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GxP
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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Automated Manufacturing Practice
Good automated manufacturing practice (GAMP) is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry. More specifically, the ISPE's guide ''The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture'' describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage of the manufacturing process. As a result, GAMP covers all aspects of production; from the raw materials, facility and equipment to the training and hygiene of staff. Standard operating procedures (SOPs) are essential for processes that can affect the quality of the finished product. A group of pharmaceutical professionals have banded toget ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Drug Distribution
The distribution of medications has special drug safety and security considerations. Some drugs require cold chain management in their distribution. The industry uses track and trace technology, though the timings for implementation and the information required vary across different countries, with varying laws and standards. Regulation Because governments regulate access to drugs, governments control drug distribution and the drug supply chain more than trade for other goods. Distribution begins with the pharmaceutical industry manufacturing drugs. From there, intermediaries in the public sector, private sector, and non-governmental organizations acquire drugs to provide them to other intermediaries. Eventually, the drugs reach different classes of consumers who use them. Good distribution practice (GDP) is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs intended for human consumption. It regulates the division and m ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 th ... [...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 ho ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Clinical Laboratory Practice
Good clinical laboratory practice (GCLP) is a GxP guideline for laboratory samples from clinical studies. Good clinical practice (GCP) does not define requirements for laboratories and good laboratory practice (GLP) focusses on pre-clinical analyses and not on human samples from clinical trials. The Research Quality Association (RQA) suggested in 2003 a guideline to close the gap. Later the 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 ... and the British Medicines and Healthcare products Regulatory Agency issued their own versions of a GCLP guideline. Literature * WHO Good Clinical Laboratory Practice (GCLP) * Stevens W. (2003) Good Clinical Laboratory Practice (GCLP): The need for a hybrid of Good Laboratory Practice and Good Clinical Practice guide ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Clinical Data Management Practice
Good clinical data management practice (GCDMP) is the current industry standards for clinical data management that consist of best business practice and acceptable regulatory standards. In all phases of clinical trials, clinical and laboratory information must be collected and converted to digital form for analysis and reporting purposes. The U.S. Food and Drug Administration and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use have provided specific regulations and guidelines surrounding this component of the drug and device development process. The effective, efficient and regulatory-compliant management of clinical trial data is an essential component of drug and device development. The Society for Clinical Data Management (SCDM) has created the Good Clinical Data Management Practices (GCDMP©) standard, a comprehensive document that provides guidance on accepted practices of clinical data management (CDM) ... [...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 manag ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Guidance Document
Administrative guidance is non-binding advice given by an administrative agency to the public regarding how best to comply with a particular law or regulation. It may also be referred to by terms such as "advice" or "recommendation." Guidance is often used to explain the objective or interpretation of a vague or nonspecific law or requirement. Types of guidance documents While guidance documents are not usually enforceable rules or requirements by themselves, they often define standards or expectations which are part of a rule or requirement. For example, a regulation might require adequate testing for relevant microorganisms in sterile containers and a guidance document would be used to explain what testing is adequate and which organisms are relevant. Guidance documents are also used to explain internal policies or practices to simplify an organization's interactions with other parties. For example, a guidance document could explain how to prepare a report or what informati ... [...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 p ... [...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 manag ... [...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 p ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |