First, GMP requirements The current GMP regulations implemented in China are GMP regulations developed by the WHO for developing countries. The emphasis is on the requirements for production hardware such as production equipment. The standards are relatively low, while the international GMPs implemented by the United States, Europe and Japan (ie, CurrentGoodManufacturePractice CGMP). Also known as dynamic pharmaceutical production management practices, its focus is on the production of software, such as the actions of operators and how to deal with emergencies in the production process. Comparing the current US GMP certification standards with the catalogues of China's GMP certification specifications, we can see that the differences and requirements of the two are different: A. General rules B. Organization and personnel Chapter II Organizations and personnel C. Plants and facilities Chapter III Plants and facilities D. Equipment Chapter 4 Equipment E. Control of ingredients, pharmaceutical containers and seals Chapter 5 Materials F. Production and processing control Chapter VI Hygiene G. Packaging and Label Control Chapter 7 Verification H. Storage and sales Chapter VIII documents I. Laboratory Control Chapter 9 Production Management J. Record and report Chapter 10 Quality Management K. Returned medicines and recycling treatment Chapter 11 Product sales and recovery Chapter Twelve Complaints and Adverse Reaction Report Chapter 13 Self-test Chapter 14 Supplementary Provisions As can be seen from the catalogue, in the three elements of the pharmaceutical production process - hardware systems, software systems and personnel, the US CGMP is simpler than the Chinese GMP, and there are few chapters. The difference in the internal requirements of these three elements is great. China's GMP has many hardware requirements, and the US CGMP has many requirements for software and personnel. This is because the quality of the production of the drug is fundamentally dependent on the operator's operation, so the role of personnel in CGMP management is more important than plant equipment. Internationally, GMP has become the basic norm for pharmaceutical production and quality management, and it is a systematic and scientific management system. The implementation of GMP not only proves the quality requirements through the inspection of the final product of zui, but also implements scientific comprehensive management and strict monitoring in the whole process of drug production to obtain the expected quality. The implementation of GMP can prevent contamination, mixed drugs and wrong drugs in the production process. GMP is a comprehensive quality management system for pharmaceutical production. In today's era, competition is becoming more and more fierce, and product quality is a magic weapon for all pharmaceutical companies to abide by and work hard. GMP provides the basic system for pharmaceutical companies that guarantee the quality of medicines. Second, GMP history GMP is an abbreviation for English name GoodManufacturingPracticesforDrugs or GoodPracticeintheManufacturing and QualityControlofDrugs. GMP can be literally translated as “excellent production practicesâ€; of course, we mainly refer to the production of pharmaceuticals. Food, cosmetics, etc. should also be produced in accordance with GMP, that is, "forFood" and "forCosmetic". Because "GMP" has been used habits like foreign words such as "TV". In addition to the documents, everyone has already agreed to become a common vocabulary in the world. China's GMP is called the "Good Manufacturing Practice". On June 18, 1999, the State Drug Administration promulgated the "Good Manufacturing Practices for Pharmaceutical Production (Revised in 1998)". GMP is an inevitable outcome of the development of human science and technology and the development of management science. It is produced to meet the needs of ensuring the quality management of pharmaceutical production. GMP originated from abroad and was born from a major drug catastrophe as a biocide. Looking back at the major inventions in medicine in the 20th century, representative drugs such as aspirin, sulfonamide, penicillin, insulin, and contraceptives are of epoch-making significance. They play a major role in human health care: but people also understand the adverse reactions of drugs. A great price has been paid. Sulfonamide (SN) is a modern chemotherapeutic compound. In 1935 the biologist Gerhardt. Domark has developed its antibacterial properties. Red Bailang multi-sex as a precursor of sulfonamide has also been used in clinical practice for more than 10 years. In 1937, a pharmacist in the United States of Tennessee formulated a sulfa guanidine agent, resulting in more than 300 people with acute renal failure and 107 deaths. The reason is that