CDE Expert | Analysis and Countermeasures of Drug R&D Quality Management System
Abstract: drug R&D involves a wide range of projects, multiple fields and disciplines, with long R&D cycle, large investment amount and significant complexity. During drug R&D, the listing license holder shall formulate the management system and design the drug test plan according to the actual situation of the enterprise, strictly abide by the system and carry out the test according to the test plan, Truthfully record the experimental data to ensure the authenticity, accuracy and integrity of the application data. In this process, the quality management system is the key. The management level of drug R&D quality has a direct impact on the final quality of drugs. This paper mainly analyzes and discusses the characteristics of drug R&D and summarizes the measures to improve the quality management of drug R&D.
In recent years, Chinese medicine has gradually shown the trend of overall rapid development. There is still an obvious gap between Chinese pharmaceutical enterprises and foreign pharmaceutical enterprises in terms of drug R&D and investment. With the continuous improvement of domestic economic development level, people's quality requirements for pharmaceutical products are also gradually improving. At present, the R&D investment level of China's pharmaceutical industry is still relatively low, and the R&D investment of many large pharmaceutical enterprises is not enough. Therefore, how to make use of R&D investment and give full play to the basic role of pharmaceutical enterprises belongs to the key issues concerned by pharmaceutical enterprises. The quality management of pharmaceutical enterprises, especially during drug R&D, is directly related to drug safety and quality. From the perspective of pharmaceutical enterprises, a scientific and comprehensive quality management model in the process of drug R&D has a great impact on the safety and quality management of R&D drugs, and plays a promoting role in drug R&D and production, The official account is helpful to give full play to the social value of enterprises. We will analyze the quality management system of drug research and development and summarize the specific measures to deal with it. The specific research contents will be summarized as follows.
1. Characteristics of drug R&D
At present, the key content of drug quality management in China mainly lies in production and operation management control. At this stage, there is still a lack of normative guidance documents on drug R&D. As one of the basic innovation projects of the system, drug R&D involves many fields and disciplines. In the process of drug R&D, a variety of new technologies will be applied and can be carried out according to different processes. Its R&D characteristics are mainly characterized by high quality requirements, heavy workload and long R&D cycle. The purpose of R&D is to improve drug performance through continuous experiments, Promote the drugs to be put into the market as soon as possible after being approved to meet the actual consumption demand as much as possible [1].
1.1 large investment and high risk
New drug R&D needs a lot of money and time. This phenomenon has reached a consensus in the pharmaceutical industry. The market return obtained after investing a lot of money and time will also face uncertainty due to the influence of many factors. Therefore, there is a mismatch between new drug R&D and input and output.
1.2 the emergence of a large number of generic drugs
Due to the uncertainty of new drug R&D, market risks and R&D investment can be comprehensively considered. Most pharmaceutical enterprises have gradually changed their R&D direction to imitate foreign successful drugs. According to relevant research data, in 2015, there were only 59 new drugs listed in China, but more than 150 generic drugs. Therefore, it is necessary to further improve the R&D quality of domestic innovative drugs [2].
1.3 the new drug approval system is relatively strict
With the improvement of China's drug management level, the national approval requirements for pharmaceutical enterprises' products have gradually increased. According to the relevant data of China's drug approval report, China applied for more than 8000 drugs in 2015, but less than 400 drugs were approved for listing, with a passing rate of only 5%. With the continuous improvement of the standardization of pharmaceutical products, The drug approval system is becoming more and more strict, so the requirements for R&D quality management of pharmaceutical enterprises are becoming higher and higher [3].
2 problems existing in drug R&D of pharmaceutical enterprises
2.1 it is difficult for R&D institutions to meet the needs
There are many projects and disciplines involved in drug R&D and a relatively wide range of fields involved. Therefore, the characteristics of long cycle, high technical difficulty and large investment are highlighted in the operation process. The difficulty of drug R&D will also change around the different classification of registration application, and there are many influencing factors of R&D projects, Therefore, there are different types of problems in the R&D process. The whole process of drug R&D is jointly participated by multiple departments, including quality, R&D, production, engineering design, storage and procurement. It is easy to cause the problem of insufficient cooperation among various departments, resulting in the decline of R&D efficiency. In the initial stage of drug R&D, it is not necessary to carry out relevant operations step by step in accordance with GMP. With the progress of R&D process, after pilot scale-up, all drug R&D links need to operate under the drug production quality management standard system, This shows that if the technology transfer process is short, the lack of R&D quality official account and the overall quality management may increase the risk of data traceability.
2.2 imperfect R&D quality management system
At present, there are mainly two ways in drug R&D in China. One is that the drug marketing license holder has a fixed R&D team, which is responsible for drug development, application for registration and other related projects, and the other is to entrust the drug R&D projects to other R&D institutions, The drug marketing license holder shall closely monitor the quality problems in the process of drug R&D, and be responsible for the review of final application materials and registration of R&D projects. If there is a lack of sound quality management system during drug R&D, a lack of comprehensive management of the documents and experimental records used during R&D, and the original records are not kept in place, there may also be adverse phenomena such as missing records during data sorting, which will eventually make it difficult to control the logic and integrity of the whole registration data. On the other hand, inadequate management of R&D personnel may also lead to the risk of disclosure of intellectual property rights and key technologies.
