5 thoughts on “What does drug GMP certification and GSP, GAP, GCP, GLP certification mean?”
Vanessa
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. The expansion information: The quality assurance system should ensure: (1) the design and research and development of drugs reflect the requirements of this specification; (2) production management and quality control activities meet the current The requirements of the specifications; (3) clear management responsibilities; (4) The raw and auxiliary materials and packaging materials used to procurement and use; (5) The middle product is effectively controlled; (6) the implementation of confirmation and verification; (7) Strictly carried out production, inspection, inspection and review in strict accordance with the regulations; (8) Each product is approved by the quality of the products to be released; r; r; (9) Proper measures to ensure the quality of drugs in the storage, shipping, transportation and subsequent operations; (10) In accordance with the self -inspection operation regulations Essence Reference materials Source: Baidu Encyclopedia-Drug Production Quality Management Specifications
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. 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. 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. The expansion data GMP is a set of mandatory standards suitable for pharmaceutical, food and other industries. It is required that enterprises are required to meet the quality requirements of sanitary quality in accordance with relevant national regulations in accordance with relevant national regulations, such as raw materials, personnel, facilities and equipment, production processes, packaging and transportation, and quality control. Formed 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 pharmaceutical, food and other manufacturers should have good production equipment, reasonable production processes, perfect quality management and strict detection systems to ensure the quality of the final product (including food safety (including food safety Health) meets regulatory requirements. Reference materials: Baidu Encyclopedia_Charmaceutical Business Quality Management Specifications
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: It is an English abbreviation for the quality management of drug production. GSP: It is an English abbreviation for the standardized quality management of drugs. GLP: It is an English abbreviation for the standardized quality management of drugs. GCP: It is an English abbreviation for the standardized quality management of drug clinical trials. GPP: It is an English abbreviation for medical institutions to prepare quality management specifications. Gap: It is an English abbreviation of standardized quality management of Chinese medicinal materials. gup: It is an English abbreviation for drugs using quality management specifications. "GMP" is the abbreviation of English Good Practice. In particular, we pay special attention to the implementation of the autonomous management system for product quality and hygiene and safety. It is a set of compulsory standards for pharmaceuticals, food and other industries. It requires enterprises to meet the requirements of sanitary quality in accordance with relevant national regulations in accordance with the requirements of national regulations in accordance with the requirements of raw materials, personnel, facilities, facilities and equipment, production processes, packaging and transportation, and quality control. The operation standards help enterprises to improve the sanitary environment of the enterprise, timely discover problems in the production process, and improve it. GSP is the abbreviation of English Good Supplying Practice, which is literally translated as a good pharmaceutical supply specification. 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. glp is an abbreviation of English Good Practice, and Chinese literal translation is a fine laboratory specification. GLP is a series of regulatory documents formulated from a series of management from the laboratory experimental research from a series of management from planning, experiment, supervision, records to experimental reports, and all aspects of laboratory work. It is mainly based on the safety evaluation experiments made by medicine, pesticides, food additives, cosmetics, veterinary drugs, etc. The main purpose of formulating GLP is to strictly control the various aspects of chemical safety evaluation tests, 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. Peropic clinical practice (GCP), which is developed to ensure the scientific, reliability and reproducible specifications of drug clinical trials. GCP protects the safety and interests of volunteer subjects and patients in the heart to study, and at the same time stipulates valuable clinical data that producers apply for clinical experiments. gap is the abbreviation of Good Practices, and Chinese consciousness is "good agricultural specifications".
These are the specifications for ensuring drug safety production. The specific "GOOD Practice (GMP) is the basic criterion for drug production and quality management. It is suitable for the entire process and raw materials for drug preparation production The key process of affecting the quality of the finished product in medicine. GMP certification refers to the organized by the Provincial Food and Drug Administration to organize GMP review experts to all enterprises, training, factory facilities, production environment, sanitary conditions, material management, production management, quality management, sales management and other enterprises involved in all companies involved in enterprises involved in enterprises involved Check the link to evaluate whether the process of regulating requirements.
"Specifications for Drug Business Quality Management" Good Supplying Practice GSP. 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. is a unified quality management standard for drug management enterprises. Pharmaceutical business enterprises shall meet the GSP requirements within the time stipulated by the drug supervision and management department and obtain a certification certificate through certification.
The quality management specifications of traditional Chinese medicinal materials (trial) ", GOOD PRACTICES, referred to as GAP, which covers the entire process of production of Chinese medicinal materials and is the basic criterion for the production and quality management of Chinese medicinal materials. It is suitable for the entire process of producing Chinese medicinal materials (including botanical medicines and animal medicines) for Chinese medicinal materials manufacturers. glp (Good Practice of Drug) Drugs for non -clinical research quality management specifications. It refers to the organizational management, working methods and relevant conditions of the laboratory of the planning, designing, implementing, management supervision and recording reports engaged in experimental research.
"Pharmaceutical Clinical Test Management Specifications", Good Clinical Practice GCP is the standard for regulating the entire process of drug clinical trials. The purpose is to ensure the specifications of the clinical trial process. Rights and guarantees their security.
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.
