Please enable JavaScript.
Coggle requires JavaScript to display documents.
DanburyFacility (General Occupancy (Safety Officer, Janitorial/Maintenance…
DanburyFacility
General Occupancy
Safety Officer
Janitorial/Maintenance/Grounds
Receiving
Admin
Site Manager
HR Ad Hoc?
Security
IT Ad Hoc?
Stage 1: Analytical Development (HPLC for BMT DS & DP, Ciraparantag, etc.)
People
2 People in a Lab
Process
Waste Handling
Chemical Hygiene
Material Storage
Lab Notebooks
Log Books
Quick Calibration Checks (R&D)
Equipment
GC?
Fume Hood
Grounded Waste Area
Remove Plastic Wall?
Data Backup
Stage 2: GXP Lab and Stability
Equipment
2 Chamber Exist
Purchase Another?
Dissolution Equipment (Intrarosa)
Patheon Equipment (Particle Sizer, AA, etc.)
More Fume Hoods
Working Generator
Retain Storage
People
Quality Lead
Same People as Stage 1 (Analysts)
Stability Program Manager
Metrology
Process
Logbook Checks
Full Calibration Program
IQ/OQ of all Equipment
Lab Notebook Reviews
Master Control Recipes?
Sample Receiving
HPLC Column Serial Number
Barcoding Process
PM Program
Stability Chamber Alarming
Reference Standards
Retains
Temperature Controls in Lab
Stage 3: Clinical Packaging
People
Contract Staff
Supervisor
Quality Head (from Stage 2)
Process
Hand Label vs Automated
Material Flow
Staging
Qualify Temperature Control/Ranges
Equipment
Label Printer (currently have)
Walk-In Fridge
Product Storage
Tables
Facility Temperature Monitoring
Additional Cages
Stage 4b: Clinical Production (Aseptic)
People
2 Operators
Supervisor
Quality from Stage 2
Process
Autoclave Cycle Qualifciation
Material & Personnel Flow
Environmental Monitoring
Compounding Only with Isolators Installed
Equipment
Isolators
WFI System
Compounding Tank
HVAC Leaks
Stage 5: Commercial Production