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The International Organization for Standardization (ISO) recently summarized the scientific theories and experiences of modern social quality management, and proposed eight quality management principles as the basis of the revised ISO9000:2000 series quality management system. China has adopted the ISO9000 family 2000 version of the international standard. In fact, these eight quality management principles have been applied in the implementation of GMP. The difference is that the ISO9000 family standard 2000 version systematically summarizes the eight quality management principles and rises to the height of the theoretical system. Knowing it and applying it will further enrich the foundation of the company's quality management system, consolidate and innovate the results of implementing GMP.
The customer-centered customer-centric principle is the first principle of the eight quality management principles proposed by the 2000 edition of the ISO9000 international standard. Drugs are special products that are related to human life safety. It is also necessary to recognize the special needs of customers for drug demand and to strengthen the GMP awareness and quality awareness of all employees. A typical example is the failure of the former Federal Republic of Germany Grennansu Pharmaceutical Factory to “close to the biggest drug disaster of the 20th century†due to the production of teratogenic reaction-stopping tablets.
At present, the most urgent task for pharmaceutical companies is to pass GMP certification. GMP certification is a state power organ that reflects the will of the people. Whether the pharmaceutical factory can provide supervision and inspection measures for drugs that meet the requirements of GMP. Only by implementing GMP and passing the certification can we show that pharmaceutical companies have a minimum "customer-centric" corporate philosophy, otherwise they will be eliminated by the times.
The role of the leadership of the pharmaceutical company's product quality is a comprehensive reflection of all aspects of the company's work (including the implementation of GMP), related to the survival and development of enterprises. The top management of the enterprise must be responsible for the formulation and implementation of the quality policy, and establish the purpose and direction of organizational unity. Article 4 of China's GMP (Revised in 1998) requires that the person in charge of the enterprise must have a college degree or above in medicine or related majors, have experience in drug production and quality management, and be responsible for the implementation of GMP and product quality. It is the responsibility of the top leader of pharmaceutical companies to be able to implement GMP, establish rules and regulations, and form a corporate culture of their own unique style.
The participation of the three full members in China's GMP has made demands on personnel at all levels. GMP training for all levels of personnel is a necessary process. In essence, GMP is the specific application of Total Quality Management (TQM) in pharmaceutical companies that reflects “full participation, full participation†and “full participationâ€. In the quality management principle, “full participation†not only reflects the “people-oriented†management thinking, but also embodies the incentives and training of employees, the development of human resources, and strengthens GMP awareness among employees, and has a sense of responsibility for their performance. Participate in the continuous improvement of participating companies. The GMP document stipulates the standard operating procedures (SOP) for employees, and the personal responsibility system is linked with the quality of the company's products, which will promote the improvement of TQM and GMP levels, which will improve the quality of the company's products. .
Four process method
The 2000 version of the ISO 9000 family of international standards specifically emphasizes the process approach in quality management principles. Any activity or set of activities that use resources to convert input to output can be considered a process. In order for an organization to act effectively, many interrelated and interacting processes must be identified and managed. Usually, the output of one process will go directly to the input of the next process. The process of systematically identifying and managing applications within an organization, and in particular the interaction between these processes, is referred to as a "process approach." Among the GMP elements of pharmaceutical companies, there are many processes and key activities that can be systematically identified within and between functions of the organization. China's pharmaceutical companies should implement the verifications required by GMP in a planned and comprehensive manner.
Five Management System Approach The core content of the pharmaceutical enterprise quality management system is GMP. In other words, GMP reflects the soul of the pharmaceutical enterprise quality management system. The country has passed GMP certification and confirmed whether the pharmaceutical company has established a quality management system. Pharmaceutical companies construct such a system that can achieve the organization's quality goals in the most efficient way. There are many associated processes within the system, and the systematic approach to application management to identify it, understand it, and manage it can enable stakeholders to build confidence in the organization's coordination, effectiveness, and efficiency. Of course, the management system within a pharmaceutical company can include several different management systems, such as a quality management system, an environmental management system, and a financial management system, all of which can apply a systematic approach to management, all of which are closely related to the quality of the company's products.
Six continuous improvement of pharmaceutical companies to continuously improve products, processes and systems as the goal of each member of the organization. A common feature of the World Health Organization (WHO) GMP and national GMP is that GMP only specifies the required objectives and does not list solutions to how to achieve them. This is to provide employees with continuous improvement methods and tools to train, consistently improve the performance of the organization in the organization, to survive by quality, to benefit from management.
Seven fact-based decision-making methods One of the effectiveness of the pharmaceutical enterprise quality management system is reflected in the accuracy of the data and the smooth flow of information. Make sure your data and information are fully reliable and analyze the data and information in the right way. Make decisions and take action based on analysis of facts, plus experience and intuition. Such decisions are informative decisions that enhance the ability to demonstrate the effectiveness of past decisions by reference to actual records, and enhance the ability of opinions and decisions to be reviewed, challenged, and changed. The key to the development of pharmaceutical companies is decision-making, which is the basis of rational behavior. Pharmaceutical companies must have clear goals in their decisions, one of which is the high quality of medicines. In addition to management decisions (such as quality veto power stipulated by GMP) and business decisions (such as determining the target market for sales), it is important for strategic decisions, such as mergers and acquisitions, to develop a new drug and research institute, and universities. Development and so on.
Eight mutually beneficial supplier relations Article 76 of China's GMP stipulates: “The quality management department shall, in conjunction with relevant departments, evaluate the quality system of major material suppliers.†The quality system assessment or review is used as a link to establish short-term gains. And the long-term balance of interests based on the interrelationship, sharing experiences and resources with partners, sharing information and planning for the future, can optimize costs and resources, and make flexible and rapid response to changes in market or customer needs and expectations. To enhance the ability of both parties to create value.
In short, in the face of the development of the socialist market economy, China's pharmaceutical companies should apply the above-mentioned quality management principles to the implementation of GMP in the face of their own actual situation, and establish the quality management system of the enterprise. Foundation. At the same time, establish a modern enterprise system, form a scale economy, strengthen the research and development of new drugs, strengthen scientific management, to obtain the best economic and social benefits, thereby enhancing the competitiveness of China's pharmaceutical products in the domestic and foreign markets.
How to manage your business in accordance with the new GMP standards
GMP is a science of dynamic and development. GMP continuously absorbs the new theories and practices of quality management in its development process, applying new technologies and processes in the fields of biological sciences, microelectronics and new materials science to humans. Medicines that provide safe, effective, uniform, stable and timely treatment for disease prevention and health promotion.