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Good Practice
GxP is a general abbreviation for the "good practice" quality guidelines and regulations. The "x" stands for the various fields, including the pharmaceutical and food industries, for example good agricultural practice, or GAP. A "c" or "C" is sometimes added to the front of the initialism. The preceding "c" stands for "current." For example, cGMP is an acronym for "current good manufacturing practice". The term GxP is frequently used to refer in a general way to a collection of quality guidelines. Purpose The purpose of the GxP quality guidelines is to ensure a product is safe and meets its intended use. GxP guides quality manufacture in regulated industries including food, drugs, medical devices, and cosmetics. The most central aspects of GxP are Good Documentation Practices (GDP), which are expected to be 'ALCOA'': * Attributable: documents are attributable to an individual * Legible: they are readable * Contemporaneously Recorded: not dated in the past or the fut ...
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Quality (business)
In business, engineering, and manufacturing, quality – or high quality – has a pragmatic interpretation as the non-inferiority or superiority of something (goods or services); it is also defined as being suitable for the intended purpose (fitness for purpose) while satisfying customer expectations. Quality is a perceptual, conditional, and somewhat subjective attribute and may be understood differently by different people. Consumers may focus on the specification quality of a product/service, or how it compares to competitors in the marketplace. Producers might measure the conformance quality, or degree to which the product/service was produced correctly. Support personnel may measure quality in the degree that a product is reliable, maintainable, or sustainable. In such ways, the subjectivity of quality is rendered objective via operational definitions and measured with metrics such as proxy measures. Description There are many aspects of quality in a business conte ...
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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 ...
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Good Policing Practice
In most contexts, the concept of good denotes the conduct that should be preferred when posed with a choice between possible actions. Good is generally considered to be the opposite of evil and is of interest in the study of ethics, morality, philosophy, and religion. The specific meaning and etymology of the term and its associated translations among ancient and contemporary languages show substantial variation in its inflection and meaning, depending on circumstances of place and history, or of philosophical or religious context. History of Western ideas Every language has a word expressing ''good'' in the sense of "having the right or desirable quality" ( ἀρετή) and ''bad'' in the sense "undesirable". A sense of moral judgment and a distinction "right and wrong, good and bad" are cultural universals. Plato and Aristotle Although the history of the origin of the use of the concept and meaning of "good" are diverse, the notable discussions of Plato and Aristotle o ...
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Good Pharmacy Practice
In most contexts, the concept of good denotes the conduct that should be preferred when posed with a choice between possible actions. Good is generally considered to be the opposite of evil and is of interest in the study of ethics, morality, philosophy, and religion. The specific meaning and etymology of the term and its associated translations among ancient and contemporary languages show substantial variation in its inflection and meaning, depending on circumstances of place and history, or of philosophical or religious context. History of Western ideas Every language has a word expressing ''good'' in the sense of "having the right or desirable quality" ( ἀρετή) and ''bad'' in the sense "undesirable". A sense of moral judgment and a distinction "right and wrong, good and bad" are cultural universals. Plato and Aristotle Although the history of the origin of the use of the concept and meaning of "good" are diverse, the notable discussions of Plato and Aristotle o ...
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Good Pharmacovigilance Practice
In most contexts, the concept of good denotes the conduct that should be preferred when posed with a choice between possible actions. Good is generally considered to be the opposite of evil and is of interest in the study of ethics, morality, philosophy, and religion. The specific meaning and etymology of the term and its associated translations among ancient and contemporary languages show substantial variation in its inflection and meaning, depending on circumstances of place and history, or of philosophical or religious context. History of Western ideas Every language has a word expressing ''good'' in the sense of "having the right or desirable quality" ( ἀρετή) and ''bad'' in the sense "undesirable". A sense of moral judgment and a distinction "right and wrong, good and bad" are cultural universals. Plato and Aristotle Although the history of the origin of the use of the concept and meaning of "good" are diverse, the notable discussions of Plato and Aristotle o ...
