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　　[Quality Control]

　　Adhere to "doing medicine with heart" to improve the quality of medicines

In order to further prevent the quality of drug production risks, improve the implementation of GMP levels in pharmaceutical production enterprises, reduce the quality and safety risks of drugs from the source, improve the quality of drug production, and ensure the safety and effectiveness of public drug use. As a pharmaceutical manufacturer, it must follow: to reduce and avoid human error through the monitoring of the pharmaceutical production process; to prevent drug contamination and quality degradation through standardized operations; to continue through a sound, operational quality assurance system Improve and improve these three principles.

As we all know, product quality is the result of production activities of enterprises, and product quality is formed in the production process. Therefore, the company should be the first person responsible for product quality. To ensure the quality of drugs, pharmaceutical manufacturers must strengthen their own management and improve product quality.

First, we should enhance quality awareness and responsibility

To ensure the quality of drugs, we should first enhance the quality awareness, because quality is the life of the enterprise, the carrier of the corporate culture, and the cornerstone of the survival and development of the enterprise. Guaranteeing the quality of drugs is the conscious requirement for the production and development of pharmaceutical manufacturers, and it is also a mandatory requirement for enterprises such as the Drug Administration Law and the Product Quality Law. Therefore, as a pharmaceutical manufacturer, in order to survive and develop in the market competition, we must pay close attention to product quality, carefully abide by drug safety laws and regulations in the production process, strictly implement the "Good Manufacturing Practices" and drug quality standards, and have excellent quality. The products are the weapon that the enterprise is surprisingly successful in the business war, and the enterprise can be in an advantage in the market competition.

Second, strengthen supervision and control of the production process

As a pharmaceutical manufacturer, it should be fully understood that the quality of the drug is designed and produced, not the profound connotation of the test. Quality management activities must be carried out throughout the production process to achieve products that meet established quality standards. Pharmaceutical production is a complex process. From the entry of raw materials to the production of pharmaceuticals and inspection and release, design to many processes and links, quality must be ensured in every link, in order to ultimately guarantee product quality. Reduce errors and pollution in the production process through full participation and effective prevention, thus reducing the occurrence of quality accidents.

Third, improve the quality management system

The system provides basic guarantees for ensuring and improving the quality of medicines. The various softwares established must meet the requirements of industry norms, and must conform to the actual situation of the enterprise and be operable. The quality of products should be based on standards, accurate measurement and strict supervision. The various systems should be effectively implemented and continuously revised and improved during the implementation process; otherwise, the re-improved system will be shelved, become a piece of paper, cannot be effectively implemented, and the production process will not be effectively monitored, and product quality will ultimately not be guaranteed. .

Fourth, strengthen the construction and management of the talent team

Enterprises need more than one or two talents who are proficient in drug MGP at key locations, but the quality of the overall practitioners, so as to ensure quality risk control throughout the process.

　　Quality Supervision and Management Department: Yang Wenjun

　　Strengthening the responsibility and strict quality control

If pharmaceutical companies want to survive and develop in the fierce market competition, they must strengthen the quality management of pharmaceutical production and improve product quality. It can be said that product quality is the life of an enterprise. Producing first-class quality products and establishing a good quality image of enterprise products should be the eternal theme of enterprise development under any circumstances.

Pharmaceutical companies must have a comprehensive design and implementation system that integrates quality management practices, quality control, quality assurance systems, and quality management systems for quality risk management. Only by strengthening the quality management of pharmaceutical production, improving product quality, exploiting the market with quality, and consolidating the market with quality, can we achieve substantial profits and greater economic benefits.

IBM Management School has such a famous saying: "Quality = 90% attitude + 10% knowledge." The implication is that the overall improvement of product quality depends on advanced science and technology and testing equipment, but mainly in production. Process and employee's high sense of responsibility and quality awareness and work attitude. In other words, the key to product quality is “people”. Regardless of the circumstances and premise, the human factor is the first. Man is the main body of the governing machine, and the person decides the quality, not the machine determines the quality.

