3 thoughts on “What does drug GMP certification and GSP, GAP, GCP, GLP authentication mean”
Blanca
1. GMP certification: standardized quality management of drug production. It is the basic criterion for drug production and quality management. It is suitable for the entire process of drug preparation production and the key process that affects the quality of finished products in the production of raw drugs. Vigorously promoting the drug GMP is to maximize the pollution and cross -pollution in the production process of drugs, and reduce the occurrence of various errors. It is an important measure to improve the quality of drugs. 2, GSP certification: standardized quality management of drugs. It refers to a management system that guarantees the quality standards complied with quality standards in the process of planning, purchase acceptance, storage, sales, and after -sales service in the process of pharmaceutical circulation. Its core is to restrict the behavior of enterprises through strict management systems, and perform quality control of the entire process of drug management to ensure high -quality medicines to users. 3, GAP certification: standardized quality management of traditional Chinese medicinal materials. It is determined to ensure the quality of Chinese medicinal materials. From ecological environment, planting to cultivation, transportation, and packaging, each link must be under strict control. 4, GCP certification: quality management specifications for clinical trials of drugs. It is the standard for regulating the entire process of drug clinical trials. The purpose is to ensure the specifications of the clinical trial process. As a result, scientific and reliable, protecting the subjects of the subjects and protecting their safety. 5, GLP certification: quality management specifications for non -clinical research of drugs. The main purpose of formulating GLP is to strictly control the various links of the safety evaluation test of chemical drugs, that is, strictly controlling various subjective and objective factors that may affect the accuracy of the experimental results, reduce the test error, and ensure the authenticity of the experimental results. Extension information: GMP is a set of mandatory standards suitable for pharmaceuticals, food and other industries. It is required that enterprises are required to be raw materials, personnel, facilities, production processes, packaging and transportation, quality control, etc. To meet the requirements of sanitary quality, form a set of operating operating specifications to help enterprises improve the health environment of the enterprise, and timely discover problems in the production process, and improve it. It, GMP requires that pharmaceuticals, food and other manufacturers should have good production equipment, reasonable production processes, perfect quality management and strict testing systems to ensure that the quality of the final product (including food safety and health) meets regulations in compliance with regulations Require. The World Health Organization, in the 1960s, began to organize the formulation of Drug GMP, and China was implemented since the 1980s. China ’s drug GMP was promulgated in 1988, and the first revision was made in 1992. For more than a decade, China has achieved certain results in GMP. A group of pharmaceutical companies (workshops) have successively passed the drug GMP certification and standards, which has promoted the improvement of the production and quality of the pharmaceutical industry. Since the establishment of the State Drug Administration on August 19, 1998, it attaches great importance to the revision of the drug GMP. The opinions of the enterprise organize relevant experts to carry out revision. "Specifications for the Management of Drug Production Quality" (revised in 1998) was released by the Director Ling of the State Drug Administration No. 9 and implemented it on August 1, 1999. After 5 years of revision and two public opinions, the "Drug Production Quality Management Specification 2010 Amendment" was implemented on March 1, 2011. Reference materials Source: Baidu Encyclopedia_Pharmaceutical Production Quality Management Specifications Reference materials Source: Baidu Encyclopedia_Pharmaceutical Business Quality Management Specifications
GMP is the quality management specification of pharmaceutical production ---- is a production standard that meets this standard. The Pharmaceutical Bureau will issue a GMP certificate. This is a must-have certificate for manufacturers. GSP is a drug management quality management specification --- is a type of management management standard. You will issue a certificate if you meet the standard. If you have this certificate, you can buy and sell medicines. gap is the quality management specification of the production of Chinese medicinal materials. gcp is the quality management specification of drug clinical trials. glp is a quality management specification for drug non -clinical research. The expansion information "Good Practice of Medical Procts (GMP) is the basic criterion for drug production and quality management. It is suitable for the entire process of pharmaceutical preparations and the key to the quality of the product that affects the quality of the finished product. Work. Vigorously promoting the drug GMP is to maximize the pollution and cross -pollution in the production process of drugs, and reduce the occurrence of various errors. It is an important measure to improve the quality of drugs.
Reference quality management specifications of data drug production_ 百度 文
GMP is the quality management specification of pharmaceutical production ---- is a production standard that meets this standard. The Pharmaceutical Bureau will issue a GMP certificate. This is a must-have certificate for manufacturers.
GSP is a drug management quality management specification --- is a type of business management standard. You will issue a certificate if you meet the standard. If you have this certificate, you can buy and sell medicines.
