Good engineering practice

Good Engineering Practice (GEP) is a set of guidelines and procedures that are used in the engineering field to ensure that products and systems are designed, developed, and maintained to high quality standards. GEP is a fundamental concept in the medical device and pharmaceutical industries, where it is often a regulatory requirement.

Overview

Good Engineering Practice is a professional and ethical obligation for engineers. It involves applying sound engineering principles and practices to ensure that products and systems are safe, effective, and reliable. GEP is often used in conjunction with other quality management systems, such as Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP).

Principles

The principles of Good Engineering Practice include:

• Safety: Ensuring that products and systems are safe to use and do not pose any unnecessary risks to users or the environment.
• Quality: Ensuring that products and systems meet specified requirements and are fit for their intended use.
• Reliability: Ensuring that products and systems perform consistently and reliably under normal operating conditions.
• Efficiency: Ensuring that products and systems are designed and developed in an efficient and cost-effective manner.

Application in the Medical and Pharmaceutical Industries

In the medical device and pharmaceutical industries, Good Engineering Practice is often a regulatory requirement. It is used to ensure that products and systems are designed, developed, and maintained to high quality standards. This includes ensuring that they are safe, effective, and reliable, and that they meet all relevant regulatory requirements.

In these industries, GEP is often used in conjunction with other quality management systems, such as Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP). These systems provide a framework for ensuring that products and systems are designed, developed, and maintained to high quality standards.

See Also

• Engineering ethics
• Quality management system
• Good Manufacturing Practice
• Good Laboratory Practice