The 3 stages of development of pharmaceutical GMP

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This paper focuses on the emergence and development of pharmaceutical GMP and introduces the 3 stages of pharmaceutical quality control. Since drugs are special commodities that are related to human life, strict quality control of drug production is implemented in all countries of the world. GMP is the English term for “Good Manufacturing Practice for Drugs” or “Good Practice in the Manufacture and Quality Control of Drugs”. GMP is the abbreviation of “Good Manufacturing Practice for Drugs” or “Good Practice in the Manufacture and Quality Control of Drugs”, which is translated as “Good Manufacturing Practice for Drugs” or “Good Practice in the Manufacture and Quality Control of Drugs”. In China, it is referred to as GMP for drugs.

Quality inspection stage

Initially, the understanding of quality management was limited to the inspection of quality. The means used for quality inspection were various kinds of testing equipment and instruments, and it was done in a strict way, with 100% inspection. The book “Principles of Scientific Management” represents the requirement for the scientific division of labor among personnel, so the responsibility of performing quality management is transferred from the operator to the foreman, and some people call it “foreman’s quality management”. Most enterprises have set up a full-time inspection department and led by the plant manager, responsible for the whole plant production units and product inspection, some people call it “inspector of quality management”. Quality inspectors from the production of finished products (such as large infusion, and water injection) pick out the scrap, to ensure the quality of the factory products. However, this “after-the-fact inspection and gate-keeping” can not play a preventive and control role in the production process, the scrap has become a fact, the loss can not be recovered, and, 100% of the inspection is extensive, resource-intensive, increasing costs, not conducive to productivity improvements. For some products, the inspection is destructive inspection, the inspection of a damaged one, the full number of inspections simply does not work.

Statistical quality control stage

As early as the 1920s, some statisticians and quality management experts noticed the weaknesses of quality inspection, and try to use the principles of mathematical statistics to solve these problems. 1924, the U.S. Bell Labs engineers put forward the concept of control and prevention of defects, and the application of probability theory and mathematical statistics theory, the invention of an operable “quality control chart “. This new method solved the shortage of quality inspection after the fact. 1929 Bell Labs proposed the principle of statistical sampling inspection and sampling inspection table, which solved the difficulties in the application of full number inspection and destructive inspection. Quality management has shifted from the nature of the end gatekeeper after the fact to the control of the production process; from eliminating non-conforming products through inspection to preventing non-conforming products. Whether it is the sampling inspection of products or the quality control of the production process, statistical thinking methods and statistical analysis methods are widely used. However, due to the overemphasis on the statistical methods of quality control, while ignoring the organization, planning, management, and other work, people mistakenly believe that “quality management is mathematical and statistical methods”, “quality management is a matter of statistical experts”, which to a certain extent limits the statistical This to a certain extent limits the promotion of the use of statistical quality control methods.

Total quality management stage

In the second half of the 20th century, the rapid development of social productivity, the rapid changes in science and technology, higher quality requirements for products, increased competition in the market, and the increasing attention of enterprises in various countries to product responsibility and quality assurance issues. Under such circumstances, it is difficult to ensure and improve quality by relying only on quality inspection and the use of statistical methods, and it is obviously inappropriate to leave the quality function entirely to specialized quality control engineers and technicians. Therefore, many companies have started the practice of total quality management. The first to introduce the concept of total quality management is the American General Electric Company, total quality management is to be able to market research, design, production, and service at the most economical level and take into account the conditions to fully meet the requirements of users. In the book Total Quality Management, it was emphasized that “the implementation of the quality function is the responsibility of all personnel in the company, and all personnel in the company should be made aware of and responsible for quality”. Since then, the concept of total quality management has been gradually accepted by countries all over the world, and quality management experts and scholars from various countries have formed a whole set of theories and methods of total quality management based on statistical quality control (SQC) and widely absorbing the theories of various modern disciplines, combining technical management, administrative management, and modern business management methods. GMP was developed in this process.

In 1967, during the 20th World Health Assembly, the World Health Organization (WHO) organized the drafting of the “Good Manufacturing Practice for Pharmaceuticals” (draft), which was revised by an expert committee and published in 1969. WHO-GMP was revised in 1992, and WHO-GMP was published again in 1997 as a supplement to the 2nd edition of the International Pharmacopoeia. Now in its 2009 edition, Chapter 5 “Hazard and Risk Analysis in the Pharmaceutical Industry” recommends the HACCP risk management approach.

Throughout the international development of GMP, countries have gone through two stages of development. The first one is the stage of understanding, accepting, and implementing the new scientific management system of GMP; the second one is the stage of maturing GMP, based on the established GMP system, introducing new technologies and concepts of science and technology and management, such as the application of electronic computers. During the long-term practice of pharmaceutical production, people’s understanding of the means of quality assurance is gradually deepened and the content of GMP is constantly updated and progressed.


GMP is a legal standard for the supervision and management of the whole production process of pharmaceuticals, which is a reliable measure to ensure the quality of pharmaceuticals and their safety and effectiveness. It is an important part of Total Quality Management (TQM), which aims to produce high-quality pharmaceuticals and implement quality management in the whole process from purchasing raw materials to completing production, packaging, storage, and sales, focusing on production and quality management while ensuring the production environment and conditions, and organizing and The GMP is to prevent the production of drugs in the production process and to ensure the production environment and conditions, to focus on production and quality management, and to monitor (including inspection) and record accurately all aspects of drug production. GMP is a necessary and effective means to prevent errors, confusion, and contamination in the production process and to ensure the quality of pharmaceutical products. The international community has long considered the implementation of GMP as a prerequisite for the quality assurance of pharmaceuticals, and compliance with GMP requirements and GMP certification determines the access of pharmaceuticals to the international pharmaceutical market.

During the 100 years of the 20th century, the development of quality management entered a growth period, which is generally divided into three stages. GMP was created in the 1960s, which was the beginning of total quality management.

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