Good Engineering Practice
Encyclopedia
"Good engineering practice" or "GEP" is a term applied to engineering and technical activities to ensure that a company manufactures products of the required quality as expected by the relevant regulatory authorities. Good engineering practices are to ensure that the engineering or software development methodology generates deliverables that support the requirements for qualification or validation. Good engineering practices are applied to all industries that require engineering, they do not solely apply to the pharmaceutical industry.
See also
- GxPGxPGxP is a general term for Good Practice quality guidelines and regulations. These guidelines are used in many fields, including the pharmaceutical and food industries....
- Good manufacturing practiceGood Manufacturing Practice"Good manufacturing practice" or "GMP" are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods,...
(GMP) - Best practiceBest practiceA best practice is a method or technique that has consistently shown results superior to those achieved with other means, and that is used as a benchmark...
- American National Standards InstituteAmerican National Standards InstituteThe American National Standards Institute 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...
(ANSI) - Institute of Electrical and Electronics EngineersInstitute of Electrical and Electronics EngineersThe Institute of Electrical and Electronics Engineers is a non-profit professional association headquartered in New York City that is dedicated to advancing technological innovation and excellence...
(IEEE) - European Medicines AgencyEuropean Medicines AgencyThe European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
(EMEA) - Food and Drug AdministrationFood and Drug AdministrationThe Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) - Ministry of Health, Labour and Welfare (Japan)Ministry of Health, Labour and Welfare (Japan)The ' is a cabinet level ministry of the Japanese government. It is commonly known as Kōrō-shō in Japan. This ministry provides regulations on maximum residue limits for agricultural chemicals in foods, basic food and drug regulations, standards for foods, food additives, etc.It was formed with...
- Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation SchemePharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation SchemeThe Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme are two international instruments between countries and pharmaceutical inspection authorities...
(PIC/S)