GAP is the quality management specification of the production of Chinese medicinal materials
gcp is the drug clinical trial quality management specification
glp is the quality management specification of the drug non -clinical research quality management
1. GMP certification: standardized quality management of drug production. It is the basic criterion for drug production and quality management. It is suitable for the entire process of drug preparation production and the key process that affects the quality of finished products in the production of raw drugs. Vigorously promoting the drug GMP is to maximize the pollution and cross -pollution in the production process of drugs, and reduce the occurrence of various errors. It is an important measure to improve the quality of drugs.
2, GSP certification: standardized quality management of drugs. It refers to a management system that guarantees the quality standards complied with quality standards in the process of planning, purchase acceptance, storage, sales, and after -sales service in the process of pharmaceutical circulation. Its core is to restrict the behavior of enterprises through strict management systems, and perform quality control of the entire process of drug management to ensure high -quality medicines to users.
3, GAP certification: standardized quality management of traditional Chinese medicinal materials. It is determined to ensure the quality of Chinese medicinal materials. From ecological environment, planting to cultivation, transportation, and packaging, each link must be under strict control.
4, GCP certification: quality management specifications for clinical trials of drugs. It is the standard for regulating the entire process of drug clinical trials. The purpose is to ensure the specifications of the clinical trial process. As a result, scientific and reliable, protecting the subjects of the subjects and protecting their safety.
5, GLP certification: quality management specifications for non -clinical research of drugs. The main purpose of formulating GLP is to strictly control the various links of the safety evaluation test of chemical drugs, that is, strictly controlling various subjective and objective factors that may affect the accuracy of the experimental results, reduce the test error, and ensure the authenticity of the experimental results.
Extension information:
GMP is a set of mandatory standards suitable for pharmaceuticals, food and other industries. It is required that enterprises are required to be raw materials, personnel, facilities, production processes, packaging and transportation, quality control, etc. To meet the requirements of sanitary quality, form a set of operating operating specifications to help enterprises improve the health environment of the enterprise, and timely discover problems in the production process, and improve it.
It, GMP requires that pharmaceuticals, food and other manufacturers should have good production equipment, reasonable production processes, perfect quality management and strict testing systems to ensure that the quality of the final product (including food safety and health) meets regulations in compliance with regulations Require.
The World Health Organization, in the 1960s, began to organize the formulation of Drug GMP, and China was implemented since the 1980s. China ’s drug GMP was promulgated in 1988, and the first revision was made in 1992. For more than a decade, China has achieved certain results in GMP. A group of pharmaceutical companies (workshops) have successively passed the drug GMP certification and standards, which has promoted the improvement of the production and quality of the pharmaceutical industry.
Since the establishment of the State Drug Administration on August 19, 1998, it attaches great importance to the revision of the drug GMP. The opinions of the enterprise organize relevant experts to carry out revision.
"Specifications for the Management of Drug Production Quality" (revised in 1998) was released by the Director Ling of the State Drug Administration No. 9 and implemented it on August 1, 1999. After 5 years of revision and two public opinions, the "Drug Production Quality Management Specification 2010 Amendment" was implemented on March 1, 2011.
Reference materials Source: Baidu Encyclopedia_Pharmaceutical Production Quality Management Specifications
Reference materials Source: Baidu Encyclopedia_Pharmaceutical Business Quality Management Specifications
GMP is the quality management specification of pharmaceutical production ---- is a production standard that meets this standard. The Pharmaceutical Bureau will issue a GMP certificate. This is a must-have certificate for manufacturers.
GSP is a drug management quality management specification --- is a type of management management standard. You will issue a certificate if you meet the standard. If you have this certificate, you can buy and sell medicines.
gap is the quality management specification of the production of Chinese medicinal materials.
gcp is the quality management specification of drug clinical trials.
glp is a quality management specification for drug non -clinical research.
The expansion information "Good Practice of Medical Procts (GMP) is the basic criterion for drug production and quality management. It is suitable for the entire process of pharmaceutical preparations and the key to the quality of the product that affects the quality of the finished product. Work. Vigorously promoting the drug GMP is to maximize the pollution and cross -pollution in the production process of drugs, and reduce the occurrence of various errors. It is an important measure to improve the quality of drugs.
Reference quality management specifications of data drug production_ 百度 文
GMP is the quality management specification of pharmaceutical production ---- is a production standard that meets this standard. The Pharmaceutical Bureau will issue a GMP certificate. This is a must-have certificate for manufacturers.
GSP is a drug management quality management specification --- is a type of business management standard. You will issue a certificate if you meet the standard. If you have this certificate, you can buy and sell medicines.
GAP is the quality management specification of the production of Chinese medicinal materials
gcp is the drug clinical trial quality management specification
glp is the quality management specification of the drug non -clinical research quality management