Risk Assessment Table – APF IV Production Department
Ris Process Step Potential Risk Potential Impact Current Recommend
k ID Hazard / Description Control ed
Risk Measures Mitigation
Actions
R1 Raw Material Contaminatio Use of non- Contaminated IV Supplier
Handling n of raw sterile or fluid batch, qualification,
materials improperly potential harm to quarantine of
cleaned patients materials,
materials QA approval
R2 Dispensing Incorrect Weighing or Incorrect Double-
and Mixing quantity of dispensing formulation, checking,
API errors, patient safety risk calibrated
Inadequate balances,
mixing SOPs
R3 Filtration Filter Use of Microbial or Integrity
integrity damaged or particulate testing pre &
failure incompatible contamination post use, filter
filter, using a validation
single filter for
more than the
recommended
cycles
R4 Filling Microbial Filling machine Non-sterile Grade A/C
contaminatio malfunction, product, risk of cleanroom,
n Contaminants infection to the laminar
entering open patient airflow,
product during environmental
filling monitoring
R5 Sterilization Inadequate Autoclave Non-sterile final Validation of
(Autoclaving) sterilization machine product autoclave
failure,
Incomplete
cycle
R6 Unloading IV bags Product mix- Mix up may Potential hazard Labeling each
up or IV bag occur when due to product drum
damage unloading from mis- containing the
trolley, IV bag identification, same batch
damage during contamination during
unloading due unloading
to adhesion to
one another
R7 Leakage Test Compressed Poor IV bag Contamination of Correction of
air pressure integrity and the adjacent compressed
failure unable to product during air pressure
handle pressure shipping, poor and re testing
during shipping product quality, the product
and microbial
transportation contamination
R8 Labeling Ineligible Due to video jet Hard to track or Label
labeling malfunction, recall products, reconciliation
personal error Misidentification
in changing the of the product
label at the end
of every batch
R9 Sealing Incomplete Leaks or Risk of Visual
sealing of compromised contamination, inspection,
PVC bag sterility adherence of IV sealing
with PE bag bags with one equipment
another calibration
R10 Environmental Undetected Monitoring Increased Routine
Monitoring contaminatio lapses or microbial load in monitoring,
n equipment critical areas esp. alert/action
failure filling room limits
R11 Equipment Cross- Improper Contamination of Cleaning
Cleaning contaminatio cleaning of next batch SOPs ,
n mixing tanks, verification
lines logs
R12 Operator Handling Human error Poor aseptic Contamination, Aseptic
or poor practices or batch failure, technique
hygiene procedural safety risk training,
lapses gowning
SOPs
R13 Deviations/Change Poor Uncontrolled Repetition of Deviation
Control documentatio changes or failures, non- logs, CAPA
n of incomplete root compliance system
deviations cause analysis
R14 Utility Systems System Microbial Risk to sterile Periodic
(WFI, HVAC) failure or growth in WFI environment or validation,
contaminatio or HVAC product maintenance
n malfunction
