Annex I.7

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Annex I.7

• Preliminary Hazard Analysis (PHA)

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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
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I.7 Preliminary Hazard Analysis (PHA)

• The steps
• Risk Matrix Form
• 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

Hazards Arising From Product Design Hazards Arising From Product Design Hazards Arising From Product Design Hazards Arising From Product Design Hazards Arising From Product Design
Hazard Investigation/ Controls Sev Freq Imp(SxF)





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I.7 Preliminary Hazard Analysis (PHA)
Hazards Arising From Product Design Hazards Arising From Product Design Hazards Arising From Product Design Hazards Arising From Product Design Hazards Arising From Product Design
Hazard Investigation/ Controls Sev Freq Imp
Wrong Material SOPs, Crosscheck Sev Rem I
Lack of stability Stability studies Min Occ I



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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