Regulatory Considerations of Biomanufacturing Facilities

Abstract Throughout the design process, architectural engineer of biopharmaceutical facility must be cognizant of the various global and regional regulatory statutes, related regulations, and expectations that are applicable to the facility's design, form, and intended function. Regulatory aspects must be clearly understood, including design and construction features, open and closed processing and related area classifications, plumbing and lighting, equipment suitability, and the flow of personnel, equipment, and materials. The chapter offers a regulatory “tool box” for a design team of a multiproduct biopharmaceutical facility. It provides an overview of US and European regulations and guidelines considering the quality systems and control strategies along with bioburden control, and their potential impact on the design and operation of a facility. A synopsis of the Compliance Program guidelines used by FDA (Food and Drug Administration) investigators who inspect biopharmaceutical facilities and the common FDA 483 observations are included. The information given in this chapter should not be considered as all inclusive, but rather as a basic foundation in the attempt to achieve regulatory compliance during facility design.