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.

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

This pharmacology-related article is a stub. You can help Wikipedia by expanding it.