How to Validate a Pharmaceutical Process

Academic Press
  • 1. Auflage
  • |
  • erschienen am 7. Juni 2016
  • |
  • 218 Seiten
E-Book | ePUB mit Adobe DRM | Systemvoraussetzungen
978-0-12-809653-6 (ISBN)

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

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.
  • Englisch
  • San Diego
  • |
  • USA
Elsevier Science
  • 5,82 MB
978-0-12-809653-6 (9780128096536)
0-12-809653-5 (0128096535)
weitere Ausgaben werden ermittelt
  • Front Cover
  • How to Validate a Pharmaceutical Process
  • Copyright Page
  • Dedication
  • Contents
  • Author Biography
  • Preface
  • Acknowledgment
  • About the Expertise in the Pharmaceutical Process Technology Series
  • Format
  • Subject Matter
  • Target Audience
  • I: Introduction to Process Validation
  • 1 Introduction to Process Validation (PV)
  • Defining Process Validation (PV)
  • Legacy Products
  • Stages of PV
  • Notes
  • 2 A Brief Review of the Regulations
  • Notes
  • 3 The Validation Life Cycle and Change Control
  • Life Cycle Approach
  • The Role of Change Control
  • Types of Changes
  • The Change Control Process
  • Notes
  • II: Stage I-Process Development
  • 4 Getting Started
  • Before It All Starts
  • Example
  • 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
  • 5 Basic Equipment and Utility Qualification
  • Introduction
  • Determining the Level of Qualification
  • Factory Acceptance Test and Site Acceptance Test
  • Commissioning
  • Qualification Protocols-Installation Qualification (IQ) and Operational Qualification (OQ)
  • Performance Qualification
  • Laboratory Equipment Qualification (EQ)
  • Qualification Protocol Execution
  • Reports
  • Calibration and Preventive Maintenance Programs
  • Notes
  • 6 Computers and Automated Systems
  • Introduction
  • General Considerations
  • Documentation
  • Testing
  • Basic CSV-Black Box-Gray Box-White Box Testing
  • Computer Life Cycle
  • Specific Systems
  • Microprocessors
  • Programmable Logic Controllers (PLCs)
  • Personal Computers
  • Networks
  • Supervisory Control and Data Acquisition (SCADA)
  • Distributed Control Systems (DCS)
  • Part 11
  • Notes
  • III: Stage II-Process Development
  • 7 Process Development
  • Preliminaries
  • Development
  • Risk Assessment
  • Process Parameters
  • Setting Process Limits
  • Next Steps
  • Notes
  • 8 The Process Validation Protocol-PPQ
  • Introduction
  • Setting Protocol Test Ranges
  • Preparing the Protocol
  • Executing the Protocol
  • Sampling Plans
  • Recording the Results
  • The Validation Report
  • Notes
  • 9 Dealing With Deviations
  • The Investigation
  • Notes
  • IV: Stage III-Continued Process Verification
  • 10 Stage III-Collection and Evaluating Production Data
  • General Approach
  • Legacy Products
  • Stage III-Continued Process Verification (CPV)
  • Statistical Process Control and Control Charts
  • Notes
  • V: Other Related Activities
  • 11 Cleaning and Facility Qualification
  • 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
  • Index
  • Back Cover

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