Ostrove Steven. How to Validate a Pharmaceutical Process

Academic Press, 2016. — 218 p. — ISBN: 9780128096536; ISBN: 9780128041482.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 FeaturesThoroughly 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.Author Biography.About the Expertise in the Pharmaceutical Process Technology Series •Format.
Subject Matter.Target AudienceIntroduction to Process Validation
Introduction to Process Validation (PV)
Abstract.
Defining Process Validation (PV).
Legacy Products.
Stages of PV.A Brief Review of the Regulations
Abstract.The Validation Life Cycle and Change Control
Abstract.
Life Cycle Approach.
The Role of Change Control.
Types of Changes.
The Change Control Process.Stage I — Process Development
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.Basic Equipment and Utility Qualification
Abstract.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.Computers and Automated Systems
Abstract.General Considerations.
Specific Systems.Stage II — Process Development
Process Development
Abstract.
Preliminaries.
Development.
Risk Assessment.
Process Parameters.
Setting Process Limits.
Next Steps.The Process Validation Protocol — PPQ
Abstract.Setting Protocol Test Ranges.
Preparing the Protocol.
Executing the Protocol.Dealing With Deviations
Abstract.
The Investigation.Stage III — Continued Process Verification
Stage III — Collection and Evaluating Production Data
Abstract.
General Approach.
Legacy Products.
Stage III — Continued Process Verification (CPV).
Statistical Process Control and Control Charts.Other Related Activities
Cleaning and Facility Qualification
Abstract.
Facility Design.
Introduction to Cleaning.
General Cleaning Considerations.
Facility Design and Cleaning.
Equipment Cleaning.
Other Cleaning Considerations.Appendix A. 21 CFR 211.
Appendix B. Example — Short Change Control Form.
Appendix C. Additional ICH and FDA Guidelines •Important ICH and FDA Guidelines.