Date of publication: 1992-4-9
Date of implementation: 1992-6-1
Date of entry into force: 1900-1-1
Chapter I General Provisions
Article 1: Chinese herbal medicine concoctions are an integral part of the motherland's medicinal treasury, and they are the traditional pharmaceutical technology unique to the traditional Chinese medicine industry. In order to inherit and carry forward this traditional cultural heritage, and constantly improve the quality of tablets, to ensure that the clinical use of traditional Chinese medicine to identify and treat the disease is safe and effective, and hereby formulate these measures.
Second, the competent departments of traditional Chinese medicine at all levels should care about and attach importance to the production, operation and use of traditional Chinese medicine tablets management, the quality of traditional Chinese medicine tablets into the important agenda, the establishment of a sound quality management organization, with a person responsible for the quality of traditional Chinese medicine tablets management.
Article 3 Chinese medicine tablet manufacturers must implement the Chinese People's Republic of China *** and the State Drug Administration Law, the Chinese People's Republic of China *** and the State Standardization Law, the Chinese People's Republic of China *** and the State Measurement Law, and the "Regulations on the Liability for the Quality of Industrial Products," and other relevant laws and regulations, and to accept the higher Chinese medicine department in charge of the drug administration, the pharmaceutical inspection departments of the quality supervision and technical guidance.
Article 4 The production of Chinese medicine tablets should be based on the inheritance of traditional concoctions, and constantly explore, organize and improve, further strengthen the scientific research on the production of Chinese medicine tablets, and constantly promote the application of new technology, new techniques, new equipment and new materials, improve the overall quality of the enterprise, so as to enable the production of tablets to gradually realize the standardization of quality, the standardization of management, the mechanization of production, and the specification of packaging.
Chapter II Quality Management Organization
Article 5 Drinks production enterprises shall establish an independent quality management organization under the direct leadership of the factory director. Full-time quality management and quality inspection personnel shall account for 2 to 4% of the total number of employees of the enterprise (part-time quality inspectors shall be set up for beverage manufacturers with less than 20 employees).
Article VI must have the ability to organize and lead the production of traditional Chinese medicine tablets, familiar with the technical and business knowledge of the production of traditional Chinese medicine tablets.
Article 7 The person in charge of the quality management organization shall have the title of traditional Chinese medicine pharmacist or be engaged in traditional Chinese medicine for more than ten years, and have the practical experience in the preparation of traditional Chinese medicine, adhere to the principle of fairness and seriousness, and be able to manage the quality of the work after training as the person in charge of the quality management. Their appointment, dismissal and transfer must be agreed by the competent department of traditional Chinese medicine at the higher level of the enterprise.
Article VIII of the full-time quality inspection personnel should master the Chinese medicine concoctions and Chinese medicine identification techniques, competent from the acceptance of raw and auxiliary materials into the factory to the finished product out of the factory the whole process of quality inspection, and by the provincial and municipal departments in charge of traditional Chinese medicine training and licensing recognition. Has a secondary school degree or above in pharmacy full-time quality control personnel do not need training can be issued and recognized. Quality inspection personnel to maintain relative stability.
Article IX of the enterprise production workshop must be equipped with full-time or part-time quality inspector, responsible for the workshop quality supervision and inspection and quality inspection of semi-finished products. In the quality management inspection directly under the leadership of the enterprise quality inspection department. Whenever there is any objection to the quality of the products, it should be reported to the quality inspection department of the enterprise in time. Workshop full-time quality inspector candidates, mobilization, business leaders should seek the views of the quality inspection department.
Part-time production team quality inspector, every day should arrange a certain amount of time to carry out quality inspection work, and is responsible for the quality of the products of the team.
Chapter III Quality Management System
Article X Quality Responsibility System
Enterprises at all levels of administrative leadership, sections, workshops (shifts, groups), and warehouses and other segments should establish a quality responsibility system to clarify the quality of the department's quality work tasks, responsibilities and rights.
(A) the quality of the factory director responsibility system
Implementation of the state's quality management guidelines, policies and regulations. Responsible for the leadership of enterprise quality management, product quality is fully responsible. Presided over the convening of plant-level quality analysis, understanding and study of quality dynamics, the development of major measures to improve product quality, the organization of quality research, check the quality of the work plan and the implementation of the quality inspection personnel training program, to deal with major quality issues, the implementation of the quality of the system of rewards and penalties.
