How to Validate a Pharmaceutical Process

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