Chapter 1 General Provisions Article 1 The processing of traditional Chinese medicine is an integral part of the motherland’s medical treasure house and a traditional pharmaceutical technology unique to the traditional Chinese medicine industry. In order to inherit and carry forward this traditional cultural heritage, continuously improve the quality of the decoction pieces, and ensure the safety and effectiveness of clinical medication for TCM diagnosis and treatment, these measures are specially formulated. Article 2 The Chinese medicine authorities at all levels must care about and attach importance to the management of the production, operation, and use of Chinese medicine pieces, include the quality of Chinese medicine pieces on their important agenda, establish and improve quality management institutions, and assign dedicated personnel to be responsible for the quality management of Chinese medicine pieces. Article 3 Enterprises producing traditional Chinese medicine pieces must implement the "Drug Administration Law of the People's Republic of China", the "Standardization Law of the People's Republic of China", the "Measurement Law of the People's Republic of China" and the "Industrial Product Quality" Responsibility Regulations" and other relevant laws and regulations, and accept quality supervision and technical guidance from the superior Chinese medicine authorities and pharmaceutical administration and drug inspection departments. Article 4 The production of traditional Chinese medicine pieces should be continuously discovered, sorted out and improved on the basis of inheriting the traditional processing methods, further strengthening the scientific research on the production of traditional Chinese medicine pieces, constantly promoting the application of new processes, new technologies, new equipment and new materials, and improving The overall quality of the enterprise has enabled the production of decoction pieces to gradually realize quality standardization, management standardization, production mechanization, and packaging standardization. Chapter 2 Quality Management Organization Article 5: Decoction piece manufacturing enterprises should establish an independent quality management organization under the direct leadership of the factory director. Full-time quality management and quality inspection personnel should account for 2 to 4% of the total number of employees in the enterprise (piece production enterprises with less than 20 people shall have part-time quality inspectors). Article 6 The factory director must have the ability to organize and lead the production of traditional Chinese medicine pieces and be familiar with the technical and business knowledge of the production of traditional Chinese medicine pieces. Article 7 The person in charge of the quality management agency shall be a person who has or is equivalent to the title of Chinese pharmacist or has been engaged in Chinese medicine work for more than ten years, has practical experience in the processing of Chinese medicine, adheres to principles, acts fairly, works conscientiously, and is trained to be competent in quality management work. . Their appointment, removal and transfer must be approved by the enterprise's superior Chinese medicine authority. Article 8 Full-time quality inspection personnel should master traditional Chinese medicine processing and traditional Chinese medicine identification technology, be competent in the quality inspection work of the entire process from the acceptance of raw materials and auxiliary materials to the delivery of finished products, and be certified and approved after training by the provincial and municipal competent authorities of traditional Chinese medicine. Full-time quality inspection personnel who already have a pharmacy degree or above from a technical secondary school can issue certificates and accreditation without training. Quality inspection personnel 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 terms of quality management inspection, he is directly under the leadership of the enterprise's quality inspection department. Any objections to product quality should be reported to the company's quality inspection department in a timely manner. Company leaders should seek the opinions of the quality inspection department on the selection and transfer of full-time quality inspectors in the workshop.
Part-time quality inspectors in the production team should arrange a certain amount of time every day to conduct quality inspection work and be responsible for the product quality of the team. Chapter 3 Quality Management System Article 10 Quality Responsibility System
Administrative leaders at all levels of the enterprise, departments, workshops (classes, groups), warehouses and other links must establish a quality responsibility system to clarify the quality work of the department. Tasks, Responsibilities and Rights.
(1) Factory Director Quality Responsibility System
Implement the national quality management guidelines, policies and regulations. Responsible for the leadership of enterprise quality management and overall responsibility for product quality. Host factory-level quality analysis meetings to understand and study quality trends, formulate major measures to improve product quality, organize quality research, inspect the implementation of quality work plans and quality inspection personnel training plans, handle major quality issues, and implement the quality reward and punishment system.
(2) Quality responsibility system of the quality management department
The quality management department is responsible for formulating plans and measures to improve the quality of the pieces; supervising the production department to strictly implement the quality standards of the production process of the pieces; establishing a mass We have established a comprehensive quality supervision network to carry out quality inspection activities that focus on professional inspections and combine mass self-inspection and mutual inspection. We are responsible for the quality management and daily inspection of the entire factory, and work with relevant departments to provide training for quality inspection personnel. The quality management department has the right to report the quality situation beyond the next level and accept the guidance of the superior Chinese medicine authority.
(3) Workshop (squad, group) quality responsibility system
The workshop director (squad, group leader) must organize production in strict accordance with process regulations and quality standards. Responsible for the quality of products produced by this workshop (squad, group). Article 11 Quality File System for Decoction Pieces
Enterprises should establish quality files according to production varieties. The content includes: the basis of quality standards, production processes, product names, specifications and quality standards of excipients and packaging materials, changes in production processes, completion of quality indicators, sample observation, quality accidents, rework and returns, quality information feedback, etc. The quality archive information must be complete, the data must be accurate, and the filing must be timely, so as to accumulate necessary data for continuously improving the production process and improving the quality of the slices. Article 12 Sample retention and observation system
Enterprises must establish a product sample retention and observation system and clearly stipulate the types of samples to be retained; batch number, quantity, review items, review period, sample retention time, etc. Designate a dedicated person to conduct inspections and research, and make regular summaries and sample observation records. Article 13: Toxic and Narcotic Drugs Management System
Enterprises must strictly comply with the "Measures for the Management of Toxic Drugs for Medical Use" promulgated by the State Council on December 27, 1988 and the 1987 According to the provisions of the "Measures for the Administration of Narcotic Drugs" issued on November 28, a management system for the production, inspection, storage, and sales of narcotic and narcotic drugs was formulated.