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Existing Facility/Large product prortfolio, High risk compound - Coggle…
Existing Facility/Large product prortfolio
Risk assessment
Risk analysis for highest risk compound
mix up
retention
mechanical transfer
airborne transfer
data for highest risk compound
layout
personal/material/pressure
SOP
risk management
labeling
line clearance
man material movement
Cleaning and cleaning validaition
HVAC maintenance
Gowning/gloving
historical data
cleaning results
alarm reports
audit results
Regulatory action
Incident reports
Deviations
Change control list
background information
32 products/10 APIs
ADE/BS/Product contact area/Limit detection/Batch per year
Cleaning limit
min value => AC + visual
limit of detection
need to be les than cleaning limit
if LOD > cleaning limit
pull out scenario for increasing new cleaning limit
High risk compound
ADE
% API
Volume/ Frequency manucfactured
Process properties