicine and the departments of drug administration and drug inspection. Article 4 On the basis of inheriting the traditional processing methods, the production of Chinese herbal pieces should continue to explore, sort out and improve, further strengthen the scientific research on the production of Chinese herbal pieces, continuously popularize and apply new technologies, new equipment and new materials, improve the overall quality of enterprises, and gradually realize the standardization of quality, management, production mechanization and packaging in the production of Chinese herbal pieces. Chapter II Quality Management Organization Article 5 Piecework production enterprises shall establish an independent quality management organization, which shall be directly led by the factory director. Full-time quality management and quality inspection personnel should account for 2 ~ 4% of the total number of employees in this enterprise (the production enterprises of decoction pieces with less than 20 employees should have part-time quality inspection personnel). Article 6 The factory director must have the ability to organize and lead the production of Chinese herbal pieces, and be familiar with the technical and business knowledge of Chinese herbal pieces production. Article 7 The person in charge of a quality management institution shall be a person who has the title of Chinese medicine pharmacist or has been engaged in Chinese medicine work for more than ten years, has practical experience in Chinese medicine processing, adheres to principles, is fair and earnest, and has passed the training. Its appointment and transfer must be approved by the superior Chinese medicine department of the enterprise. Article 8 Full-time quality inspectors shall master the processing and identification technology of traditional Chinese medicine, be competent for the whole process of quality inspection from raw materials to finished products, and hold relevant certificates after being trained by provincial and municipal departments in charge of traditional Chinese medicine. Full-time quality inspectors with pharmaceutical professional education above technical secondary school can issue certificates without training. Quality inspectors should remain relatively stable. Article 9 The production workshop of an enterprise must be equipped with full-time or part-time quality inspectors who are responsible for the quality supervision and inspection of the workshop and the quality inspection of semi-finished products. In quality management inspection, it is directly led by the quality inspection department of the enterprise. If you have any objection to the product quality, you should report it to the quality inspection department of the enterprise in time. Enterprise leaders should seek the opinions of the quality inspection department when selecting and mobilizing full-time quality inspectors in the workshop.

The part-time quality inspector of the production team should arrange a certain time for quality inspection every day and be responsible for the product quality of the team. Chapter III Quality Management System Article 10 Quality Responsibility System

Enterprise administrative leaders at all levels, departments, workshops (classes, groups) and warehouses should establish a quality responsibility system, and clarify the tasks, responsibilities and rights of quality work in their own departments.

(A) the factory director quality responsibility system

Implement the quality management guidelines, policies and regulations stipulated by the state. Responsible for leading enterprise quality management and taking full responsibility for product quality. Preside over the factory-level quality analysis meeting, understand and study the quality trends, formulate major measures to improve product quality, organize quality research, check the implementation of quality work plan and quality inspection personnel training plan, deal with major quality problems, and implement the quality reward and punishment system.

(2) Quality Responsibility System of Quality Management Department

The quality management department is responsible for making plans and measures to improve the quality of the pieces; Supervise the production department to strictly implement the quality standards of the production process of decoction pieces; Establish a mass quality supervision network and carry out quality inspection activities that focus on professional inspection and combine mass self-inspection and mutual inspection; Responsible for the quality management and daily inspection of the whole plant, and do a good job in training quality inspection personnel in conjunction with relevant departments. The quality management department has the right to reflect the quality situation and accept the guidance of the superior Chinese medicine department.

(three) workshop (class, group) quality responsibility system

Workshop director (monitor) should organize production in strict accordance with process regulations and quality standards. Be responsible for the quality of products produced in this workshop (class or group). Eleventh quality document system

Enterprises should establish quality files according to production varieties. The contents include: the basis of quality standards, production technology, the names, specifications and quality standards of auxiliary materials and packaging materials used, the transformation of production technology, the completion of quality indicators, sample observation, quality accidents, rework and return, quality information feedback, etc. Quality files should be complete, accurate and timely, and accumulate necessary data for continuous improvement of production technology and quality of decoction pieces. Article 12 Sample Retention and Observation System

Enterprises should establish a product sample observation system to clarify the sample varieties; Batch number, quantity, re-inspection items, re-inspection cycle, sample retention time, etc. Designate a special person to carry out inspection and study, and make summary and sampling observation records regularly. Article 13 Drug management system

Enterprises must work out the production and inspection of toxic drugs and narcotic drugs in strict accordance with the Administrative Measures for Toxic Drugs for Medical Use issued by the State Council 19881February 27th and the Administrative Measures for Narcotic Drugs issued by 19871February 28th.