Good engineering practice
Good engineering practice (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.{{Cite web|title=Good Practice Guide: Good Engineering Practice|url=https://ispe.org/publications/guidance-documents/good-practice-guide-good-engineering-practice|access-date=2020-09-12|website=ISPE {{!}} International Society for Pharmaceutical Engineering|language=en}}
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)
References
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Sources
- [https://web.archive.org/web/20110929185235/http://www.ispe.org/galleries/reg-new-gallery/Qualfor21stCentury.pdf Risk-Based Qualification for the 21st Century]
- [https://web.archive.org/web/20080302115658/http://www.ispe.org/page.ww?name=Welcome+to+the+ISPE+GAMP+COP§ion=GAMP+COP ISPE GAMP COP]
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