ABSTRACT
Facilities that support the manufacturing, testing, storage, and dis tribution of medical products must be designed and constructed in a manner that protects the product and its processing. Facilities es tablish physical space and environmental conditions within that space. The required characteristics for any physical environment are determined by the purpose or intended use of the facility. Fa cility qualification studies should demonstrate that the facility is able to meet its intended use in the hands of the intended users of the facility.
