The document discusses risk management in pharmaceutical manufacturing. It suggests that traditional approaches to risk management rely too heavily on the idea that if something hasn't failed yet, it poses no risk, and that compliance is sufficient regardless of actual risks. It advocates moving towards a more proactive approach that focuses on identifying, assessing, managing and mitigating risks through steps like increased separation of personnel and use of barrier systems in aseptic processing to strengthen sterility assurance.

1. Pharmaceutical Microbiology
Multidisciplinary Integrated Approach in Drug Manufacturing
Obaid Ali & Roohi B. Obaid
Civil Service Officers, Government of Pakistan
3/5
Risk Management

2. When calculated risk is the only option
Each and every caution is indispensible

3. 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

4. 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

5. RISK

6. RISK
S
E
V
E
R
I
T
Y

7. RISK
P
R
O
B
A
B
I
L
I
T
Y

8. RISK
D
E
T
E
C
T
A
B
I
L
I
T
Y

9. T
O
T
A
L
S D P

10. T
O
T
A
L
S D P
Identify Assess Manage Mitigate

11. T
O
T
A
L
S D P
Identify Assess Manage Mitigate

12. T
O
T
A
L
S D P
Identify Assess Manage Mitigate

13. T
O
T
A
L
S D P
Identify Assess Manage Mitigate

14. Lets see how it works
Road Traffic Pedestrian

15. Lets see how it works
Without
Stop Board
With
Stop Board

16. Lets see how it works Stop Sign
Light
Pedestrian
sign
Back
Counting
Severity

17. Lets see how it works Stop Sign
Light
Pedestrian
sign
Back
Counting
Probability

18. Lets see how it works Stop Sign
Light
Pedestrian
sign
Back
Counting
Detectability

19. Step by step with confidence to strengthen certainty
Method of Sterilization

20. Heat
sensitive
Unstable to
temperature

21. Towards stringent control, not otherwise
Compendial requirements are the minimum standards
Where we have an option to choose

22. Aseptic processing proven safe but not sterile
IncreasedseparationofPersonnel
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

23. What happens if there is fire ?
Alarm React
Glass
breaking
Etc. etc.

24. Freedom from Road Blocks
Come out from traditional
approach of intellectual block
Be proactive in using technical
knowledge
Live safe and keep moving
forward