Good Engineering Practice
- Good Engineering Practice
Good Engineering Practice or GEP is applied to engineering and technical activities to ensure that a company manufactures products of the required quality as expected by the 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 in the pharmaceutical industry.
ee 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)
ources
* [http://www.ispe.org/galleries/reg-new-gallery/Qualfor21stCentury.pdf Risk-Based Qualification for the 21st Century]
* [http://www.ispe.org/page.ww?section=GAMP+COP&name=Welcome+to+the+ISPE+GAMP+COP ISPE GAMP COP]
Wikimedia Foundation.
2010.
Look at other dictionaries:
Good Manufacturing Practice — Unter Good Manufacturing Practice (engl., kurz GMP, dt. „Gute Herstellungspraxis“) versteht man Richtlinien zur Qualitätssicherung der Produktionsabläufe und umgebung in der Produktion von Arzneimittel und Wirkstoffen, aber auch bei Lebens und… … Deutsch Wikipedia
Good Automated Manufacturing Practice — (GAMP) is a technical sub committee, known as a COP (Community Of Practice) of the International Society for Pharmaceutical Engineering (ISPE). The goal of the community is to promote the understanding of the regulation and use of automated… … Wikipedia
Engineering — The Watt steam engine, a major driver in the Industrial Revolution, underscores the importance of engineering in modern history. This model is on display at the main building of the ETSIIM in Madrid, Spain. Engineering is the discipline, art,… … Wikipedia
Engineering ethics — is the field of applied ethics which examines and sets standards for engineers obligations to the public, their clients, employers and the profession. This article addresses the subject for both professional engineers and other… … Wikipedia
Topic outline of engineering — For a more comprehensive list, see the List of engineering topics. Engineering is the practice and method of applying scientific and empirical knowledge to the service of humanity, and is distinct from the physical sciences, which are studies of… … Wikipedia
Outline of engineering — See also: Index of engineering articles The following outline is provided as an overview of and topical guide to engineering: Engineering – discipline, art, skill and profession of acquiring and applying scientific, mathematical, economic, social … Wikipedia
Engineering economics — Engineering economics, previously known as engineering economy, is a subset of economics for application to engineering projects. Engineers seek solutions to problems, and the economic viability of each potential solution is normally considered… … Wikipedia
Engineering tolerance — is the permissible limit or limits of variation in a physical dimension, a measured value or physical property of a material, manufactured object, system, or service, other measured values (such as temperature, humidity, etc.). in engineering and … Wikipedia
Good Automated Manufacturing Practice — Der „Good Automated Manufacturing Practice Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture“ (kurz: GAMP) wurde 1995 vom UK Pharmaceutical Industry Computer Validation Forum veröffentlicht. Dieser Leitfaden hat… … Deutsch Wikipedia
Good Automated Manufacturing Practice (GAMP) — Der „Good Automated Manufacturing Practice (GAMP) Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture“ wurde 1995 vom UK Pharmaceutical Industry Computer Validation Forum veröffentlicht. Dieser Leitfaden hat sich zum… … Deutsch Wikipedia