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Good Participatory Practice
In most contexts, the concept of good denotes the conduct that should be preferred when posed with a choice between possible actions. Good is generally considered to be the opposite of evil and is of interest in the study of ethics, morality, philosophy, and religion. The specific meaning and etymology of the term and its associated translations among ancient and contemporary languages show substantial variation in its inflection and meaning, depending on circumstances of place and history, or of philosophical or religious context. History of Western ideas Every language has a word expressing ''good'' in the sense of "having the right or desirable quality" ( ἀρετή) and ''bad'' in the sense "undesirable". A sense of moral judgment and a distinction "right and wrong, good and bad" are cultural universals. Plato and Aristotle Although the history of the origin of the use of the concept and meaning of "good" are diverse, the notable discussions of Plato and Aristotle o ...
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Good Microbiological Practice
In most contexts, the concept of good denotes the conduct that should be preferred when posed with a choice between possible actions. Good is generally considered to be the opposite of evil and is of interest in the study of ethics, morality, philosophy, and religion. The specific meaning and etymology of the term and its associated translations among ancient and contemporary languages show substantial variation in its inflection and meaning, depending on circumstances of place and history, or of philosophical or religious context. History of Western ideas Every language has a word expressing ''good'' in the sense of "having the right or desirable quality" ( ἀρετή) and ''bad'' in the sense "undesirable". A sense of moral judgment and a distinction "right and wrong, good and bad" are cultural universals. Plato and Aristotle Although the history of the origin of the use of the concept and meaning of "good" are diverse, the notable discussions of Plato and Aristotle o ...
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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 manag ...
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Good Management Practice
In most contexts, the concept of good denotes the conduct that should be preferred when posed with a choice between possible actions. Good is generally considered to be the opposite of evil and is of interest in the study of ethics, morality, philosophy, and religion. The specific meaning and etymology of the term and its associated translations among ancient and contemporary languages show substantial variation in its inflection and meaning, depending on circumstances of place and history, or of philosophical or religious context. History of Western ideas Every language has a word expressing ''good'' in the sense of "having the right or desirable quality" ( ἀρετή) and ''bad'' in the sense "undesirable". A sense of moral judgment and a distinction "right and wrong, good and bad" are cultural universals. Plato and Aristotle Although the history of the origin of the use of the concept and meaning of "good" are diverse, the notable discussions of Plato and Aristotle o ...
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Good Laboratory Practice
In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products in development for human or animal health (including pharmaceuticals) through non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests. GLP was first introduced in New Zealand and Denmark in 1972, and later in the US in 1978 in response to the Industrial BioTest Labs scandal. It was followed a few years later by the Organization for Economic Co-operation and Development (OECD) Principles of GLP in 1992; the OECD has since helped promulgate GLP to many countries. GLP applies to non-clinical studies conducted for the assessment of the safety or efficacy of products in development (including pharmaceuticals) for people, animals, and the environment. GLP, a data and oper ...
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Good Hygiene Practice
In most contexts, the concept of good denotes the conduct that should be preferred when posed with a choice between possible actions. Good is generally considered to be the opposite of evil and is of interest in the study of ethics, morality, philosophy, and religion. The specific meaning and etymology of the term and its associated translations among ancient and contemporary languages show substantial variation in its inflection and meaning, depending on circumstances of place and history, or of philosophical or religious context. History of Western ideas Every language has a word expressing ''good'' in the sense of "having the right or desirable quality" ( ἀρετή) and ''bad'' in the sense "undesirable". A sense of moral judgment and a distinction "right and wrong, good and bad" are cultural universals. Plato and Aristotle Although the history of the origin of the use of the concept and meaning of "good" are diverse, the notable discussions of Plato and Aristotle o ...
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Good Horticultural Practice
In most contexts, the concept of good denotes the conduct that should be preferred when posed with a choice between possible actions. Good is generally considered to be the opposite of evil and is of interest in the study of ethics, morality, philosophy, and religion. The specific meaning and etymology of the term and its associated translations among ancient and contemporary languages show substantial variation in its inflection and meaning, depending on circumstances of place and history, or of philosophical or religious context. History of Western ideas Every language has a word expressing ''good'' in the sense of "having the right or desirable quality" ( ἀρετή) and ''bad'' in the sense "undesirable". A sense of moral judgment and a distinction "right and wrong, good and bad" are cultural universals. Plato and Aristotle Although the history of the origin of the use of the concept and meaning of "good" are diverse, the notable discussions of Plato and Aristotle o ...
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