(2) Quality management department quality responsibility system
Quality management department is responsible for formulating the planning and measures to improve the quality of tablets; supervising the production department to strictly implement the quality standard of the production process of tablets; establishing mass quality supervision network, carrying out the quality inspection activities mainly based on the professional inspection and combining with the self-inspection and mutual inspection of the masses; being responsible for the quality management and daily inspection of the whole plant, and working with the relevant departments to improve the quality of the plant. It is also responsible for the quality management and daily inspection work of the whole factory, and improve the training of quality inspectors in conjunction with relevant departments. The quality management department has the right to reflect the quality situation at a higher level and accept the guidance of the higher Chinese medicine department.
(C) workshop (class, group) quality responsibility system
Workshop director (class, group leader) should be strictly in accordance with the process regulations and quality standards to organize production. The quality of the products produced by the workshop (class, group) is responsible for the quality of the product.
Article XI of the beverage quality file system
Enterprises should be produced according to the varieties to establish quality files. Contents include: the basis of quality standards, production process, the use of auxiliary materials, packaging materials, the name, specifications and quality standards, changes in the production process, the completion of quality indicators, sampling and observation, quality accidents, rework and return and quality information feedback. Quality file information should be complete, data should be accurate, filed in a timely manner, for continuous improvement of the production process, improve the quality of tablets to accumulate the necessary data.
Article XII Sample Observation System
Enterprises should establish a product sample observation system, which clearly specifies the species of samples to be retained; the number of batches, the number of items to be reviewed, review the period of time, and the time of retention of samples, etc.. Designated personnel to carry out examinations, research, and regularly make a good summary and sample observation records.
Article XIII of poisonous and anesthetic drugs management system
Enterprises must be in strict accordance with the State Council on December 27, 1988 issued the "Medical Toxic Drugs Management Measures" and November 28, 1987 issued the "Narcotic Drugs Management Measures," the provisions of the development of poisonous and anesthetic drugs, production, inspection, storage, sales management system.
Article XIV Quality Analysis System
Enterprises should establish and improve the three-level quality analysis system according to the scale of production. Factory, workshop, team should be held regularly to analyze the quality of analysis, serious research, analysis, improve the quality of tablets.
Article XV Quality Information Feedback System
Enterprises shall establish the idea of safe and effective service for the purpose of Chinese medicine clinic, and visit the wholesale and retail departments of the tablets and the medical units on a regular basis to collect quality information and analyze and deal with it in a timely manner. The quality of the internal production process of the enterprise should be timely feedback to the relevant departments, and seriously study the improvement.
Article 16 Quality Accident Reporting System
Quality accidents are divided into two categories: major accidents and general accidents. Scope of major quality accidents: (1) the factory has been found in the tablets mixed drugs, errors, serious foreign body mixing phenomenon or other major quality problems of a serious nature, so as to threaten the safety of medication or cause medical accidents; (2) as a result of the occurrence of quality accidents, an economic loss of more than three thousand dollars (not counting the hours of work). Scope of general accidents: not belonging to the above major accidents for general accidents.
Enterprises on the handling of quality accidents, must adhere to the cause of the unknown not to be spared, the responsibility is not clear not to be spared, the measures are not implemented not to be spared principle. After the occurrence of major quality accidents, should be immediately reported to the higher level of the competent department of traditional Chinese medicine, to be the cause of the investigation and then make a detailed written report, and copied to the State Administration of Traditional Chinese Medicine, shall not be concealed. After the occurrence of general accidents, the workshop, the team to analyze the causes, learn a lesson, put forward improvement measures, and sent to the quality inspection department for filing.
Article XVII of the measurement management system
Enterprises must strengthen the measurement of management work, the establishment of measurement files, and measurement of the management of the focal point of the department, set up a full-time and part-time measurement of the management personnel responsible for the weighing scales, scales, scales, scales and other gauges, appliances, instruments and laboratory equipment, etc., the use of the maintenance, safekeeping and the expiration of the delivery of the inspection, registry, and according to the national regulations to carry out the measurement of the grading, Upgrade work. National key Chinese medicine tablet factory should obtain a three-level measurement certificate.
