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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