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Some manufacturers of decoction pieces of traditional Chinese medicine currently have lax internal self-discipline and weak external supervision, which seriously threatens the healthy development of the whole decoction pieces of traditional Chinese medicine industry and people’s medication safety. The promulgation and implementation of the new version of GMP provides guidance for the standardized operation of Chinese herbal medicine manufacturers. But in reality, there are many problems in the implementation of GMP due to many factors, and the effective implementation of the new version of GMP is of great benefit to solving these problems. We should explore effective control measures and develop targeted solutions. This paper will discuss the production quality management of Chinese herbal medicines under the new GMP environment, in order to provide a reference for improving the quality of Chinese herbal medicines.
As one of the three pillars of traditional Chinese medicine, Chinese herbal decoction pieces refer to traditional Chinese medicines that can be formulated and applied after processing according to needs or can be directly used in clinical treatment. Therefore, its quality is directly related to the patient’s medication safety and The process of modernization, industrialization and internationalization of traditional Chinese medicine. With the expansion of the Chinese medicine market and the rapid development of the Chinese medicine decoction pieces industry, the market demand for Chinese medicine decoction pieces has increased significantly. In this environment, the Chinese government has continuously strengthened the supervision of the Chinese medicine industry while introducing a large number of industrial support policies. It has laid the foundation for the healthy development of traditional Chinese medicine.
Part 1 Current Status Of Production Quality Management Of Chinese Herbal Decoction Pieces
1.1 Personnel
At present, the defects in the production quality management of traditional Chinese medicine decoction pieces enterprises are mainly due to the failure to report to the relevant departments in time when the positions of the legal representative, responsible person or production director of the production enterprise change. In addition, most of the persons in charge of quality management lack QA management experience, and there are few QA professionals in the enterprise, making it difficult for employees to perform their duties correctly. In addition, there are unreasonable situations in the establishment of some enterprise organizations, and most of the production and quality managers are concurrently in charge. Most of the quality control personnel go to work without professional training. The general defect is reflected in the fact that most of the new recruits have not received professional pre-job training. Even if some enterprises conduct training, it is mostly general training, lacking targeted professional knowledge training on Chinese herbal medicines. The quality inspection management personnel and some operation management personnel also have insufficient job training. Analyzing the causes of these deficiencies, the main reason is that enterprise management personnel have not fully understood and mastered the relevant content of China’s current pharmaceutical laws and regulations, and lacked sufficient legal awareness.
1.2 Plant And Facilities, Equipment
The layout of workshops for the production of Chinese herbal medicines in some enterprises is unreasonable, and there are many situations that do not comply with GMP in individual production operations. At present, due to the long construction time of some traditional Chinese medicine decoction factories in China, there are situations such as insufficient land occupation, unreasonable original design production process and layout, and outdated factory buildings and facilities. In addition, there are also problems such as incomplete operation records of the purification air-conditioning system, untimely update of the calibration certificate of the weighbridge, untimely calibration of the automatic packaging machine instrument, untimely review of testing data, and untimely repair of damage to some testing tools.
1.3 Materials And Products
At present, some enterprises have not re-inspected the raw materials of traditional Chinese medicine when they expired, and some warehouses used to store toxic Chinese medicine decoction pieces lack the signature of the reviewer when they deliver goods, and the unqualified warehouses are not locked for management. The location card information of the material is incomplete, and the raw materials of traditional Chinese medicine and the prepared decoction pieces are mixed and stored. Raw materials and decoction pieces in the warehouses or temporary warehouses of some enterprises and workshops are stored at will without status identification or location cards; there are also medicinal materials in the workshops of some enterprises that are piled up anywhere, and cooling measures have not been taken in time in the cool warehouses. Some raw materials in the raw material warehouse have no supplier and origin identification on the outer packaging, and the raw material purchase account has not been established in time.
1.4 Confirmation And Verification
Some enterprises did not carry out process verification in the mixing process or failed to verify the temperature design of the automatic packaging machine in time, which made the set stable data unfounded in the production and processing process. In addition, there are still situations where the confirmation and verification documents are incomplete, and the temperature distribution of the cool storage room cannot be confirmed in time.
