ABSTRACT
I. INTRODUCTION The design and construction of API (active pharmaceutical ingredient) manufacturing facilities is one of the more challenging assignments in the engineering and construction business. The successful completion of a new API process facility is a function of accurate process definition, a robust project execution strategy, good engineering practices, sound construction techniques, and a wellplanned and documented start-up and validation plan. Early detailed process definition enables the project team to develop a comprehensive project execution strategy. The execution strategy outlines the engineering and construction methods for the project. The start-up and validation plan ensures regulatory compliance and a smooth transition from construction to operation. API production facilities are technically complex and expensive to design, construct, and validate. New facilities require sophisticated processing equipment, utilities, and support functions. Careful planning and good sound engineering are critical to assure that the investment in capital is managed wisely.
