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The Technical Regulatory Expectations
in Development and Manufacture of Bio
Course Content:
The Development Plan
Product Requirements and Characteristics
- Physicochemical
- Biological
Specification and Qualification of
- Product Host Cell
- Raw Materials and Components
Development of Product Reference Standard
Development and Validation of Analytical Methods
Stability Testing Program
Establishment of Master and Working Cell Banks
Development of the Manufacturing Process
Development of Process Specifications
Scaleup to Pilot Plant Size
Standard Operating Procedures
- Analytical Testing
- Materials Handling
- Production
- QC
- Maintenance
- QA Procedures
The Master Batch Production Record
Documentation of the Development Progress
Assignment of Responsibilities
- Materials Handling
- Production
- Maintenance
- Quality Control
- Quality Assurance
- Regulatory Affairs
- Executive Management
Production Facility
- Design Requirements
- Flow of Personnel, Materials, Equipment, Product and Waste
- HVAC and Architectural Finishes
- Utilities
- Dedicated Facilities vs. Multi-Product Facilities
Facility Validation
- Design Qualification
- Construction Qualification
- Operation Qualification
- Performance Qualification
Process Validation
- Design Qualification
- Installation Qualification
- Operation Qualification
- Computer Validation
- Cleaning Validation
- Performance Qualification
Personnel
- Training
- Qualification
Manufacture for Clinical Trials
Scaleup to Commercial Production Size
Contract Production
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