Chapter 1: Lifecycle Approach to Process Validation Process Validation Stages Auxiliary Programs Supporting Lifecycle Process Validation Regulatory Requirements Chapter 2: Solid Dose Formulations Tablets Tablet Manufacturing Processes Capsules Capsule Manufacturing Process Chapter 3: Stage 1A Process Design: Quality by Design Quality Target Product Profile (QTPP) Critical Quality Attributes (CQAs) Critical Material Attributes (CMAs) Critical Process Parameters (CPPs) 8 Design of Experiments (DoE) Control Strategy (CS) Process Capability and Continual Improvement Chapter 4: Knowledge Management and Risk Assessment for Lifecycle Stages Knowledge Base for Development ICH Q9 Quality Risk Management Design Space Chapter 5: Stage 1B Process Scale-Up Considerations Process Scale-Up Studies Control Strategy Components Chapter 6:Stage 2A and Stage 2B: Process Qualification Stage 2A- Design and Qualification of the Facility, Equipment and Utilities Technology Transfer Considerations Checklist Prior to Initiating Stage 2B Stage 2B- Process Performance Qualification Chapter 7: Stage 3A and Stage 3B: Continued Process Verification Benefits of Continued Process Verification Program Continued Process Verification Stage 3A Continued Process Verification Stage 3B. ICH Guidance's working in tandem ukryj opis