Facility validation : theory, practice, and tools

Contents Chapter 1 The Regulatory Requirements for Validation in the Pharmaceutical Industry 1.1 The Regulatory Requirements of Good Manufacturing Practice (GMP) 1.1.1 Buildings and Facilities 1.1.1.1 GMP Principles 1.1.2 Equipment 1.1.2.1 GMP Principles 1.2 The Relationship between Validation and GMP 1.2.1 Compliance 1.2.2 Quality Assurance 1.2.3 Economics 1.3 The Impact of Changing Regulations on the Scope and Extent of Validation 1.4 The Future of GMP References Chapter 2 The Fundamentals and Essentials of Validation 2.1 Validation Concepts, Definitions, and Terminology 2.2 The Philosophy and Key Principles of Validation 2.2.1 The Life-Cycle Approach to Validation 2.2.2 Qualification Practices 2.3 Organizing and Planning for Validation 2.3.1 Organizing for Validation 2.3.2 Planning for Validation 2.4 The Essential Validation Disciplines References Chapter 3 The Practice of Facility Validation 3.1 A Typical Life-Cycle Approach for the Qualification and Validation of a Pharmaceutical Manufacturing Facility 3.1.1 The Requirements and Specification Phase 3.1.2 Validation Planning 3.1.3 The Validation Project Team 3.1.4 Facility Systems GMP Audit, Design Qualification, and Impact Assessment 3.1.5 Factory Acceptance Tests (FATs) and Predelivery Inspections (PDIs) © 2004 by CRC Press LLC ???? 3.1.6 Commissioning 3.1.7 Installation and Operational Qualification (IQ/OQ) 3.1.8 Performance Qualification (PQ) 3.1.9 Related Compliance Programs 3.1.10 Plant Release and Start-Up 3.1.11 Periodic Review, Change Control, and Revalidation References Chapter 4 Twenty Tools Recommended for Facility Validation 4.1 Common Problems Associated with Facility Validation 4.2 Good Validation Practice 4.3 Step 1: Structure the Project Team Appropriately; Define Functions, Roles, and Responsibilities 4.3.1 Project Team Structure 4.3.2 Project Team Function 4.3.3 Project Team Roles and Responsibilities 4.4 Step 2: Get Project Team Buy-In 4.5 Step 3: Educate Project Team 4.6 Step 4: Involve Quality Assurance 4.7 Step 5: Encourage Greater End-User/Stakeholder Participation 4.8 Step 6: Conduct Quality Compliance Audits of Prospective Vendors 4.9 Step 7: Give Vendors the Information Needed to Succeed 4.10 Step 8: Define Validation Scope; Conduct Impact Analysis Early 4.11 Step 9: Develop a Robust Validation Master Plan 4.12 Step 10: Integrate Validation Schedules into the Overall Project Schedule 4.13 Step 11: Adopt Formal Commissioning Procedures 4.14 Step 12: Standardize Validation Approach SOPs/Guidelines; Educate Validators 4.15 Step 13: Avoid Duplicate Testing; Integrate Commissioning with Validation Activities 4.16 Step 14: Formalize Turn-Over Process and Turn-Over Package Documentation Requirements 4.17 Step 15: Begin Facility-Related Compliance Programs Early 4.18 Step 16: Enhance Documentation and Documentation Management Practices 4.19 Step 17: Conduct Periodic Design and Construction Reviews 4.20 Step 18: Hand-Over and Train End Users in Validated Systems 4.21 Step 19: Develop a Revalidation Strategy to Maintain a Validated System or Equipment 4.22 Step 20: Continuously Improve and Maintain Validation Practices; Reapply Lessons Learned from Previous Projects References © 2004 by CRC Press LLC ???? Chapter 5 Good Validation Practices 5.1 Benefits of Following Good Validation Practices 5.2 Consequences of Not Following Good Validation Practices 5.2.1 Total Validation Duration and Costs References Chapter 6 Conclusions and Future Directions References Chapter 7 Glossary of Definitions and Terms Associated with Validation