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How to Validate a Pharmaceutical Process - 1st Edition - ISBN: 9780128041482, 9780128096536

How to Validate a Pharmaceutical Process

1st Edition

Author: Steven Ostrove
eBook ISBN: 9780128096536
Paperback ISBN: 9780128041482
Imprint: Academic Press
Published Date: 7th June 2016
Page Count: 218
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Table of Contents

About the Expertise in the Pharmaceutical Process Technology Series

  • Format
  • Subject Matter
  • Target Audience

Section I: Introduction to Process Validation

  • Chapter 1. Introduction to Process Validation (PV)
    • Abstract
    • Defining Process Validation (PV)
    • Legacy Products
    • Stages of PV
    • Notes
  • Chapter 2. A Brief Review of the Regulations
    • Abstract
    • Notes
  • Chapter 3. The Validation Life Cycle and Change Control
    • Abstract
    • Life Cycle Approach
    • The Role of Change Control
    • Types of Changes
    • The Change Control Process
    • Notes

Section II: Stage I—Process Development

  • Chapter 4. Getting Started
    • Abstract
    • Before It All Starts
    • Getting Started (After the Equipment Specifications)
    • The Validation Master Plan
    • Standard Operating Procedures (SOPs) Preparation
    • Quality Programs
    • Training
    • Basic Risk Approach
    • Putting it Together
    • Notes
  • Chapter 5. Basic Equipment and Utility Qualification
    • Abstract
    • Introduction
    • Determining the Level of Qualification
    • Factory Acceptance Test and Site Acceptance Test
    • Commissioning
    • Qualification Protocols—Installation Qualification (IQ) and Operational Qualification (OQ)
    • Laboratory Equipment Qualification (EQ)
    • Qualification Protocol Execution
    • Notes
  • Chapter 6. Computers and Automated Systems
    • Abstract
    • Introduction
    • General Considerations
    • Specific Systems
    • Part 11
    • Notes

Section III: Stage II—Process Development

  • Chapter 7. Process Development
    • Abstract
    • Preliminaries
    • Development
    • Risk Assessment
    • Process Parameters
    • Setting Process Limits
    • Next Steps
    • Notes
  • Chapter 8. The Process Validation Protocol—PPQ
    • Abstract
    • Introduction
    • Setting Protocol Test Ranges
    • Preparing the Protocol
    • Executing the Protocol
    • Notes
  • Chapter 9. Dealing With Deviations
    • Abstract
    • The Investigation
    • Notes

Section IV: Stage III—Continued Process Verification

  • Chapter 10. Stage III—Collection and Evaluating Production Data
    • Abstract
    • General Approach
    • Legacy Products
    • Stage III—Continued Process Verification (CPV)
    • Statistical Process Control and Control Charts
    • Notes

Section V: Other Related Activities

  • Chapter 11. Cleaning and Facility Qualification
    • Abstract
    • Facility Design
    • Introduction to Cleaning
    • General Cleaning Considerations
    • Facility Design and Cleaning
    • Equipment Cleaning
    • Other Cleaning Considerations
    • Notes

Terms and Definitions

Appendix A. 21 CFR 211

Appendix B. Example—Short Change Control Form

Appendix C. Additional ICH and FDA Guidelines

  • Important ICH and FDA Guidelines


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.

Key Features

  • Thoroughly referenced and based on the latest research and literature
  • Illustrates the most common issues related to developing and implementing a sustainable process validation program and provides examples on how to be successful
  • Covers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more


Pharmaceutical personnel, including research and development professionals, pharmaceutical consultants, team leaders and department heads


No. of pages:
© Academic Press 2016
7th June 2016
Academic Press
eBook ISBN:
Paperback ISBN:

Ratings and Reviews

About the Author

Steven Ostrove

Dr. Ostrove has over 30 years of experience in validation compliance, quality assurance, and regulatory affairs. In addition, he has developmental and process expertise in mammalian cell culture and separation technology. His general pharmaceutical experience includes sterile techniques (Aseptic processing), Process Validation, Cleaning and Sterilization Validation, Packaging Systems, Process Development and Process Scale-up. He also has industry experience with the development and validation of PC and PLC-based computer control systems for the biotech and pharmaceutical markets, guidance on system optimization for CIP/SIP and has led teams for the review of all GMP documents starting with their preparation (e.g., protocols, SOPs, and validation master plans). Dr. Ostrove has worked on several consent degree remediation and audit teams and his experience covers both EU and US regulations. He is the author of the Elsevier short format book How to Validate a Pharmaceutical Process (Jun 2016, 9780128041482).

Affiliations and Expertise

Ostrove Associates, Inc. Elizabeth, NJ, USA