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Current Good Manufacturing Practices
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food Industry
The food industry is a complex, global network of diverse businesses that supplies most of the food consumed by the world's population. The food industry today has become highly diversified, with manufacturing ranging from small, traditional, family-run activities that are highly labor-intensive, to large, capital-intensive and highly mechanized industrial processes. Many food industries depend almost entirely on local agriculture, produce, or fishing. It is challenging to find an inclusive way to cover all aspects of food production and sale. The UK Food Standards Agency describes it as "the whole food industry – from farming and food production, packaging and distribution, to retail and catering." The Economic Research Service of the USDA uses the term ''food system'' to describe the same thing, stating: "The U.S. food system is a complex network of farmers and the industries that link to them. Those links include makers of farm equipment and chemicals as well as firms ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
World Health Organization
The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of health". Headquartered in Geneva, Switzerland, it has six regional offices and 150 field offices worldwide. The WHO was established on 7 April 1948. The first meeting of the World Health Assembly (WHA), the agency's governing body, took place on 24 July of that year. The WHO incorporated the assets, personnel, and duties of the League of Nations' Health Organization and the , including the International Classification of Diseases (ICD). Its work began in earnest in 1951 after a significant infusion of financial and technical resources. The WHO's mandate seeks and includes: working worldwide to promote health, keeping the world safe, and serve the vulnerable. It advocates that a billion more people should have: universal health care coverag ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Clinical Practice
Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research. High standards are required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities, including computers and software. Quality assurance and inspections ensure that these standards are achieved. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented. GCP guidelines include protection of human rights for the subjects and volunteers in a clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. GCP guidelines include standards on how cl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Agricultural Practice
Good agricultural practice (GAP) is a certification system for agriculture, specifying procedures (and attendant documentation) that must be implemented to create food for consumers or further processing that is safe and wholesome, using sustainable methods. While there are numerous competing definitions of what methods constitute good agricultural practice, there are several broadly accepted schemes that producers can adhere too. Motivation Introduction of GAP is particularly desirable when there is chronic overuse and misuse of agricultural pesticides. Governments seek to reduce the use of pesticides by promoting alternative methods of pest management, while at the same time ensuring a steady production of safe and wholesome food. Organizations Food and Agricultural Organization (FAO) of the United Nations GAP The Food and Agricultural Organization of the United Nations (FAO) uses good agricultural practice as a collection of principles applying to on-farm production and po ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Federal Food, Drug, And Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations. The introduction of this act was influenced by the death of more than 100 patients due to elixir sulfanilamide, a sulfanilamide medication where the toxic solvent diethylene glycol was us ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Inspectorate
An inspectorate or inspectorate-general (or general inspectorate) is a civil or military body charged with inspecting and reporting on some institution or institutions in its field of competence. Inspectorates cover a broad spectrum of organizations which vary in a number of terms, notably whether and to the degree to which they become involved in criminal investigations; the extent to which they achieve independence from the institutions being inspected; as well as the nature of their inspection regimes and reporting processes. Inspectorates are commonplace in government; for example, in the United States, there are some 73 standard form Office of the Inspector Generals charged with examining the actions of a government agency, military organization, or military contractor as a general auditor of their operations and headed by an inspector general. Inspectorates in various jurisdictions oversee civil activities such as mining and the nuclear industry. Many regulatory agencies incor ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
NAFDAC
The National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria is a federal agency under the Federal Ministry of Health that is responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, chemicals and packaged water. The agent is headed by DrMonica Eimunjezein acting capacity on November 12, 2022, according to an internal memo dated November 17, 2022, signed by Oboli A.U and copied to all Directors at the agency, follows the expiration of Prof Mojisola Adeyeye. She was appointed on 12 November 2022 by the President of Federal Republic of Nigeria as the acting Director-General of National Agency for Food and Drug Administration and Control (NAFDAC). Formation The organization was established to counter illicit and counterfeit products in Nigeria in 1993 under the country's health and safety law. Adulterated and counterfeit drugs are a problem ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Central Drugs Standard Control Organization
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for cosmetics , pharmaceuticals and medical devices. It serves a similar function to the European Medicines Agency of the European Union, the PMDA of Japan, the Food and Drug Administration (FDA) of the United States, and the Medicines and Healthcare products Regulatory Agency of the United Kingdom, and the National Medical Products Administration (NMPA) of China. The Indian government has announced its plan to bring all medical devices, including implants and contraceptives under a review of the Central Drugs and Standard Control Organisation (CDSCO). Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices and is positioning within the Ministry of Health and Family Welfare. The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC). Divided into zonal offices, each one carries out pre-lice ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
National Health Surveillance Agency
Brazilian Health Regulatory Agency ( pt, Agência Nacional de Vigilância Sanitária, links=no, italics=yes, ''Anvisa'', literally National Health Surveillance Agency) is a regulatory body of the Brazilian government, created in 1999 during President Fernando Henrique Cardoso's term of office. It is responsible for the regulation and approval of pharmaceutical drugs, sanitary standards and regulation of the food industry. The agency bills itself as "an independently administered, financially autonomous" regulatory body. It is administered by a five-member collegiate board of directors, who oversee five thematic directorates, assisted by a five-tier oversight structure. Since September 2018 the agency is headed by Antonio Barra Torres. Pesticide approvals and monitoring Brazil is the world's largest consumer of pesticides. They are primarily used in the production of soy and corn. The number of approved pesticides increased "rapidly" between 2015 and 2019. Tereza Cristina, the ag ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Therapeutic Goods Administration
The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. As part of the Department of Health and Aged Care, the TGA regulates the quality, supply and advertising of medicines, pathology devices, medical devices, blood products and most other therapeutics. Any items that claim to have a therapeutic effect, are involved in the administration of medication, or are otherwise covered by the ''Therapeutic Goods Act 1989'', the ''Therapeutic Goods Regulations 1990'', or a ministerial order, must be approved by the TGA and registered in the Australian Register of Therapeutic Goods. Structure of the TGA and medical regulation in Australia In Australia, medical products are regulated by the TGA and, for controlled drugs such as cannabis, the Office of Drug Control (ODC). Together, the TGA and ODC form the Health Products Regulation Group within the Department of Health and Aged Care. The Health Products Regulation Group ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Ministry Of Food And Drug Safety
Ministry may refer to: Government * Ministry (collective executive), the complete body of government ministers under the leadership of a prime minister * Ministry (government department), a department of a government Religion * Christian ministry, activity by Christians to spread or express their faith ** Minister (Christianity), clergy authorized by a church or religious organization to perform teaching or rituals ** Ordination, the process by which individuals become clergy * Ministry of Jesus, activities described in the Christian gospels * ''Ministry'' (magazine), a magazine for pastors published by the Seventh-day Adventist Church Music * Ministry (band), an American industrial metal band * Ministry of Sound, a London nightclub and record label Fiction * Ministry (comics), a horror comic book created by writer-artist Lara J. Phillips * Ministry of Magic, governing body in the ''Harry Potter'' series * Ministry of Darkness, a professional wrestling stable led by Th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medicines And Healthcare Products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe. The MHRA was formed in 2003 with the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). In April 2013, it merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with the MHRA identity being used solely for the regulatory centre within the group. The agency employs more than 1,200 people in London, York and South Mimms, Hertfordshire. Structure The MHRA is divided into three main centres: * MHRA Regulatory – the regulator for the pharmaceutical and medical devices industries * Clinical Practice Research Datalink – licences anonymised health care data to pharmaceutical companies, academics and other regulators for research * National Institute for Biolog ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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