1.5 File Management
Some enterprises often use high-performance liquid chromatography or ultraviolet spectrophotometry to identify the content of traditional Chinese medicine raw materials and decoction pieces. However, in the actual operation process, they often fail to establish the corresponding detection operation specification process correctly, and do not formulate computer-controlled automatic packaging in accordance with relevant regulations. Equipment production operating procedures. Some operating steps in the “Operating Procedures for Rapid Moisture Determination” are not detailed; the “Product Recall Management Regulations” have not been able to be corrected and revised in accordance with the latest national regulations; The destruction record is missing; the survival record is not recorded in time according to the relevant regulations, or the content of the survival record is incomplete.
1.6 Production Management
In the process of production or storage, there are cases where the packaging bags of decoction pieces are used many times, and there are no relevant management regulations. In the process of processing, the processing cannot be carried out accurately in accordance with the relevant process specifications. The decoction pieces are easily polluted during the production process; when multiple varieties of decoction pieces are processed in the same production operation workshop, the product status identification is incomplete, and various decoction pieces of different varieties lack isolation measures during the processing; some The packaging date of the decoction pieces does not match the actual production date; the batch production records of some decoction pieces are filled in advance or late; there is no status mark for the decoction pieces in the production workshop.
1.7 Quality Management
Quality management defects are mainly due to the failure to identify raw materials and decoction pieces in a timely manner, and the failure to measure pesticide residues, aflatoxin, heavy metals, and other harmful substances in a timely manner; The release of decoction pieces is just a formality. The approval date filled in the “finished product release form” is usually earlier than the audit date filled in the “production batch record summary and material balance sheet”, and the two audits are mostly by the same person. The refrigerated time of the medicinal material solution and the reference substance solution used in the identification control of traditional Chinese medicine raw materials exceeds 6 months, and no stability check was carried out when used during storage. The list of qualified suppliers presented by some enterprises is not controlled, and some contents are incomplete and false. The warehouse site lacks a relatively complete list of qualified suppliers. The management personnel of the company do not have enough understanding of the current relevant laws and regulations in China, and their awareness of the “Measures for the Administration of Drug Recall” is low, and the system is mostly a mere formality.
Part 2 Countermeasures For The Production Quality Management Of Traditional Chinese Medicine Decoction Pieces Facing The New Version Of GMP
2.1 Strictly Control The Source Of Raw Material Procurement
Chinese herbal decoction pieces are processed and prepared from Chinese herbal medicines as raw materials, and the planting methods and quality requirements of different types of traditional Chinese medicine raw materials are also different. It can be seen that the quality of Chinese herbal medicines can be effectively controlled only by ensuring the quality of raw materials.
2.1.1 Fixed-Point Directional Procurement To Stabilize The Source Of Medicinal Materials
When purchasing raw materials for decoction pieces, enterprises can adopt a procurement model that combines targeted procurement and bidding procurement in the main raw material production areas, and support the establishment of medicinal material bases and supply bases according to actual needs to ensure that the quality of raw materials is controllable. In addition, a quality audit team composed of multiple departments conducts on-site inspections at suppliers’ supply sites, and conducts on-site audits such as supplier management and quality control management.
2.1.2 Construction Of Standardized Medicinal Planting Bases
In order to effectively ensure the quality of raw materials of Chinese herbal medicines, enterprises can plan to build standardized medicinal planting bases in authentic medicinal material production areas. Carry out planting and management training of medicinal materials, guide growers to complete unified planting management according to requirements, and make records. With the village as the management unit, uniformly distribute chemical fertilizers and seedling subsidies to growers, and do a good job in the publicity of related projects to increase the enthusiasm of growers for planting.
2.2 Promoting The Testing Of All Medicinal Materials
2.2.1 Identify The Authenticity Of Medicinal Materials
When inspecting raw materials, inspectors should strictly refer to relevant international standards and quality control document requirements, as well as the quality clauses stipulated in the contract for inspection. The authenticity of the raw materials of traditional Chinese medicine decoction pieces is directly related to the safety of clinical medication and the therapeutic effect, so inspectors should have rich experience and professional skills to improve the ability to identify raw materials.
2.2.2 Strictly Regulate The Testing Of Medicinal Materials And Control The Safety Indicators
Refer to the relevant standards of the “Chinese Pharmacopoeia” (2015 edition) to improve the self-inspection ability of enterprises for the safety indicators of raw materials of Chinese herbal medicines. Enterprises should timely detect the residual amount of sulfur dioxide on the traditional Chinese medicinal materials and processed decoction pieces that are used to fumigate with sulfur. For the problem of sulfur dioxide residue in raw materials, enterprises should give corresponding technical guidance to farmers during harvesting and processing, scientifically use sulfur fumigation method to process medicinal materials, and control the residue within the national standard. Improve storage conditions, and try to solve the problem of reducing the storage of raw materials after fumigation. Actively carry out research and comparison of detection methods, and study alternative technologies for sulfur fumigation. For raw materials that are easy to add pigments, the HPLC method should be used for detection in time.
