Active Pharmaceutical Ingredients: Developments, Manufacturing, and Regulation

Active Pharmaceutical Ingredients: Developments, Manufacturing, and Regulation

Author:Nusim, Stanley | PDF | 368 Pages | ISBN: 082470293X | 8,1 Mb | 2005 Year

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

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