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Good Engineering Practice
"Good engineering practice" or "GEP" is engineering and technical activities that ensure that a company manufactures products of the required quality as expected (e.g., by the relevant regulatory authorities). Good engineering practices are to ensure that the development and/or manufacturing effort consistently generates deliverables that support the requirements for qualification or validation. Good engineering practices are applied to all industries that require engineering. See also * GxP * Good manufacturing practice (GMP) * Best practice * American National Standards Institute (ANSI) * Institute of Electrical and Electronics Engineers (IEEE) * European Medicines Agency (EMEA) * Food and Drug Administration (FDA) * Ministry of Health, Labour and Welfare (Japan) * Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) Sources Risk-Based Qualification for the 21st CenturyISPE GAMP COP Good In most contexts, the concept of good denotes ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Engineering
Engineering is the use of scientific method, scientific principles to design and build machines, structures, and other items, including bridges, tunnels, roads, vehicles, and buildings. The discipline of engineering encompasses a broad range of more specialized List of engineering branches, fields of engineering, each with a more specific emphasis on particular areas of applied mathematics, applied science, and types of application. See glossary of engineering. The term ''engineering'' is derived from the Latin ''ingenium'', meaning "cleverness" and ''ingeniare'', meaning "to contrive, devise". Definition The American Engineers' Council for Professional Development (ECPD, the predecessor of Accreditation Board for Engineering and Technology, ABET) has defined "engineering" as: The creative application of scientific principles to design or develop structures, machines, apparatus, or manufacturing processes, or works utilizing them singly or in combination; or to construct o ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Manufacturing Practice
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 managemen ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Best Practice
A best practice is a method or technique that has been generally accepted as superior to other known alternatives because it often produces results that are superior to those achieved by other means or because it has become a standard way of doing things, e.g., a standard way of complying with legal or ethical requirements. Best practices are used to maintain quality as an alternative to mandatory legislated standards and can be based on self-assessment or benchmarking. Best practice is a feature of accredited management standards such as ISO 9000 and ISO 14001. Some consulting firms specialize in the area of best practice and offer ready-made templates to standardize business process documentation. Sometimes a best practice is not applicable or is inappropriate for a particular organization's needs. A key strategic talent required when applying best practice to organizations is the ability to balance the unique qualities of an organization with the practices that it has in common ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
American National Standards Institute
The American National Standards Institute (ANSI ) is a private non-profit organization that oversees the development of voluntary consensus standards for products, services, processes, systems, and personnel in the United States. The organization also coordinates U.S. standards with international standards so that American products can be used worldwide. ANSI accredits standards that are developed by representatives of other standards organizations, government agencies, consumer groups, companies, and others. These standards ensure that the characteristics and performance of products are consistent, that people use the same definitions and terms, and that products are tested the same way. ANSI also accredits organizations that carry out product or personnel certification in accordance with requirements defined in international standards. The organization's headquarters are in Washington, D.C. ANSI's operations office is located in New York City. The ANSI annual operating b ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Institute Of Electrical And Electronics Engineers
The Institute of Electrical and Electronics Engineers (IEEE) is a 501(c)(3) professional association for electronic engineering and electrical engineering (and associated disciplines) with its corporate office in New York City and its operations center in Piscataway, New Jersey. The mission of the IEEE is ''advancing technology for the benefit of humanity''. The IEEE was formed from the amalgamation of the American Institute of Electrical Engineers and the Institute of Radio Engineers in 1963. Due to its expansion of scope into so many related fields, it is simply referred to by the letters I-E-E-E (pronounced I-triple-E), except on legal business documents. , it is the world's largest association of technical professionals with more than 423,000 members in over 160 countries around the world. Its objectives are the educational and technical advancement of electrical and electronic engineering, telecommunications, computer engineering and similar disciplines. History Origins ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).Set up by EC Regulation No. 2309/93 as the European Agency for the Evaluation of Medicinal Products, and renamed by EC Regulation No. 726/2004 to the European Medicines Agency, it had the acronym EMEA until December 2009. The European Medicines Agency does not call itself EMA either – it has no official acronym but may reconsider if EMA becomes commonly accepted (secommunication on new visual identity an). The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national medicine regulatory bodies. The hope was that this plan would not onl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not d ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Ministry Of Health, Labour And Welfare (Japan)
The is a cabinet level ministry of the Japanese government. It is commonly known as in Japan. The ministry provides services on health, labour and welfare. It was formed with the merger of the former Ministry of Health and Welfare or and the Ministry of Labour or . The Minister of Health, Labour and Welfare is a member of the Cabinet and is chosen by the Prime Minister, typically from among members of the Diet. Organization The ministry contains the following sections as of 2019: * The Minister's Secretariat (including the Statistics and Information Department) * The Health Policy Bureau * The Health Service Bureau * Pharmaceutical and Food Safety Bureau (including the Food Safety Department) * The Labour Standards Bureau (including the Industrial Safety and Health Department, Workers Compensation Department, and Workers' Life Department) * The Employment Security Bureau (including the Employment Measures for the Elderly and Persons with Disabilities Department) * The Hum ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmaceutical Inspection Convention And Pharmaceutical Inspection Co-operation Scheme
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are two international instruments between countries and pharmaceutical inspection authorities. The PIC/S is meant as an instrument to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the pharmaceutical industry. History The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the ''Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products''. The initial members comprised the 10 member countries of EFTA at that time. In the early 1990s it was realized that because of an incompatibility between the Convention and European law, it was not possible for new countries to be admitted as members of PIC. European law did not permit individual EU countries that were members of PIC to sign agreements with othe ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Quality
Quality may refer to: Concepts *Quality (business), the ''non-inferiority'' or ''superiority'' of something *Quality (philosophy), an attribute or a property *Quality (physics), in response theory *Energy quality, used in various science disciplines *Logical quality, philosophical categorization of statements *Service quality, comparison of expectations with performance in a service *Vapor quality, in thermodynamics, the ratio of mass of vapor to that of vapor and liquid *Data quality, refers to the condition of a set of values of qualitative or quantitative variables Practices *Quality assurance (QA) *Quality control (QC) Places *Quality, Kentucky, an unincorporated community Brands and enterprises *Quality Comics, an American comic book publisher between 1939 and 1956 *Quality Communications, a comic book publisher started in 1982 *Quality Records, a Canadian entertainment company Music * ''Quality'' (CDQ album), 2016 * ''Quality'' (Talib Kweli album), 2002 *"Quality", a song ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Engineering Concepts
Engineering is the use of scientific principles to design and build machines, structures, and other items, including bridges, tunnels, roads, vehicles, and buildings. The discipline of engineering encompasses a broad range of more specialized fields of engineering, each with a more specific emphasis on particular areas of applied mathematics, applied science, and types of application. See glossary of engineering. The term ''engineering'' is derived from the Latin ''ingenium'', meaning "cleverness" and ''ingeniare'', meaning "to contrive, devise". Definition The American Engineers' Council for Professional Development (ECPD, the predecessor of ABET) has defined "engineering" as: The creative application of scientific principles to design or develop structures, machines, apparatus, or manufacturing processes, or works utilizing them singly or in combination; or to construct or operate the same with full cognizance of their design; or to forecast their behavior under specific ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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