Quality is the cultivation of a sense of responsibility of people. Each of us must do our own job and combine to ensure the quality of the entire product. When work is tied to responsibility, our work has practical meaning. When a position is linked to a responsibility, responsibility is stress and more motivation. The production process and quality control of the products are interlocking. Every subtle link needs serious and dedication. If it is slightly careless, it may cause quality hazards. Therefore, we need to strengthen the responsibility of work from the following points, to prevent the emergence of substandard products, so as to achieve the ultimate goal of comprehensive improvement of product quality.

First, training and education on quality basics should be strengthened. People play a decisive role in quality management. Their quality and business ability are directly related to the quality of products and the rise and fall of enterprises. Therefore, continuous training and education for employees is required. Training and education should be guided by market demand. Various forms can be used to strengthen the training of all staff skills. Efforts should be made to improve the quality awareness of employees and to arm all employees with modern quality concepts and quality management methods.

Second, we should focus on the details to improve quality. Pursuing perfect quality requires starting with small things, making details, and determining the success or failure. Taishan does not refuse the fine soil, so it can become its high; the river does not choose a trickle, so it can be deep. The details are the essentials of the process, and the quality is mastered by mastering the details. As the social division of labor becomes more and more detailed and the degree of specialization becomes higher and higher, detail management is particularly important. Pay attention to the details, and strive for quality to ensure that the product wins in the competition. Therefore, the pursuit of perfect quality, grasping the details is the focus of quality.

Finally, we must standardize the quality behavior of all employees. In modern production, as long as one person's quality behavior is not standardized in new technology and high-level products, it will cause hidden quality problems. Therefore, only by first regulating the quality behavior of people and vigorously improving the quality of people can the output of qualified products be guaranteed. We must deal with the relationship between quality awareness and quality behavior in our daily work. In addition to strengthening the quality awareness education of all employees, we must also implement quality awareness into the standard quality behavior. We only want to have good quality, but we must know how to do it to ensure that the products are 100% excellent. We not only know how to do it, but also The meticulous implementation of the action ensures that every quality behavior is not out of shape, so as to ensure that the products produced are 100% excellent.

As a member of Kyushu, I should take Kyushu as my home. First of all, I should start from the self, be strict with myself in work, improve the quality of work and work efficiency, always remember to strengthen the sense of responsibility and strictly control the quality. At the same time, I also hope that every employee of the company can regard the responsibility as Taishan, depending on the product in the hands, depending on the quality in the heart, the details are improving, so that the idea that "quality is the life of the enterprise" is integrated into the mind and mind. In our work, we will contribute to the future of Kyushu.

　　Technical Department: Li Keyu

　　How to improve the quality of medicines

　　---Analysis of people, machines, materials, methods, and rings

The quality of medicines is the life of an enterprise, and it is more about the safety of patients' medications. Therefore, it is our unshirkable responsibility to improve the quality of medicines.

How to improve the quality of medicines? We believe that we should analyze the five aspects of the quality of drugs affected by people, machines, materials, laws and rings.

Person, refers to the person who manufactures the drug; machine refers to the equipment used to manufacture the drug; material refers to the raw material used in the manufacture of the drug; law refers to the method used to manufacture the drug; ring refers to the environment in which the drug is manufactured.

Among the five major elemental theories, people are in a central position and driving position. Just like a moving car, the four wheels of a car are the four elements of "machine", "material", "law" and "ring". The elements of this "person" are the main ones. Without the driver, the car would only be left in the waste. Similarly, if a factory has good methods for machines, materials, and processed products, and the surrounding environment is suitable for production, if the factory does not have employees, then it is still impossible to produce.

