• Source: 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.




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






Sources


Risk-Based Qualification for the 21st Century
ISPE GAMP COP

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