Preface
1 General Provisions
1.1 Purpose
1.2 Scope
2 Normative Reference Documents
3 Terms and Abbreviations
3.1 Terms
3.2 Abbreviations
4 Foundation of Pollution Control Strategy
4.1 Scientific Knowledge
4.1.1 Production System Knowledge
4.1.2 Product and Process Knowledge
4.1.3 Microbial, Pyrogen/Endotoxin, and Particulate Matter Knowledge
4.2 Quality Risk Management Concept-Based Approach
4.3 Continuous Improvement of Quality Management System
4.4 Quality Culture and Personnel Awareness
5 Application of Quality System in Pollution Control Strategy
5.1 Risk Management
5.2 Change Control
5.3 Investigation
5.4 Corrective and Preventive Actions (CAPA)
5.5 Quality Review and Trend Analysis
5.6 Supplier Management
5.7 Quality Control
6 Formulation of Pollution Control Strategy
7 Control Elements of Pollution Control Strategy
7.1 Facilities and Plant
7.1.1 Design of Facilities and Plants
7.1.2 Usage, Maintenance, and Repair of Facilities and Plants
7.1.3 Daily Monitoring of Facilities and Plants
7.1.4 Periodic Review of Facilities and Plants
7.2 Equipment
7.2.1 Design of Equipment
7.2.2 Usage, Maintenance, and Repair of Equipment
7.2.3 Periodic Review of Equipment
7.3 Personnel
7.3.1 Permission Control
7.3.2 Hygiene and Health Conditions of Personnel
7.3.3 Cleanroom Garments and Changeover Process
7.3.4 Training
7.3.5 Authorization for Changeover
7.3.6 Maximum Number of Personnel
7.3.7 Monitoring of Cleanroom Garments
7.3.8 Recertification of Changeover Authorizations
7.3.9 Revocation of Personnel Qualifications
7.3.10 Aseptic Behavior Requirements
7.4 Utility Systems
7.4.1 Design
7.4.2 Validation
7.4.3 Daily Monitoring
7.4.4 Regular Maintenance
7.4.5 Data Trend Analysis Review
7.4.6 Continuous Improvement (Deviation, Change)
7.4.7 Recovery after System Shutdown
7.5 Materials
7.5.1 Material Selection
7.5.2 Material Supply
7.5.3 Acceptance and Storage
7.5.4 Sampling, Testing, and Release
7.5.5 Transportation and Use
7.5.6 Trend Analysis
7.6 Products and Processes
7.6.1 Non-Final Sterilization Process
7.6.2 Final Sterilization Process
7.7 Environmental Monitoring
7.7.1 Overview
7.7.2 Design of Environmental Monitoring Workflow
7.7.3 Performance Confirmation and Periodic Reconfirmation of Environmental Monitoring
7.7.4 Continuous Evaluation of Environmental Monitoring
7.7.5 Continuous Improvement (Deviation, Change)
7.7.6 Considerations for Environmental Monitoring during Environmental Restoration
7.8 Mutual Connections Among Control Elements in the Pollution Control Strategy
8 Monitoring and Effectiveness Analysis of Pollution Control Strategy
9 Appendix
9.1 Example Analysis of Risk Identification Related to Pollution Control
9.2 Reference Examples of Pollution Control Strategy Documents
9.3 Reference Examples of Effectiveness Analysis for Pollution Control Strategies
9.4 Pollution Control Strategy for Freeze-Drying Process
9.5 FFS Process Pollution Control Strategy
9.6 Pollution Control Strategy for Biologic Product Raw Material Production Process
10 References, Guidelines, and Literature