Human analysis: 1. Does the qualification meet the requirements? 2. Is your health healthy? 3. Is the number of personnel sufficient? 4. Is the training? 5. Can I be qualified for work? 6. Is the character good? 7. Is there a sense of responsibility? Machine analysis: 1. Is the selection correct? 2. Is it verified? 3. Is it running normally? 4. Is it regularly maintained and maintained? 5. Is the operating procedure applicable? 6. Is the environment suitable for placement? Analysis of materials: 1. Is it a fixed point purchase? 2. Is there an inspection report form? 3. Acceptance and warehousing according to regulations? 4. Have you checked according to the regulations? 5. Does the material storage environment meet the requirements? 6. Is the distribution and use in compliance with the specifications? Analysis of the law: 1. Is there a law? 2. Is the law suitable? 3. Is it done according to the law? 4. Remember what you have done? ; Analysis of the ring: 1. Does the temperature meet the requirements? 2. Does the humidity meet the requirements? 3. Does the illuminance meet the requirements? 4. Does the air cleanliness of the fine, dry and package workshop meet the requirements? 5. Is there any smell? 6. Is there dust? 7. Is the exhaust device turned on? 8. Are the placement of various products, raw materials, tools and personal items in compliance with the requirements?

In summary, as long as we do a good job in the five aspects of people, machines, materials, law, and ring, we will ensure and improve the quality of drugs.

　　Synthetic workshop: lou cong liang

　　[Short comment]

　　Quality management of pharmaceutical production is always on the road

At present, the company actively responds to the call of the “Quality and Safety Improvement Year” of the higher level, and has formulated the implementation plan for the quality management of pharmaceutical production. In order to achieve the results of the quality improvement activities, the quality supervision department of the company has proposed the quality management of pharmaceutical production from four aspects. Sixteen specific requirements. The urgent task now is to combine the actual situation of the workshop and the department, and arrange the work in each work position according to the production quality management work arrangement.

Enterprise management is an eternal theme, and the quality management of pharmaceutical companies is no exception. Regardless of how the way the company manages changes, it is inseparable from the specific post operations of employees to achieve management purposes. In a word, quality management is to grasp the management of employees, and employees have the responsibility to produce qualified products. Improving the quality of production can not only rely on good technology and advanced equipment, human factors play a big role. The experience of our company in producing quality management and quality certification for many years fully proves that the quality of production is not only produced according to the regulations of medicines, but also not by technical equipment. These are just an indispensable part of the quality of production. The core element of ensuring production quality management is that our company's production line employees do it little by little. Therefore, to improve production quality management, we must finally implement the quality concept into the hearts of every working producer and put the requirements of the regulations into the hands of every working producer.

There is no end to quality management, and improving production quality is always on the road. To make the production quality management well, every detail should be flawless. As long as you carefully compare each specific requirement in the production quality management work, you can see the importance of grasping the details. For example, a figure in an employee's production record, a cleaning container action, seems simple, but closely related to quality. Therefore, to improve production quality management, we must always implement the quality concept. Employees often have a sense of responsibility and product quality is guaranteed.

　　Supervision Office: Li Zhiping

　　[Management field]

　　Active self-checking and fruiting workshop to produce compliant flowers

In order to ensure the actual results of the “Quality and Safety Improvement Year” activities carried out by the company this year, on the basis of the comprehensive staff skill operation level assessment training, the injection workshop is in accordance with the overall requirements of GMP and the pharmaceutical production quality work arrangements proposed by the company's quality supervision department. Actively carry out self-inspection activities, improve the staff's quality awareness and post operation skills, and promote the production quality management ability of the workshop.

The self-inspection activity carried out by the injection workshop can achieve practical results. First, the workshop leaders carefully organize and take the lead. The director, the squad leader and the craftsman form a self-inspection team. Every day at 4 pm, the self-test summary is summarized and a self-test is issued. Announcement, rewards and penalties, spurs and progress. Secondly, the self-inspection activities are closely integrated and integrated with the employee operation skill level assessment training content. This change in the form of production quality management mobilizes the enthusiasm of employees to participate actively. The automation of the needle packaging line in the workshop is high. In the past, the production line often heard the sound of “stop! stop! stop!”, and now only the machine makes a cheerful sound. In the past, the steel nails on the box machine were replaced, and it took more than 40 minutes each time. Now it takes only 5 minutes for the staff to complete the replacement.

　　Injection workshop: Wang Xiuli