The expansion information:
The quality assurance system should ensure:
(1) the design and research and development of drugs reflect the requirements of this specification;
(2) production management and quality control activities meet the current The requirements of the specifications;
(3) clear management responsibilities;
(4) The raw and auxiliary materials and packaging materials used to procurement and use;
(5) The middle product is effectively controlled;
(6) the implementation of confirmation and verification;
(7) Strictly carried out production, inspection, inspection and review in strict accordance with the regulations;
(8) Each product is approved by the quality of the products to be released; r; r;
(9) Proper measures to ensure the quality of drugs in the storage, shipping, transportation and subsequent operations;
(10) In accordance with the self -inspection operation regulations Essence
Reference materials Source: Baidu Encyclopedia-Drug Production Quality Management Specifications
Reference materials Source: Baidu Encyclopedia-Chinese Medicinal Materials Production Quality Management Specifications
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.
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.
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.
The expansion data GMP is a set of mandatory standards suitable for pharmaceutical, food and other industries. It is required that enterprises are required to meet the quality requirements of sanitary quality in accordance with relevant national regulations in accordance with relevant national regulations, such as raw materials, personnel, facilities and equipment, production processes, packaging and transportation, and quality control. Formed 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 pharmaceutical, food and other manufacturers should have good production equipment, reasonable production processes, perfect quality management and strict detection systems to ensure the quality of the final product (including food safety (including food safety Health) meets regulatory requirements.
Reference materials: Baidu Encyclopedia_Charmaceutical Business Quality Management Specifications
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: It is an English abbreviation for the quality management of drug production.
GSP: It is an English abbreviation for the standardized quality management of drugs.
GLP: It is an English abbreviation for the standardized quality management of drugs.
GCP: It is an English abbreviation for the standardized quality management of drug clinical trials.
GPP: It is an English abbreviation for medical institutions to prepare quality management specifications.
Gap: It is an English abbreviation of standardized quality management of Chinese medicinal materials.
gup: It is an English abbreviation for drugs using quality management specifications.
"GMP" is the abbreviation of English Good Practice. In particular, we pay special attention to the implementation of the autonomous management system for product quality and hygiene and safety. It is a set of compulsory standards for pharmaceuticals, food and other industries. It requires enterprises to meet the requirements of sanitary quality in accordance with relevant national regulations in accordance with the requirements of national regulations in accordance with the requirements of raw materials, personnel, facilities, facilities and equipment, production processes, packaging and transportation, and quality control. The operation standards help enterprises to improve the sanitary environment of the enterprise, timely discover problems in the production process, and improve it.
GSP is the abbreviation of English Good Supplying Practice, which is literally translated as a good pharmaceutical supply specification. 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.
glp is an abbreviation of English Good Practice, and Chinese literal translation is a fine laboratory specification. GLP is a series of regulatory documents formulated from a series of management from the laboratory experimental research from a series of management from planning, experiment, supervision, records to experimental reports, and all aspects of laboratory work. It is mainly based on the safety evaluation experiments made by medicine, pesticides, food additives, cosmetics, veterinary drugs, etc. The main purpose of formulating GLP is to strictly control the various aspects of chemical safety evaluation tests, 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.
Peropic clinical practice (GCP), which is developed to ensure the scientific, reliability and reproducible specifications of drug clinical trials. GCP protects the safety and interests of volunteer subjects and patients in the heart to study, and at the same time stipulates valuable clinical data that producers apply for clinical experiments.
gap is the abbreviation of Good Practices, and Chinese consciousness is "good agricultural specifications".
These are the specifications for ensuring drug safety production. The specific
"GOOD Practice (GMP) is the basic criterion for drug production and quality management. It is suitable for the entire process and raw materials for drug preparation production The key process of affecting the quality of the finished product in medicine.
GMP certification refers to the organized by the Provincial Food and Drug Administration to organize GMP review experts to all enterprises, training, factory facilities, production environment, sanitary conditions, material management, production management, quality management, sales management and other enterprises involved in all companies involved in enterprises involved in enterprises involved Check the link to evaluate whether the process of regulating requirements.
"Specifications for Drug Business Quality Management" Good Supplying Practice GSP. 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.
is a unified quality management standard for drug management enterprises. Pharmaceutical business enterprises shall meet the GSP requirements within the time stipulated by the drug supervision and management department and obtain a certification certificate through certification.
The quality management specifications of traditional Chinese medicinal materials (trial) ", GOOD PRACTICES, referred to as GAP, which covers the entire process of production of Chinese medicinal materials and is the basic criterion for the production and quality management of Chinese medicinal materials. It is suitable for the entire process of producing Chinese medicinal materials (including botanical medicines and animal medicines) for Chinese medicinal materials manufacturers.
glp (Good Practice of Drug) Drugs for non -clinical research quality management specifications. It refers to the organizational management, working methods and relevant conditions of the laboratory of the planning, designing, implementing, management supervision and recording reports engaged in experimental research.
"Pharmaceutical Clinical Test Management Specifications", Good Clinical Practice GCP is the standard for regulating the entire process of drug clinical trials. The purpose is to ensure the specifications of the clinical trial process. Rights and guarantees their security.