Chapter IV Quality Monitoring
Article 18 The Chinese People's Pharmacopoeia and provincial, autonomous regions and municipalities directly under the Central Government Health Administration Department of the "Chinese medicine concoctions norms" is the legal quality standards of Chinese medicine tablets, enterprises must be strictly enforced. The State Administration of Traditional Chinese Medicine recommends the National Chinese Medicine Concoction Specification as the industry standard. Enterprises may, on the basis of the statutory quality standards, formulate internal control standards higher than the statutory quality standards to ensure the stability and improvement of the quality of the tablets.
Article 19 The raw and auxiliary materials and finished products of an enterprise must be strictly inspected by the quality management department at the factory level according to the standards, and the inspection report card shall be issued. Unqualified raw and auxiliary materials shall not be put into production, unqualified finished products are not allowed to leave the factory.
Article 20 In the production process, the quality inspection personnel have the right to stop the production behavior that does not comply with the process, and the unqualified semi-finished products are not allowed to enter the next process.
Article 21 The enterprise should be established in accordance with national and local standards for standard sample room (cabinet), in order to check against. Enterprises with the conditions to establish laboratories, equipped with appropriate instruments and equipment, the traditional experience of identification and scientific means of detection organically combined to meet the needs of modern management.
Article 22 of the technical departments and quality management of enterprises should be in accordance with the standards of raw and auxiliary materials, finished products and packaging materials, respectively, to develop sampling methods and inspection procedures. Sampling methods should be specified sampling containers, sampling volume and sampling methods: test procedures should include: name, character, identification, test items, test procedures, test methods. Enterprises should strictly enforce the sampling methods and inspection procedures, make original records, truthfully fill out the inspection report form.
Chapter V Quality Management of the production process
Article 23 Enterprises must be developed in accordance with legal standards and job operating procedures, and strictly according to the organization of its production, the preparation of production batch number, carefully fill out the process card and original records to achieve true, accurate, timely, complete, legible, change the signature. After the production of the whole file, save more than two years.
Article 24 The enterprise shall develop a clearance management system. In the replacement of varieties should be produced in the environment, equipment, legacy packaging clearance, and fill in the clearance record. Signed by the shift quality inspector agreed before replacing the production varieties. The same operation room shall not simultaneously produce and distribute different varieties of tablets, otherwise there should be effective measures to prevent confusion and cross-contamination. Drinking tablets before the packaging of a person to check, the product should be consistent with the label certificate of conformity.
Article 25 of the packaging of tablets to gradually realize the specification, standardization. Packaging materials should be conducive to preservation, storage, transportation, and shall not be contaminated with finished products. Packaging labels or certificates to indicate the name, quantity, batch number, production units and quality control seal.
Article 26 The factory should maintain a clean environment, no pollution sources around, the production area should be separated from the living area. The drying table shall be a special site with anti-pollution facilities, so that people do not step on the medicine, the car does not pressure the medicine. Toilets should be kept clean and gradually changed to flush type.
Article 27 The production workshop shall be divided into areas according to the requirements of the production process, the process is reasonably laid out, and equipped with equipment and ventilation facilities corresponding to the production of tablets, the production of raw and auxiliary materials, packaging materials, semi-finished products and finished products have the appropriate storage area, there is no cross-pollution and mixing. The production equipment should be kept clean and stored at fixed locations. The processed and concocted tablets are directly contained in clean containers. The production area shall not store non-production supplies.
Article 28 Provinces, autonomous regions, municipalities directly under the Central Government and municipalities with plans to implement the competent departments of traditional Chinese medicine, poisonous, numbing drugs, designated production, designated sales. Production enterprises should have a strict production site management system and receive and issue material formalities system, the implementation of two-person acceptance review, supervise the feeding. The production workshop, equipment and apparatus of poisonous and anesthetic drugs should be specialized and have obvious signs. After the end of production should be thoroughly cleaned equipment, appliances and site, to prevent cross-contamination.
Article 29 The production workshop should have a dressing room (cabinet) and washing facilities. In the production process is strictly enforced process hygiene system. On duty production workers should wear work clothes, work shoes, wear a work cap.
Article 30 of the personnel in direct contact with drugs at least once a year to conduct a physical examination, the establishment of health records. Infectious diseases and serious skin diseases, patients are strictly prohibited to engage in the production of tablets.
