RISK BASED APPROACH TO GMP MANUFACTURING FACILITY DESIGN: THE FUTURE OF ...
9/28/2018
RISK BASED APPROACH TO GMP MANUFACTURING FACILITY DESIGN:
THE FUTURE OF BIOPHARMA MANUFACTURING
Jim Levin ISPE Product Show Track 2, Session 2 September 26, 2018
Risk Based Approach to GMP Manufacturing Facility Design
Introduction
> What is risk? > What does it have to do with manufacturing? > How do we identify and mitigate risk? > How does it impact facility design?
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WHAT IS RISK?
9/28/2018
What is risk?
> Risk
A situation involving exposure to danger.
> Danger
The possibility of suffering harm, or The possibility of something unwelcome or unpleasant.
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Kinds of risk?
> Perceived
An emotional interpretation of risk
> Real
Fact driven interpretation of risk
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Kinds of risk:
Overt Risk
> Perceived
A risky venture: High likelihood of death
> Real
Less than driving a car (0.0007% vs. 0.0167%)
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Kinds of risk:
Hidden risk
> Perceived
Fun, Scary, Safe Ride
> Real
Highest risk of injury in Florida Theme Parks*
*Orlando Sentinel May 21, 2018
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Kinds of risk:
Outcomes
> Automobiles
Fatalities: 1.12 per 100 million VMT 2017: 40,100 fatalities in US More injuries then deaths
> Planes
Fatalities: 0.25 per 100 million flights 2017: Zero fatalities in US More deaths then injuries
*Orlando Sentinel May 21, 2018
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Kinds of risk:
Perception
> Our ability to perceive risk is colored by our concerns for type and amount of harm that might happen, as well as our individual experiences with that risk
> Often disconnected from real risk probability and outcomes
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What is Risk?
Formal Definition: ? ISO 31000 defines Risk as:
"the effect of uncertainty on objectives..."
Working Definition: ? Risk is:
A measure of the importance of an event that includes both the factors of Impact and Probability
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