Focusing on the three most critical components that successfully bring an API to market-process development, manufacturing, and
governmental regulation and approval-this reference serves as a step-by-step guide to the planning and clear understanding of the bulk manufacturing of APIs. It offers current and timely discussions of the process development cycle, design engineering, the approval process, quality control and
assurance, and validation, as well as plant manufacturing activities including
materials management, maintenance, and safety. Filling a gap in the literature, this guide covers all the essential information required to effectively plan and execute manufacturing APIs.
