Pharmacy & Pharmaceutical Research
- Filling a gap in the literature, this guide
- covers all the essential information required to effectively plan and execute the manufacturing of quality APIs
- studies the process development task, as well as plant design, construction, and operation
- reviews the latest regulatory standards in this rapidly changing market
- details validation procedures for bulk pharmaceutical chemicals
- discusses 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.