Downstream Processing

  1. Quality and Regulatory Aspects
    1. Good Manufacturing Practices
      1. GMP Principles
        1. Facility Requirements
          1. Design and Layout
            1. Environmental Controls
              1. Utilities
              2. Equipment Qualification
                1. Design Qualification
                  1. Installation Qualification
                    1. Operational Qualification
                      1. Performance Qualification
                      2. Personnel Requirements
                        1. Training Programs
                          1. Competency Assessment
                        2. Quality by Design
                          1. QbD Principles
                            1. Critical Quality Attributes
                              1. Identification and Definition
                                1. Acceptance Criteria
                                2. Critical Process Parameters
                                  1. Identification and Control
                                    1. Control Strategy
                                    2. Design Space
                                      1. Development and Validation
                                        1. Regulatory Flexibility
                                        2. Control Strategy
                                          1. Process Controls
                                            1. Material Controls
                                              1. Facility Controls
                                            2. Process Validation
                                              1. Validation Principles
                                                1. Process Performance Qualification
                                                  1. Protocol Development
                                                    1. Execution and Documentation
                                                      1. Statistical Analysis
                                                      2. Continued Process Verification
                                                        1. Ongoing Monitoring
                                                          1. Trend Analysis
                                                          2. Analytical Method Validation
                                                            1. Method Development
                                                              1. Validation Parameters
                                                                1. Method Transfer
                                                              2. Impurity Control
                                                                1. Host Cell Proteins
                                                                  1. Detection Methods
                                                                    1. Removal Strategies
                                                                      1. Acceptance Criteria
                                                                      2. Host Cell DNA
                                                                        1. Quantification Methods
                                                                          1. Clearance Studies
                                                                            1. Regulatory Limits
                                                                            2. Endotoxins
                                                                              1. Sources and Detection
                                                                                1. Removal Methods
                                                                                  1. Testing Requirements
                                                                                  2. Viruses
                                                                                    1. Risk Assessment
                                                                                      1. Clearance Validation
                                                                                        1. Testing Strategies
                                                                                      2. Documentation and Compliance
                                                                                        1. Batch Records
                                                                                          1. Documentation Requirements
                                                                                            1. Data Integrity
                                                                                            2. Change Control
                                                                                              1. Change Classification
                                                                                                1. Impact Assessment
                                                                                                  1. Approval Process
                                                                                                  2. Deviation Management
                                                                                                    1. Investigation Procedures
                                                                                                      1. Root Cause Analysis
                                                                                                        1. Corrective Actions
                                                                                                        2. Regulatory Submissions
                                                                                                          1. Filing Requirements
                                                                                                            1. Regulatory Interactions
                                                                                                              1. Post-Market Surveillance

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                                                                                                          8. Process Development and Integration

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                                                                                                          1. Introduction to Downstream Processing