ABSTRACT

The design and construction of active pharmaceutical ingredient (API) facilities is an extremely complex and challenging undertaking. The time required to design construct and validate a facility to manufacture API products must be balanced against marketing and regulatory considerations. A firm may be required early in the drug development process to start investing in new production facilities or enhancing existing capacity so that a product can be produced for testing, and eventually for full-scale production to meet the market demand. An API manufacturer must develop a comprehensive

process=facility design and construction execution strategy to ensure achievement of all regulatory, cost, and market objectives for the compound.