Clean Room Design
- Design Reviews
- Process/Material/Personnel Flows
- User Specifications
- Room Data Sheets
- Design Qualification
- Installation/Operational Qualification
- Environmental Monitoring Programs
Validation
- Facilities (New Build or Upgrade)
- Clean Utilities, including High Purity Water Systems, Clean Steam and Clean Gases
- Processing Equipment, including Isolators, RABS and Filling Machines
- Sterilisation, including Depyrogenation and Autoclaving
- Process Qualification, including Process Simulation (Media Fills)
GMP Documentation
- Facility/Equipment Specifications
- Room Data Sheets
- Standard Operating Procedures
- Qualification Protocols
- Impact Assessments
- Risk Assessments
- Quality Investigations
Training
- GMP Documentation
- Cleanroom Operation
- Cleanroom Qualification
- Equipment Operation
- Equipment Qualification
- Process Qualification