the sweetener diethylene glycol is oxidized into oxalic acid poisoning in the body: In the United States, the Federal Food, Cosmetics and Cosmetics Act (Federal Food, Drug, Cosmetic Act) was amended in 1938. This method was revised again in 1962. It was because of the 20th century Zui drug disaster in the world - the "reaction stop" event. In the late 1950s, the former Federal Republic of Germany, Glenn Nansu Pharmaceutical Factory produced a sedative called Thalidomide (also known as reaction stop, thalidomide, and peptide imidazolidone). Actually this is a 100% teratogenic drug. In the 6 years after the drug was sold, more than 12,000 cases of malformed fetuses were found in 28 countries in the former Federal Republic of Germany, Australia, Canada, Japan, and Latin America and Africa (including 6,000 to 8,000 cases in Western Europe and 1,000 cases in Japan). ). Children with congenital anomalies such as limbs, short limbs, paralysis between the limbs, and cardiac malformations are phocornelia. Thousands of people still live and cause a great burden on society. Another side effect of the reaction stop is that it can cause polyneuritis, which is about 1300 cases. The cause of this drug disaster is that the “reaction stop†has not undergone rigorous preclinical pharmacological experiments. Second, the Gelun Nansu pharmaceutical factory that has produced the drug has received more than 100 reports on the reaction to stop the toxicity. But they were all concealed by them. In 17 countries, the reaction has been re-concealed and concealed to continue to cause harm. For example, Japan did not stop the reaction until 1963, causing a great disaster; the movie "The Code" is a true portrayal of a victim. This teratogenic incident caused public outrage, and the parents of the children jointly filed a complaint with the court, called "the drug disaster of the 20th century." The original exaggerated propaganda of the manufacturers was attacked by public opinion, forcing government departments in some countries to strengthen the management of listed drugs. The drug factory had to be shut down because of the reaction stop. The United States, France, Czechoslovakia and other countries survived this disaster. The United States learned the lessons of the 1938 sulfa quinone agent incident and did not approve the import "response stop." At the time, the FDA (Food and Drug Administration) officials found that they lacked sufficient clinical trial data and refused to import. Thereby avoiding the disaster. Just because the private person took drugs from abroad, only 9 cases were deformed. However, the serious consequences of the incident caused anxiety in the United States, which aroused public interest in drug supervision and drug regulations, and led to major changes in Congress on the Food, Drug, and Cosmetic Act. The 1962 amendment clearly strengthened the role of the drug law, specifically in the following three aspects: (1) Require pharmaceutical companies not only to prove that the drug is effective, but also to prove that the drug is safe (2) Require pharmaceutical companies to report adverse reactions to drugs to the FDA. (3) Require pharmaceutical companies to implement pharmaceutical production and quality management practices. In accordance with the requirements of the amendment, the US Congress enacted the GMP of the Ministry of the World in 1963. GMPzui was originally prepared by six professors at Temple University in the United States. It was discussed and revised by FDA officials. In the United States, after several years of implementation of GMP. , did receive actual results. In 1967, the World Health Organization (WHO) published in the appendix of the International Pharmacopoeia (1967 edition) published: The 22nd World Health Assembly in 1969 recommended that the member states adopt the GMP system for pharmaceutical production. Ensure the quality of the drug and participate in the "International Trade Drug Quality Visa System" (CertificationSchemeOntheQualityOfPharmaceuticalProductsMovinginInternationalCommerce, referred to as the visa system). In 1973, the Japan Pharmaceutical Industry Association proposed its own GMP. In 1974, the Japanese government issued GMP to guide the implementation. In November 1975, WHO officially announced GMP. At the 28th World Health Assembly in 1977, WHO recommended GMP to member states again and determined it as WHO's regulations. GMP was revised and included in the Official Records of the World Health Organization. The GMP system proposed by WHO in Annex 12 is an important part of the overall quality management of pharmaceutical production. It is to ensure the quality of medicines and to reduce the possibility of accidents, mixed drugs and various types of pollution to a low level. The necessary conditions and a