ABSTRACT
Properly designed manufacturing facilities are critical to the successful approval of biotechnology-derived (biotech) products. The Food and Drug Administration (FDA) has established regulations that govern establishments used to manufacture biological products. These include the Code of Federal Regulations (CFR), Title 21, Part 600, Subpart B Establishment Standards [1] and Parts 210 and 211 current good manufacturing practice (CGMP) regulations [2]. These regulations were established prior to the advent of biotech products. The intent of the regulations is, however, applicable to facilities designed to produce biotech products.
