ABSTRACT

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

chapter 1|8 pages

Introduction

chapter 2|84 pages

Process Development

chapter 5|36 pages

Regulatory Affairs

chapter 6|32 pages

Validation

chapter 8|20 pages

Plant Operations

chapter 9|18 pages

Materials Management

chapter 10|12 pages

Plant Maintenance