The objective of the Gentech Process Engineering Design Criteria and Guidelines for GMP is to provide a consistent framework for approaching designs of new facilities, modifications of existing facilities and or retrofits. This encompasses the intent of providing a facility that will be suitable for manufacturing food and other ingredients that require clean design. It is not meant, however, to take the place of detailed design and specifications that must be prepared for each specific application nor the application of good engineering design and judgment and local codes. This approach, therefore, is a guideline for design principles and shall be used as such. The concepts that need to be in the forefront of the minds of the design professionals should incorporate these guidelines as well as several other principles, as discussed below: