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Annex I: Methods & Tools

ICH Q9 QUALITY RISK MANAGEMENT

Annex I.7

Preliminary Hazard
Analysis
(PHA)

prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 1
Annex I: Methods & Tools
ICH Q9 QUALITY RISK MANAGEMENT

I.7: Preliminary Hazard Analysis (PHA)


(ISO14971)
Analysis based on applying prior experience or knowledge
of a hazard or failure to identify future hazards, hazardous
situations and events that can cause harm
In estimating their probability of occurrence for a given
activity, facility, product or system
How to perform?
Identification of the possibilities that the risk event happens
Qualitative evaluation of the extent of possible
injury or damage to health that could result
Identification of possible remedial measures
ICH Q9
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 2
Annex I: Methods & Tools
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE

I.7: Preliminary Hazard Analysis (PHA)


The steps Hazards Arising From Product Design
Risk Matrix Form Investigation/ Imp
Hazard Sev Freq
Controls (SxF)
> List known
potential hazards
- Literature
- Previous projects
- Reportable events
- Complaints
Severity rankings
Frequency codes and estimates risk codes
Once established should remain same for similar product
classes
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 3
Annex I: Methods & Tools
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE

I.7: Preliminary Hazard Analysis (PHA)

Hazards Arising From Product Design


Investigation/
Hazard Sev Freq Imp
Controls
SOPs,
Wrong Material Sev Rem I
Crosscheck
Lack of stability Stability studies Min Occ I

prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 4
Annex I: Methods & Tools
ICH Q9 QUALITY RISK MANAGEMENT

I.7: Preliminary Hazard Analysis (PHA)

Potential Areas of Use(s)


Analyzing existing systems
Prioritizing hazards
Evaluate the types of hazards for the general product
type, then the product class and finally the specific
product
Early in the development: little information on design
details or operating procedures will often be a
precursor to further studies
For product, process and facility design
Further assessed with other risk management tools
ICH Q9
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 5