Active Pharmaceutical Ingredients

Filling a gap in the literature, this guidecovers all the essential information required to effectively plan and execute the manufacturing of quality APIsstudies the process development task, as well as plant design, construction, and operationreviews the latest regulatory standards in this rapidly changing marketdetails validation procedures for bulk pharmaceutical chemicalsdiscusses the unique aspects of the quality function in the API industry 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. This guide 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.