First, the content and purpose of quality risk management
The purpose of quality risk management. Risk management is a purposeful management activity, and only with clear objectives can it play an effective role. Otherwise, risk management will only become a mere formality, which has no practical significance, let alone evaluate its effect. The purpose of quality risk management is to prevent patients from facing risks in quality, safety and efficacy. Minimize the risk of drug circulation and protect the vital interests of patients. This is completely consistent with the formulation that "drugs are not general commodities, but special commodities related to people's physical and mental health" advocated by pharmacists at ordinary times.
Content of quality risk management. The contents of drug quality risk management are mainly divided into the following three aspects:
Drug safety control. The risk management of drug safety mainly reflects the size of drug side effects and whether patients will have adverse reactions during medication. Preventing safety risks is particularly important for patients. In the stages of drug research and development, manufacturing and circulation marketing, we should pay attention to drug safety, minimize adverse reactions and prevent the harm of drug side effects to patients.
Risk management in drug circulation. The circulation process of drugs includes transportation, storage, distribution and use. This process is a long process that a qualified drug must go through after leaving the factory, and it is an indispensable link in the life cycle of the drug. The risk control in this process is particularly important, which is more complicated than in a pharmaceutical factory.
Risk management of drug efficacy. The curative effect of drugs is one of the most concerned issues for patients. Risk management of drug efficacy is the most basic requirement for drugs. That is, "reliable and effective" can not only cure patients' diseases, achieve the purpose of medication, but also ensure the quality and effect of drugs.
Second, the application of risk management in China's pharmaceutical production enterprises
Enterprise's risk awareness is weak. At present, quality risk management, as a new concept, is still in its infancy in China's pharmaceutical production enterprises. Enterprise risk awareness is generally weak. In China, the risk management of pharmaceutical production enterprises mostly relies on empirical qualitative analysis and intuition. Although some enterprises have set up special risk management departments, most of them exist in name only, which can't guide the work well. Even many enterprises have not set up a special risk management department, lack risk awareness and fail to realize the importance of quality risk management to drug production.
Enterprises lack the resources needed for equipment and fail to implement risk management training. In pharmaceutical production enterprises, enterprises should be equipped with sufficient and qualified factories, equipment, facilities and personnel. At present, many domestic pharmaceutical manufacturers neglect to invest in these basic resources in order to maximize profits. There are no trained and qualified quality risk managers. Operators can't operate correctly in accordance with the operating procedures when conducting quality inspection. The awareness of quality risk management needs to be cultivated as an employee. Lack of training will make employees unable to understand the analytical tools of risk management and hinder enterprises from effectively avoiding risks in the process of production management.
The enterprise has not carried out reasonable risk management. Drug quality risk management runs through all aspects of drug research and development, production, circulation, supply and use. To do a good job in drug quality risk management, enterprises need to carry out reasonable risk management in every link. At present, most enterprises in China rely on the personal experience of managers in a certain procedure to judge risks. In the process of quality risk management, the person in charge of quality management and the person in charge of production management have part-time jobs.
Third, the direction of drug quality risk management.
Improve infrastructure construction. Enterprises need to increase investment in infrastructure and improve the required resources. First of all, pharmaceutical production enterprises should have a clean production environment; The ground, road surface and transportation of the factory should not cause pollution to drug production. The workshop should be properly maintained on a regular basis, and necessary cleaning or disinfection should be carried out according to detailed written operating procedures. Secondly, the quality control laboratory should be separated from the production area. The design of the laboratory should ensure its intended use and avoid confusion and cross-contamination. Laboratories handling biological samples or radioactive special articles shall meet the relevant requirements of the state. When necessary, a special instrument room should be set up to protect high-sensitivity instruments from static electricity, vibration, humidity or other external factors. Finally, in terms of design and installation, it is necessary to equip weighing instruments, measuring tools and instruments with appropriate range and accuracy. It is also necessary to select appropriate cleaning and cleaning equipment and prevent such equipment from becoming a pollution source.
Enterprises should strengthen risk awareness and do a good job in risk assessment. Quality risk management is a systematic process, which is used to coordinate, promote and improve risk decision-making based on science. Enterprises should summarize, summarize, analyze and summarize the experience and lessons of quality risks, strengthen the awareness of quality risks of enterprise managers and employees, and strengthen the concern, attention, prevention and suggestions of all employees of enterprises. Do a good job in risk assessment, including hazard identification, analysis and assessment of hazard-related risks. The system needs to use this information to identify and discover the potential sources of risk problems. We must also do a good job in quality risk forward management and quality risk traceability management.
Establish a reasonable management organization and strengthen staff training. First of all, enterprises need to establish an independent quality management department to perform the duties of quality control and quality assurance. The quality management department shall participate in quality-related activities and be responsible for reviewing all documents related to this specification. It is necessary to clarify the responsibilities of each department and post, and assign responsibilities to each department or even everyone in strict accordance with the procedures.
Secondly, enterprises need to clarify the respective responsibilities of "key personnel", "enterprise responsible personnel" and "production management responsible person". Key personnel should be full-time staff of the enterprise, including at least the person in charge of the enterprise, the person in charge of quality management, the person in charge of quality authorization and the person in charge of production management. It is necessary to strictly put an end to the phenomenon that the person in charge of quality management and the person in charge of production management are concurrently responsible for each other. It is also necessary to formulate operating procedures to ensure that the quality authorization can perform its duties independently without interference from enterprises and other personnel. It should be clear that the person in charge of the enterprise is the main person in charge of drug quality and is fully responsible for the daily management of the enterprise. In order to ensure the enterprise to achieve the quality objectives, the person in charge of the enterprise should provide the necessary resources and make a reasonable plan to ensure that the quality management department can perform its duties independently. The person in charge of production management shall have at least a bachelor's degree in this major or related field, at least three years of practical experience in drug production and quality management, including at least one year of experience in drug production management, and have received professional knowledge training related to the products produced.
Thirdly, enterprises should let departments or professionals be responsible for employee training after clarifying the responsibilities of internal personnel. You can't do blind training during training, and the content of training should adapt to the requirements of the post. In addition to the theoretical and practical training specified in this regulation, training on relevant laws and regulations, responsibilities and skills of corresponding posts should be conducted, and the actual effect of training should be evaluated regularly to ensure the effectiveness of training and fundamentally improve the working ability and efficiency of employees.
The application of the concept of quality risk will help enterprises to shift their focus to the key points to ensure the quality of drugs and produce qualified drugs. At present, the ability of Chinese pharmaceutical manufacturers to manage drug quality risks is relatively low. This requires enterprises to do a good job in the quality management of every link in the pharmaceutical production process. Continuously improve the quality of employees and enhance the awareness of quality risk management. Using scientific methods and the experience of pharmaceutical manufacturers, we can master the quality of drugs, predict risks and standardize production. Improve the level and ability of enterprises to resist quality risks, reduce the incidence of quality risks, minimize the harm of drug quality defects to patients, and produce quality-controllable, safe and effective drugs for the people.