2.3 lack of total quality management methods and tools
Total quality management methods and tools are rarely used in the quality management of R&D projects. For example, the effect of applying PDCA management measures in the process of drug R&D has not reached the expected goal. The specific reason is that this management mode has not fully participated in any link of drug R&D during the application period and has not established a continuous Effective process, so there are often loopholes and deficiencies in specific practice. However, even if there are some defects and deficiencies during the application of PDCA management mode, through in-depth analysis and correction, and then the improvement of preventive measures, the quality of the whole drug R&D project can be further improved, and even the effect of reducing the actual cost of the project can be achieved.
2.4 the risk management mode has not been effectively implemented
Risk events are essential in the practice of R&D projects. The difference only lies in the different types and sizes of risks. The risks in drug R&D projects are mainly reflected in competition risks, talent, market and financial risks. The main risk problems in the outsourcing process of R&D projects are mainly reflected in project risks, contract risks and outsourcing management risks. When selecting outsourcing companies, their R&D technical ability Project management capability is an important assessment content for the company to complete the outsourced R&D tasks on time when executing the contract. Once the outsourcing company has insufficient project R&D capability or poor project management, it will affect the R&D project results [4].
3 countermeasures to improve the quality management system of drug R&D
3.1 strengthen R&D personnel training
Most enterprise R&D personnel pay more attention to technology, their own quality system awareness is poor, and their cost awareness is weak. Due to the nature of R&D work, they may encounter different types of accidents during work. In the face of such situations, it is necessary to further strengthen the professional training of R&D personnel in the drug life cycle in the process of quality management, and continuously strengthen the quality awareness of R&D personnel through training.
3.2 realize the standardization and process of working mode
Standardization refers to the formulation and implementation of standards for repetitive things and related concepts in social practice, in order to obtain the best social benefits after reaching the unified standards. In the process of drug research and development, based on the requirements of the quality management system and in combination with the characteristics of the enterprise, the specific activity contents are formulated in the form of documents and specific processes to realize standardization, This is of positive significance to ensure the final quality of R&D products. It can not only reduce enterprise management costs, but also improve R&D efficiency [5].
3.3 improve the quality management system
The concept of ISO quality management system is introduced in the drug R&D process to supplement and improve the deficiencies of drug production quality management norms, and then improve the implementation after improving the existing laws and regulations. In addition, through the application of the quality management system model of the International Coordinating Council on technical requirements for human drugs, we can create unique laws and regulations suitable for China's national conditions, use the "four strictest" to restrict the behavior of drug enterprises that do harm to people's health regardless of product quality, and require drug enterprises to fulfill the responsibilities of the listing license holder, Bear legal consequences and criminal responsibility [6]. In the R&D process, after the completion of phased projects, it is necessary to timely implement evaluation measures and review from technology, quality and other aspects to ensure the stable implementation of the project. For the projects that need to be changed, it is also necessary to establish a quality improvement mode to ensure the traceability of the changed projects. In addition, after the completion of the project, the comprehensive analysis of drug R&D is more important, and timely implement data declaration Industrialization support and archives management are of positive significance to improve the quality of drug development.
3.4 improve the concept of drug quality supervision
The main measures to be taken by drug R&D and production enterprises are to strengthen the publicity of drug quality and safety and encourage people to actively participate in drug quality supervision, which can promote the top leaders of drug enterprises, operators and R&D personnel to have rich awareness of drug life cycle quality management, and implement management procedures from marketing use, drug R&D and production [7].
3.5 improve the risk assessment mechanism of drug life cycle quality
During drug research and development, the control of quality risk management principles plays a key role. In the process of quality risk assessment, professional scientific knowledge is used as the baseline, which is related to the protection of patients, comprehensively evaluate the safety risks of all links in the drug life cycle, and immediately communicate with management personnel after understanding the risk degree, so as to take risk control measures as soon as possible and nip in the bud.
3.6 strengthen quality risk management
The risk of new drug R&D is relatively high. If there is improper treatment in the R&D process, it is easy to cause R&D failure. Therefore, the main problem of drug R&D quality management lies in risk management. Through effective risk management measures, the problems existing in the drug R&D process can be found in time, controlled and solved in time, so as to help enterprises make risk decisions scientifically [8]. In the R&D process, scientific process is also required to manage the product process from R&D to product approval. In addition, ensuring the integrity of data in the R&D process is also an important method to ensure drug quality. Establishing a perfect management mechanism, carrying out scientific management of original records, and strictly implementing monitoring and audit in the test process can ensure the scientificity and effectiveness of data.
3.7 establish a correct awareness of drug R&D management
Drug R&D is closely related to the development of medical undertakings, and it is also related to people's life safety. Based on this, relevant departments need to strengthen publicity and education and formulate mandatory measures, so as to improve the attention of drug manufacturers and quality managers to drug R&D, further improve the quality management level and ensure the final production quality of drugs. In addition, the relevant departments need to establish professional quality management teams, select professional quality management personnel to take charge of the whole drug research and development process, strengthen official account management in the process of development, and establish independent departments under the conditions permit, monitor and manage the drug research and development process in a comprehensive way, and ensure the quality of research and development.
4 Summary
Drug research and development is a systematic and comprehensive project, which has certain uncertainty in the process of practice. In the process of R&D, if the initial stage is not carried out in accordance with the quality management system, it is difficult to carry out all links in the later stage in accordance with the quality management system. Therefore, if the quality management is not carried out throughout, the data traceability and reliability can be affected, and then the R&D risk can be increased [9]. Therefore, an effective quality management system can reduce the risk of R&D and is of positive significance to ensure the safety of public medication.
