ABSTRACT
Facility validation provides the documentation necessary to demonstrate that facilities, utility systems, and process equipment are operationally effective, safe, and efÞcient.
Figure 3.1 shows an example of a typical validation ßowchart for a pharmaceutical plant with the engineering and validation activities paralleled. The fundamental life-cycle approach to validation has been widely accepted internationally. The basic premise involves dividing the system into components or phases. The project validation life cycle follows a structured method to plan, design, implement, test, and operate a system from its conception to the termination of its use and decommissioning, or it may reenter the cycle with change and revalidation.
