Quality Validation
The following activities will occur to support the equipment installation:
- Plant Steam System.
- Pure Steam System.
- Compressed Air Systems.
- Instrument Air System.
- Chilled Water System.
- Heating Hot Water System.
- Distilled Water System.
- WFI System.
- Air handling unit
- Laminar Air Flow (LAF) unit.
- Autoclave.
- Parts Washer.
- Heat Sealer
- SCADA system to monitor environmental conditions (differential pressure, humidity, temperature) of room and HVAC controls.
- D3 system to control cleaning recipes, including event archiving, data historian and batch reporting.
- Fill @ Finish (Compact lines)
- Serialization and Aggregation
- Traceability Matrix
- Reactors
- Freezers
- Hot Air Dryer
- Tunnels
- Warehouse Temperature Mapping
- Clean Rooms and EMPQ
Building Management System
Manufacturing, Processing, and Packaging Development
- Formulation Development
- Pilot Batches
- Process and Packaging Development
- Technical Technology Transfer (TTT)
- Product Life-Cycle Management (PLCM)
- Quality-by-Design (QbD)
- Schematic Diagram
- Submission Files
- New Product Launch