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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 manageme ... [...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 labour-intensive, to large, capital-intensive and highly mechanized industrial processes. Many food industries depend almost entirely on local agriculture, animal farms, produce, and/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 chemica ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
International Organization For Standardization
The International Organization for Standardization (ISO ; ; ) is an independent, non-governmental, international standard development organization composed of representatives from the national standards organizations of member countries. Membership requirements are given in Article 3 of the ISO Statutes. ISO was founded on 23 February 1947, and () it has published over 25,000 international standards covering almost all aspects of technology and manufacturing. It has over 800 technical committees (TCs) and subcommittees (SCs) to take care of standards development. The organization develops and publishes international standards in technical and nontechnical fields, including everything from manufactured products and technology to food safety, transport, IT, agriculture, and healthcare. More specialized topics like electrical and electronic engineering are instead handled by the International Electrotechnical Commission.Editors of Encyclopedia Britannica. 3 June 2021.Inte ... [...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 food safety, safety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was Charles W. Crawford (chemist), Charles W. Crawford. 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 influe ... [...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 Inspector General (United States), Offices of the Inspector General 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 nucl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
NAFDAC
The National Agency for Food and Drug Administration and Control (NAFDAC) is a Nigerian 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 agency is headed by Mojisola Adeyeye, who was appointed in 2017 by the President of the Federal Republic of Nigeria as the director-general. She completed her five-year term on 2 November 2022 and was reappointed for a second term on 1 December 2022. Formation The organisation 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 in Nigeria. In one 1989 incident, over 150 children died as a result of paracetamol syrup containing diethylene glycol. The problem of fake drugs was so severe that neighbouring co ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Drug Regulatory Authority Of Pakistan
The Drug Regulatory Authority of Pakistan (DRAP) is a self-governing entity under the Federal Government of Pakistan. It functions under the administrative supervision of the Ministry of National Health Services, Regulations & Coordination. DRAP was formed in accordance with the ''DRAP Act 2012'' and is tasked with ensuring effective coordination and implementation of ''The Drugs Act, 1976''. Role and responsibilities DRAP is committed to ensuring that all drugs, medical devices, cosmetics, alternative medicines, and health products meet a certain standard of quality and are safe and effective for use. It is responsible for making sure that therapeutic goods, which are approved and available in the market, comply with the prescribed standards of quality, safety, and efficacy. The regulatory tasks carried out by DRAP encompass registration and marketing authorization, vigilance, market surveillance and control, licensing establishments, regulatory inspection, laboratory testing, cl ... [...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 Food and Drug Administration (FDA) of the United States or the European Medicines Agency of the European Union. 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-licensing and post-licensing inspections, post-market surveillance, and drug recalls (where necessary). Manufacturers who deal with the authority required to name an Autho ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
National Health Surveillance Agency
The Brazilian Health Regulatory Agency (, ''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. __TOC__ 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 agriculture minister, noted that "there is no general liberat ... [...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, Disability and Ageing, the TGA regulates the safety, quality, efficacy and advertising in Australia of therapeutic goods (which comprise medicines, medical devices, biologicals and certain other therapeutic goods). Therapeutic goods include goods that are represented to have a therapeutic effect, are included in a class of goods the sole or principal use of which is (or ordinarily is) a therapeutic use, or are otherwise determined to be a therapeutic good through a legislative instrument under the ''Therapeutic Goods Act 1989.'' Goods that are therapeutic goods must be entered on the Australian Register of Therapeutic Goods (ARTG), or otherwise be the subject of an exemption, approval or authority by the TGA under the ''Therapeutic Goods Act 1989'', ''Therapeutic Goods Regulations 1990'' or ''Therapeutic Goods (Medical Dev ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Ministry Of Food And Drug Safety
The Ministry of Food and Drug Safety (MFDS; ), formerly known as the Korea Food & Drug Administration (KFDA; ), is a government agency responsible for promoting public health by ensuring the safety and effectiveness of foods, pharmaceuticals, medical devices, and cosmetics as well as supporting the food and pharmaceutical industry in South Korea South Korea, officially the Republic of Korea (ROK), is a country in East Asia. It constitutes the southern half of the Korea, Korean Peninsula and borders North Korea along the Korean Demilitarized Zone, with the Yellow Sea to the west and t .... The main goal is to offer people safe foods and drugs. The headquarters are located in the Osong Health Technology Administration Complex in Cheongju, North Chungcheong Province. MFDS is a regulatory member of the International Council for Harmonisation (ICH). History In April 1996, Korea Food and Drug Safety and its six regional offices were established. In 1998, it was raised to the ... [...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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical guidelines and requirements for pharmaceutical product registration. Harmonisation leads to a more rational use of human, animal and other resources, the elimination of unnecessary delay in the global development, and availability of new medicines while maintaining safeguards on quality, safety, efficacy, and regulatory obligations to protect public health. Junod notes in her 2005 treatise on clinical drug trials that " ove all, the ICH has succeeded in aligning clinical trial requirements." History In the 1980s, the European Union began harmonising regulatory requir ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
