ABSTRACT
In the United States, the Food, Drug, and Cosmetic Act requires that pharmaceutical and biopharmaceutical products be manufactured in accordance with the current Good Manufacturing Practice (GMP) Regulations for Finished Pharmaceuticals, under 21 CFR Parts 210 and 211. The guidelines that appear in the various subparts of these regulations define the requirements for process validation and the concepts that make the design and construction of biotech facilities such a challenge to execute. Any company involved in pharmaceutical production, including firms that produce clinical trial materials, is subject to GMP regulations.