reliable approach to Zui, the United States reissued the revised GMP in 1978. In 1980, Japan decided to officially implement GMP. Since then, the United Kingdom, Japan and most European countries have begun to publicize, recognize and draft their own GMP, and the European Community Commission has promulgated the European Union's GMP. By 1980, 63 countries had promulgated GMP. Currently, more than 100 countries have implemented GMP systems. With the development of society and the advancement of science and technology, countries have continuously revised and improved them in the process of implementing GMP, and have formulated detailed rules and various guiding principles. For example, the British version of the GMP Guide has been published in 1985. , specific provisions for the implementation of GMP. Japan has also continually revised GMP, detailed regulations on various articles, and detailed regulations for pharmaceutical companies in accordance with GMP self-inspection requirements. In 1988, the Japanese government formulated the raw material GMP, which was officially implemented in 1990. After the WHO revised the GMP in 1990, it was revised again in 1992. It includes the following four aspects: (1) Introduction, general theory and terminology introduce the generation, function and terminology used in GMP (2) Quality management objectives and basic elements in the pharmaceutical industry. This part includes 14 aspects including QA, GMP, QC, environment and sanitation, verification, user complaints, product recovery, contract production and contract analysis, self-inspection and quality review, personnel, plant, equipment, materials and documents. (3) Production and quality control This part includes production and quality control. (4) Guidelines for supplementation include GMP for sterilized drugs and active drug components (APIs) Third, GMP classification (1) From the scope of GMP application, the current GMP can be divided into three categories: 1 GMP with international properties. For example, WHO's GMP, pic-GMP developed by the seven Nordic Free Trade Associations (pic is the PharmaceuticalInspection Convention), the GMP of the Association of Southeast Asian Nations, etc. 2 GMP issued by the National Authority. Such as the Ministry of Health of the People's Republic of China and later the State Drug Administration, the US FDA, the British Ministry of Health and Social Insurance, the Japanese Ministry of Health and Welfare and other government agencies to develop GMP. 3 GMP developed by industrial organizations. As formulated by the United States Pharmaceutical Industry Association, the standard is not lower than the GMP established by the US government, the GMP implementation guidelines formulated by the Chinese pharmaceutical industry, and even the pharmaceutical companies or companies themselves. (2) From the nature of the GMP system, it can be divided into two categories: 1 GMP is required as a code. Such as the United States, Japan, China's GMP. 2 GMP is recommended as a guideline. Some GMPs play a guiding role in pharmaceutical production and quality management, such as the GMP of the UN WHO. In general, it is a general trend for countries to conduct drug production management and quality management in accordance with GMP requirements; the GMP content of each country is basically the same, but it also has its own characteristics. For special varieties, such as large infusions, large infusion GMP (LVP-GMP, LargeVolume Parenteral-GMP) can also be formulated separately. Practice has proved that GMP is an effective scientific and systematic management system, which plays a positive role in ensuring the quality of medicines and has been widely recognized internationally. The WHO's "International Trade Drug Quality Visa System" has stipulated that export pharmaceutical factories must produce in accordance with GMP regulations, and accept the supervision of the drug regulatory authorities of the importing country in accordance with GMP regulations. Thus, the production of drugs in accordance with GMP requirements has become a drug entry. As a prerequisite for the international market, GMP has become the basis for international drug quality control and inspection. In recent years, in order to enhance export competitiveness, some pharmaceutical companies in China have started the preparation of drug master files (DMF, DrugMasterFile, or drug management files) based on the implementation of GMP. DMF is a document required to apply to the EU EU and the US FDA for entry into the European and American markets. The DMF serves as a “passportâ€. China has also strictly followed the procedures for registration and acceptance of drugs manufactured by foreign countries and joint ventures to China.
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