Facility Design for Validation

The design, construction, and start-up of pharmaceutical and biopharmaceutical facilities governed by Current Good Manufacturing Practices (CGMP) regulations requires a different approach than might be applied for any other manufacturing facility projects. This chapter aims to emphasize the importance of both good design and good project management practices to achieve the ultimate goals of a CGMP project. It looks at projects in general and discusses the relationship between project activities, deliverables, and validation, where validation is an essential element of quality. The Good Manufacturing Practices (GMP) Project Roadmap shown is a generic version provided for illustration and guidance of further discussion on project management and validation. In addition, process validation expertise is important in reviewing and approving designs and key GMP documents included in the Roadmap. The work of validation continues in parallel with the work of the facility project through the detailed design and construction phases.