Guide to Good Validation Practice, 3rd Edition

Chapter 1: Executive Summary

Chapter 2: Introduction

• Validation in Research, Development, and Manufacturing
• The Regulatory Environment
• Types of Validation
• Corporate Implications of Non-compliance with GVP

Chapter 3: The Validation Master Plan

• Introduction
• Validation Master Plan Contents
• Responsibilities
• What is to be Validated?
  • Facilities
  • Systems
  • Processes
  • Analytical Methods
• Implementing the Plan
  • Design, Installation, and Operational Qualification
  • Performance Qualification and Validation
  • Documentation
• Change Control

Chapter 4: Facilities, Services, and Systems

• Facilities
  • Design and Construction
  • Utilities
• Validation of Special Systems
  • Water Systems: Purified and WFI
  • Sterilization Systems and Clean Steam Systems
  • Clean Rooms- Aseptic Work Areas
  • Computerized Systems

Chapter 5: Process Equipment and Pipe-work

• Introduction
• Design and DQ of Equipment and Piped Systems
• Installation, Operation, and Performance Qualification
• Validation of Cleaning Procedures
• Validation of Sterilization-In-Place Procedures

Chapter 6: Manufacturing Processes

• General Principles of Process Validation
• Guide to the Performance of Validations
• Special Processes- Validation Challenges
  • Glassware Washing Machines
  • Fermentor and Bioreactor Control
  • Chromatographic Separation
  • Transverse-flow Micro- and Ultrafiltration
  • Sterilizing Filtration
  • Virus Removal Processes
  • Aseptic Filling Operations
  • Lyophilizer (Freezedryer) Operation

Chapter 7: Analytical Methods for In-process and Final Quality Control

• Regulatory Requirements and Guidelines
• Qualification of Analytical Instruments and Equipment
• Test Method Validation
• Types of Analytical Procedures to be Validated
  • Test “Verification”, “Qualification” versus “Validation”
  • Physical and Chemical Analyses
  • Biological Assays

Chapter 8: Sample Checklists and Forms

• Check Lists for Plans and Protocols
• Equipment Qualification Report Forms

Chapter 9: References and Further Reading

• Access to Regulations on the Internet
• Validation and GMP Compliance Guidelines
  • U.S.A.
  • Canada
  • European Union
  • International Conference on Harmonization (ICH)
• Associations, Consultants and Publications

Chapter 10: Abstracts from International GLP/GMP/GCP Regulations

• Good Laboratory Practice
  • OECD PRINCIPLES OF GOOD LABORATORY PRACTICE*
  • (as revised in 1997)
  • USA Code of Federal Regulations
  • CANADA - “Guidelines for Good Manufacturing Practice”
  • JAPAN MHW Ordinance 16, March 123, 1999, Amended by MHW Ordinance #95, May 20, 2003

Chapter 11: Text of Key Validation Guidelines

• Process Validation Guidelines

• Exhibit 2.1 Definitions of “Process Validation”
• Exhibit 2.2 The Drug Development Cycle
• Exhibit 2.3 International "Practice" Regulations
• Exhibit 2.4 Regulations Specifically Concerning Validation
• Exhibit 2.5 Process Validation and the Product Development Cycle
• Exhibit 3.1 Typical “System Definition” Table for a VMP
• Exhibit 3.2 Derivation of Validation Plans/Protocols
• Exhibit 3.3 Validation Protocol Contents List
• Exhibit 4.1 Factors Determining User Requirements Specifications
• Exhibit 4.2 Standards for Pharmaceutical Water Grades
• Exhibit 4.3 Schematic of WFI System
• Exhibit 4.4 Clean Room Classes According to FS 209E
• Exhibit 4.5 EUDRA Clean Room Specifications
• Exhibit 4.6 ISO 14644-1 Standard
• Exhibit 4.7 EU Microbiological Monitoring of Clean Areas
• Exhibit 6.1 Validation and Product Development
• Exhibit 6.2 Process Validation Life Cycle
• Exhibit 6.3 Terminology of Process Validation
• Exhibit 6.4 Calculation of Process Capability
• Exhibit 6.5 Washer Qualification Plan
• Exhibit 6.6 Control of a Cell Culture Bioreactor
• Exhibit 6.7 Typical Flow/Pressure Graphs for TFF Membranes
• Exhibit 6.8 Parameters Affecting Sterilizing Filter Performance
• Exhibit 6.9 Viruses Commonly Used in Clearance Studies
• Exhibit 7.1 Basis of Questionnaire for Vendor Qualification
• Exhibit 7.2 The Characteristics of a Calibration Curve
• Exhibit 7.3 Parameters Applicable to Different Analytical Procedures
• Exhibit 7.4 Analytical Methods Applied to Biological Products
• Exhibit 7.5 Calculation of Intra-assay and Inter-assay Precision
• Exhibit 7.6 Three-dimensional Factorial Test Validation Plan
• Exhibit 11.1 FDA Guideline on General Principles of Process Validation
• Exhibit 11.2 EU European Commission
• Exhibit 11.3 ORA Compliance Policy Guide
• Exhibit 11.4 Guidance to 21CFR11
• Exhibit 11.5 FDA/ICH Analytical Method Validation Q2A & B
• Exhibit 11.6 FDA Bioanalytical Method Validation