Chapter VI Warehouse Management
Article 31 The warehouse management is an important part of safe storage and quality assurance. Warehouses should have storage conditions suitable for the characteristics of drugs. The storage area should have safe ventilation facilities and the necessary means of controlling temperature and humidity, as well as pest control, rodent control, moisture, mold, pollution and other measures.
Article 32 The raw materials, auxiliary materials, packaging materials and finished products shall be stored in separate warehouses, classified, numbered, layered, according to the batch, neatly stacked, with a clear sign of the goods, the stacks should be left a certain distance from each other, and there is a channel to facilitate easy access to the drugs. The bottom of the stack has a cushioning measure.
Article 33 of the warehouse should be in accordance with the inspection, qualified, unqualified and returned to the place of separate storage, and yellow, green, red obvious signs, the implementation of color-coded management.
Article 34 The raw and auxiliary materials with the inspection report issued by the quality control department into the warehouse, and unified number. Storage should be filled in the arrival record (including the name, specifications, quantity, delivery unit, check quality, date of arrival, acceptance signature, etc.), and the strict implementation of the system of receiving and dispatching materials.
Article 35 of the finished product out of (in) storage should be registered name, quantity, production lot number, issued by the unit, the incoming truck room, out of (in) storage date, the handover signature. Implement the principle of "first in, first out". The establishment of sales records, returns to set up a separate account.
Article 36 of the poison, anesthesia and precious drugs should be stored separately, the establishment of the corresponding inventory maintenance facilities, and have a clear sign. The implementation of special people, special library (cabinet), special scales, double double-locked custody, the strict implementation of the two-person acceptance and verification system, so that the account, goods, cards are consistent.
Article 37 to establish a warehouse maintenance management system and in the warehouse drug inspection system, regular quality sampling of drugs in stock, take protective measures, make good maintenance records. The key conservation varieties to have special conservation measures.
Chapter VII personnel training
Article 38 The leadership of the enterprise should pay attention to the education of all employees, so that training is planned, implemented, assessed and registered. Often organize all staff for the "Chinese People's Republic of China *** and the State Drug Administration Law" and professional ethics education, enhance the concept of the rule of law, and establish the "quality first" idea. And in accordance with the needs of different positions on the staff for comprehensive quality management knowledge and professional and technical knowledge training, to carry out mass quality management activities and job training activities, and constantly improve the quality of the workforce.
Article 39 Where engaged in the processing and concocting, storage and maintenance of direct contact with the medicines of the post personnel, should be trained by the full range of business knowledge, and passed the examination before being allowed to operate.
Article 40 To give full play to the skill of the old medicine workers, take the form of teacher and apprentice, inherit and organize the traditional Chinese medicine concocting process, experience identification and operation skills, improve the business and technical level of the staff.
Chapter VIII rewards and punishments
Article 41 of the enterprise leadership should be included in the quality of tablets in the assessment of the enterprise's economic responsibility system, reflecting the principle of rewarding the best and punishing the worst, and the implementation of the quality of the veto power.
Article 42 of the enterprise on the annual quality indicators to complete a good collective and individual, should be given honorary and material incentives; on the failure to complete the quality indicators or quality accidents caused by the collective and individual, should be given to the criticism and education or financial penalties.
Article 43 of the quality inspection personnel, the main assessment of the quality of their work, and to give the appropriate rewards or criticism of education, incompetence to be transferred to work.
Article 44 The work of the quality inspection personnel is protected by the state law, the refusal to adopt the views of the quality inspection personnel, thereby causing quality accidents, as well as retaliation against the adherence to the principle of the quality inspection personnel, are to be investigated according to the law and seriously dealt with.
Chapter IX Supplementary Provisions
Article 45 The competent departments of traditional Chinese medicine in provinces, autonomous regions, municipalities directly under the Central Government and municipalities with separate plans shall, in accordance with this method, organize quality inspections of tablets; and formulate a quality assessment program for the same varieties, and carry out quality assessment activities of the same varieties on a regular basis.
Article 46 These measures since June 1, 1992 shall be implemented on a trial basis.
Article 47 The interpretation of these measures belongs to the State Administration of Traditional Chinese Medicine Quality Department.