Development of Quality Management Concept and Re-understanding of GMP

Good Manufacturing Practice (GMP) is the basic principle of drug production and quality management. It is applicable to the whole process of drug preparation production and the key process in the production of raw materials that affects the quality of finished products. Vigorously promoting drug GMP is to minimize pollution and cross-contamination in the drug production process and reduce the occurrence of various errors. It is an important measure to improve drug quality.

The emergence of drug GMP is inseparable from the development of quality and quality management concepts. From the development of quality and quality management concepts, we can understand GMP from another perspective, and our understanding of GMP may be more in-depth.

The product of the "objective process quality management stage"

Like the development trajectory of other disciplines, people's understanding of quality and quality management is also a process from primitive to modern, from low to high. The earliest human understanding of quality and quality management can be called the "producer's quality management stage". At this stage, whether the product quality meets the standards and whether it is good or bad is determined by the producer based on his own experience, cognition, or with the help of instruments and equipment.

As human society enters the era of industrial civilization, productivity develops rapidly, and the number of products increases dramatically. Producers no longer have the energy and time to judge the quality of products. They can only select a group of specific personnel to specialize in quality and quality management. The "quality management stage of producers" is soon replaced by the "quality management stage of inspectors". Since the selected "inspectors" face different producers and need to coordinate with each other, it is necessary to establish objective product quality standards that conform to the actual situation. As a result, human society has entered the "objective quality management stage" from the "subjective quality management stage", and people's understanding of quality and quality management has taken a big step forward, and the quality of human society's products has been greatly improved.

With the deepening, expansion and popularization of basic mathematical and theoretical research, people have discovered through statistical knowledge and risk assessment theory that the quality of products is produced, not inspected. Moreover, there are great limitations in discovering all product quality problems through inspection, especially for products such as medicines, where each unit of product may have an impact on human life and health. People have found that the control and evaluation of product results should be transformed into the control and evaluation of the production process, that is, the control and evaluation of the entire production quality management system involved in the production of products, that is, the "personnel, hardware, software and work site" involved in production quality management should be controlled and evaluated in an all-round, full-process and full-staff standardized manner. As a result, human society has entered the "process quality management stage" from the "result quality management stage".

With the further improvement of the level of productivity, the professional division of labor in human society has become more and more refined, resulting in more and more frequent trade. In the industrial chain with meticulous division of labor and system, the attention paid to product quality standardization in each link has been unprecedentedly improved, and the standardization requirements for product quality have immediately evolved into "objective" standardization requirements for product production quality systems. In other words, the standards of all elements involved in the enterprise's product production quality system are determined by product demanders, that is, what we usually call customers. When customers believe that the elements of the enterprise's quality system meet their own standards, they can accept the product.

For products related to the national economy and people's livelihood, such as drugs, the government will also establish a statutory "minimum" standard for each element of the product production quality management system, which is the drug GMP. Therefore, human society has entered a new era of quality and quality management, which is the "standardized management era of total quality management", also known as the "objective process quality management stage". For the pharmaceutical industry, the iconic product of this stage is the pharmaceutical GMP.

It is a "means" rather than a "goal"

GMP is the most scientific and optimized method for drug production quality management since the development of human society to date. Of course, with the advancement of human science and technology and productivity, human society will enter a higher and newer stage of product production quality management.

For many years, due to various reasons in the development of my country's social history, especially the subsequent leapfrog development, many concepts and methods of quality management have not been able to keep up with the pace of development of the times. A few domestic pharmaceutical manufacturers are still in the "quality management stage of inspectors". Due to the relatively backward quality management concept, the elements determined by the management system of production quality standardization will be changed from time to time.

GMP is a modern quality management method, the most scientific achievement of human society's understanding of quality and quality management to date, and the best way for pharmaceutical manufacturers to produce high-quality products, ensure product quality and safety, improve productivity, and reduce production costs. However, a few domestic pharmaceutical manufacturers only regard GMP as the "norm" of production behavior that the state requires enterprises to achieve, and mistakenly regard "means" as "goals".

As we all know, the advanced productivity car relies on two wheels, advanced science and technology and advanced management methods. Without any one wheel, the car cannot run normally. The same is true for drug production quality management. If the advanced quality management concept cannot be deeply rooted in the hearts of the people, and the strict GMP system is changed or broken, it is easy to cause unstable drug quality and quality safety problems. This requires drug regulatory departments and regulators at all levels of government to take the lead in establishing advanced quality management concepts, and implement quality management concepts in daily supervision work, strictly supervise, and ensure drug quality and safety.