Active Pharmaceutical Ingredients
Development, Manufacturing, and Regulation
Series: Drugs and the Pharmaceutical Sciences; 205;
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58 763 Ft
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Product details:
- Edition number 1
- Publisher CRC Press
- Date of Publication 25 May 2005
- ISBN 9780824702939
- Binding Hardback
- No. of pages368 pages
- Size 228x152 mm
- Weight 613 g
- Language English
- Illustrations 48 Illustrations, black & white; 15 Tables, black & white 0
Categories
Short description:
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.
MoreLong description:
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.
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.
Table of Contents:
Introduction. Process Development. Technology Transfer. Plant Design & Construction. Regulatory Requirements. Process Validation. Quality Assurance and Control. Plant Operations. Materials Management. Plant Maintenance
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