CHAPTER 1: INTRODUCTION TO BIOMANUFACTURING
1.1 Overview of Modern Biomanufacturing Principles
1.2 Overview of Biomanufacturing
1.3 The Quality by Design Approach
1.4 Technical Considerations in Biomanufacturing
1.5 Phases and Scale-Up in Biomanufacturing
1.6 Lifecycle of Manufacturing
1.7 Integration of Artificial Intelligence in Biomanufacturing
CHAPTER 2: RAW MATERIAL AND COMPLIANCE IN BIOMANUFACTURING
2.1 Raw Material Considerations in Biomanufacturing
2.2 Compliance and Quality in Biomanufacturing
2.3 Lean Biomanufacturing
2.4 Artificial Intelligence in Raw Material Management
2.5 Predictive Analytics for Raw Material Quality and Supply Chain Optimization
2.6 Advanced Technologies and Future Directions in Biomanufacturing
CHAPTER 3: PROCESS ANALYTICAL TECHNOLOGY (PAT)
3.1 Background and Need for PAT
3.2 Tools for Data Acquisitions
3.3 Software in Fermenters, Flow Filtrations, Chromatography
3.4 Analysis and Design Process Analyzers
3.5 Process Control Tools
3.6 Continuous Improvement and Knowledge Management
3.7 Artificial Intelligence in Process Analytical Technology
3.8 Enhancing data acquisition and process control through machine learning algorithms
CHAPTER 4: STANDARD OPERATING PROCEDURES IN BIOTECHNOLOGY
4.1 Upstream Processing of Proteins
4.2 Downstream Processing of Proteins
4.3 Quality Control of Protein Production
4.4 Final Fill and Finish of Product
4.5 Case Studies: Therapeutic Proteins, Monoclonal Antibodies, Human Vaccines
4.6 Artificial Intelligence for Standard Operating Procedures Optimization
4.7 Automating and optimizing SOPs using AI technologies
CHAPTER 5: INTRODUCTION TO QUALITY SYSTEMS
5.1 Main Elements of a Quality System
5.2 Essentials of a Quality System
5.3 Practical Implementation of a Quality System
5.4 Structure of a Quality Manual
5.5 Correlation between GMP Requirements (WHO) and ISO 9001:2000
5.6 Artificial Intelligence in Quality Systems
5.7 Leveraging AI to ensure continuous compliance and improvement in quality systems
CHAPTER 6: PRINCIPLES AND PRACTICE OF GMP: PERSONNEL AND PREMISES
6.1 Principles of Human Resource Management
6.2 Duties of Senior Management
6.3 Organizational Structures
6.4 Qualification and Profiles Requirement
6.5 Workplace and Job Descriptions
6.6 Health Monitoring and Occupational Health Safety
6.7 Training and Functions Owners Subject to Public Law
6.8 Official Requirements for Premises
6.9 Material & Personnel Flow and Layout
6.10 Air Cleanliness Classes and Grades
6.11 Construction Elements and Barrier Systems
6.12 Artificial Intelligence in Personnel Management and Premises
6.13 AI applications in optimizing HR functions and premises management
CHAPTER 7: FACILITIES, EQUIPMENT, AND PHARMACEUTICAL WATER
7.1 Facility Planning and Materials
7.2 Hygienic Design in Solids Handling
7.3 System Controllers and Process Control Systems
7.4 Technical Documentation, Calibration, and Maintenance
7.5 Cleaning of Facilities and Containment in Solids Handling
7.6 Pharmaceutical Water: Qualities, Generation, Distribution, and Storage
7.7 Qualification and Operation of Water Supplies
7.8 Pure Steam Systems
7.9 Artificial Intelligence in Facility Management
7.10 Using AI for predictive maintenance and efficient facility operations
CHAPTER 8: QUALIFICATION AND PROCESS VALIDATION
8.1 Official Requirements for Qualification
8.2 Preparation and Documentation of Qualification
8.3 Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
8.4 Special Cases of Qualification
8.5 Official Requirements for Validation
8.6 Validation Planning and Procedure
8.7 Process Validation and Product Lifecycle
8.8 Cleaning Validation: Master Plan, Scope, Acceptance Criteria, Sampling, Analytical Procedures, Documentation
8.9 Artificial Intelligence in Validation Processes
8.10 Automating qualification and validation processes with AI tools
CHAPTER 9: PRODUCTION, SANITATION, AND STERILE PACKAGING
9.1 Sanitation and Personnel Hygiene
9.2 Production Hygiene and Environmental Monitoring
9.3 GMP in the Production Process
9.4 Weigh-In, Identification, and In-Process Control
9.5 Prevention of Cross-Contamination, Reworking, Warehouse, and Logistics
9.6 Sterile Production: Air Lock Concepts, Manufacture of Terminally Sterilized Products, Sterilization Processes
9.7 Aseptic Processing and Freeze-Drying
9.8 Testing for Sterility, Endotoxins, Leakage, and Particles
9.9 Microbiological Monitoring
9.10 Packaging Materials and Processes
9.11 Qualification of a Servo-Controlled Blister Packaging Line
9.12 Blow-Fill-Seal (BFS) Technology
9.13 Artificial Intelligence in Production and Packaging: AI for real-time monitoring and control in production and packaging environments
CHAPTER 10: GMP IN REGULATION
10.1 Information on National Bodies and Pharmaceutical Associations
10.2 Overview of Pharmacopeia
10.3 EU Directives and Guidelines
10.4 USA: CFR and FDA Guidelines
10.5 ICH-Guidelines
10.6 PIC/S Guidelines
10.7 GMP of Other Regions
10.8 WHO Guidelines
10.9 Artificial Intelligence in Regulatory Compliance: AI tools for ensuring adherence to regulatory guidelines and proactive compliance
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