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How to Validate a Pharmaceutical Process
1st Edition - June 7, 2016
Author: Steven Ostrove
Paperback ISBN:9780128041482
9 7 8 - 0 - 1 2 - 8 0 4 1 4 8 - 2
eBook ISBN:9780128096536
9 7 8 - 0 - 1 2 - 8 0 9 6 5 3 - 6
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… Read more
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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.
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
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
No. of pages: 218
Language: English
Published: June 7, 2016
Imprint: Academic Press
Paperback ISBN: 9780128041482
eBook ISBN: 9780128096536
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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).