Main description:

How to Validate a Pharmaceutical Process provides a "how to" approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the "why" is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation.

Contents:

1. Introduction

Section I What is Process Validation and Why do Process Validation? 2. Defining Process Validation 3. Brief Review of the Regulations and Guidelines 4. The Role of Change Control

Section II Stage I - Process Development 5. Starting the Process Validation Program 6. Equipment and Utility Qualification 7. Dealing with Computers and Automation Validation 8. Process Development

Section II Process Qualification 9. The Process Validation Protocol 10. Dealing with Deviations

Section III Continued Process Verification 11. Collecting and Evaluating Production 12. Use of Statistical Process Control - pPk, Pk, cPk, cP

Section IV Other Related Activities 13. Cleaning- Verification to Validation 14. Facility Qualification