2.3 Strengthen The Construction Of Professional Talent Team
2.3.1 Actively Carry Out Master-Apprentice Training And Teaching
The development of enterprises requires a large number of compound talents who not only have the skills of modern instruments and equipment, but also have the ability to identify Chinese medicinal materials, but China’s current education model has not yet achieved this effect. Therefore, enterprises may consider adopting a training mode combining internal training + external invitation. By carrying out the traditional inheritance mode of “teacher-apprentice” within the enterprise, the master is responsible for training newcomers on relevant experience and professional skills, so as to improve the professional talents of the enterprise. ratio, to reserve more talents for the sustainable development of work.
2.3.2 Do A Good Job In Training
Personnel is the first factor affecting quality, so enterprises should conduct GMP training for all employees. In order to effectively ensure the training effect, it is possible to formulate targeted education, training and assessment standards that are in line with the actual situation of the enterprise before training, and strictly stipulate the work standards and professional skills requirements for each position. Training can take the form of out-of-home training, invited experts to give lectures, and internal training at different levels and levels to enhance the staff’s sense of responsibility, legal awareness, and normative awareness, and improve their professional skills and overall management capabilities. Records should be kept during the training process, and the training process of each employee should be recorded after the training is completed, and the training results should be assessed regularly.
2.4 Carry Out Hardware Transformation According To GMP Requirements
Interpret GMP in detail, and after fully understanding the requirements of GMP for enterprise hardware, combined with the actual situation of the enterprise, rectify various hardware facilities that need to be improved according to local conditions. The hardware transformation mainly focuses on two aspects: ① Plants and sites are transformed in accordance with the requirements of the new version of GMP, and unreasonable process layouts are rectified in a timely manner; ② Select equipment and facilities whose design structure and performance meet the requirements of the new version of GMP, and do regular maintenance , maintenance and calibration work to ensure the smooth progress of production.
2.5 Establish And Improve The Construction Of GMP Software System
The GMP software system mainly refers to the standardization of various daily and production-related behaviors, and the establishment and improvement of a targeted and effective GMP file system, covering all links, and refining GMP into the entire production management process. In order to ensure that the quality control management of GMP can be implemented, scientific functional integration should be carried out within the enterprise according to the requirements of GMP, the responsibilities of each department should be clearly defined, and the supervision role of the quality control department should be strengthened. Pay attention to product process verification and cleaning verification to ensure the smooth progress of scientific, standardized and legalized management of living enterprises.
2.6 Strengthen The Management And Control Of The Production Process
GMP aims to avoid the risks of contamination, drug mixing, errors, etc. in the production process to the greatest extent. Therefore, the awareness of production process regulation should be strengthened, the processing procedures of Chinese herbal medicines should be strictly implemented in accordance with the regulations, and the production workshop should be divided strictly according to the production process. Areas, rational layout of various technological processes. Do a good job of recording the original data in a true and timely manner.
2.7 Need The Policy Support Of The National Administrative Supervision Department
In order to promote the pilot process of fixed-point processing of traditional Chinese medicine decoction pieces, enterprises should actively explore the direction of specialized production of varieties and share resources. The government encourages and supports enterprises to establish medicinal material GAP planting bases in accordance with GMP standards, further promote the construction and certification of medicinal material production quality management system, and gradually improve the current quality standard system of traditional Chinese medicine decoction pieces. While strengthening the support for local enterprises, strictly regulate the processing and production operations of enterprises to ensure the safety of people’s medication. Strengthen supervision and management, and increase the investigation and punishment of violations of regulations and illegal production and operation.
Part 3 Conclusion
The issuance and implementation of the new version of GMP has provided a development direction for the standardized operation of Chinese herbal medicine enterprises at this stage, but because it involves the understanding and application of relevant national drug laws and regulations, this puts high demands on the software and hardware of enterprises. Requirements require companies to prepare and respond. Therefore, it is not only necessary for enterprises to manage personnel, hardware and software in a timely manner according to GMP requirements, but also requires the policy support of the national administrative supervision department to implement the normative requirements of the new version of GMP.