Active Pharmaceutical Ingredients: Developments, Manufacturing, and Regulation
Category: Medical
Tag: Medical/Medicine
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Description
Active Pharmaceutical Ingredients is a step-by-step guide to the planning and clear understanding of the bulk manufacturing of APIs.
Features of Active Pharmaceutical Ingredients:
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-Active Pharmaceutical Ingredients is a step-by-step guide to the planning and clear understanding of the bulk manufacturing of APIs.
Active Pharmaceutical Ingredients 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.
Contents
Process Development
Technology Transfer
Plant Design & Construction
Regulatory Requirements
Process Validation
Quality Assurance and Control
Plant Operations
Materials Management
Plant Maintenance
Book Info:
Published in 2005
Author Nusim, Stanley
ISBN 082470293X Size 8.10MB
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