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Pharmaceutical MicrobiologyMultidisciplinary Integrated Approach in Drug Manufacturing
Obaid Ali & Roohi B. ObaidCivil Service Officers, Government of Pakistan
3/5Risk Management
When calculated risk is the only option
Each and every caution is indispensible
If something has not happened yet, it will likely not happen
Design may be flawed, but there is no evidence that there is a problem
If something has not been identified by inspector, it is ok
Passing the media fill assures process control
Lets correct, it is misconception
Sterility test has not yet failed but reason of pass is not defendable
We are complying and it is enough, no matter what you are referring
Traditional approach is a good approach
Insulin was filled in an area under exhaust fans in history
Lets correct, it is misconception
RISK
RISKSEVERITY
RISK
PROBABILITY
RISK
DETECTABILITY
TOTAL
S D P
TOTAL
S D P
Identify Assess Manage Mitigate
TOTAL
S D P
Identify Assess Manage Mitigate
TOTAL
S D P
Identify Assess Manage Mitigate
TOTAL
S D P
Identify Assess Manage Mitigate
Lets see how it works
Road Traffic Pedestrian
Lets see how it works
Without Stop Board
WithStop Board
Lets see how it works Stop Sign
Light
Pedestrian sign
Back Counting
Severity
Lets see how it works Stop Sign
Light
Pedestrian sign
Back Counting
Probability
Lets see how it works Stop Sign
Light
Pedestrian sign
Back Counting
Detectability
Step by step with confidence to strengthen certaintyMethod of Sterilization
Heat sensitive
Unstable to temperature
Towards stringent control, not otherwise
Compendial requirements are the minimum standards
Where we have an option to choose
Aseptic processing proven safe but not sterile
Incr
ease
d se
para
tion
of P
erso
nnel
Increased confidence in Sterility Assurance
Manual aseptic fill
Conventional aseptic fill
Barrier System
Open RABS
Closed RABS
Open Gloved Isolator
Closed Glove Isolator
Glove-less Isolator
What happens if there is fire ?
Alarm React
Glass breaking Etc. etc.
Freedom from Road Blocks
Come out from traditional approach of intellectual block
Be proactive in using technical knowledge
Live safe and keep moving forward
