Environmental & Facility Qualification
- Temperature Mapping of Storage Areas
- Facility Qualification
- HVAC System Qualification
- Risk Assessment for Environmental Monitoring Sampling Locations
- Cleanroom Grades A, B, C, D (as per EU GMP Annex-1)
OSD Equipment Qualification
Training for qualification and validation of oral solid dosage manufacturing equipment:
- RMG (Rapid Mixer Granulator)
- FBD (Fluid Bed Dryer)
- Blender
- Compression Machine
- Coating Machine
- Blister Packing Machine
- Autocartoner
- Other OSD equipment
Sterile / Injection Equipment Qualification
Equipment used in aseptic manufacturing:
- Autoclave Validation
- Vial/Ampoule Washing Machine
- Depyrogenation Tunnel
- RABS (Restricted Access Barrier System)
- Filling Machine
- CIP / SIP System
- Manufacturing Tank
- Filtration Tank Qualification
- Pass Box / LAF
- Visual Inspection Machine
- Stability Chamber
- Incubator
- BSC (Biological Safety Cabinet)
Lessons:
