Good engineering practice explained

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.^[1]

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 Century
• ISPE GAMP COP

Notes and References

1. Web site: Good Practice Guide: Good Engineering Practice. 2020-09-12. ISPE International Society for Pharmaceutical Engineering. en.