Annex I: Methods & Tools prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 1 ICH Q9 QUALITY RISK MANAGEMENT Annex I.7 Preliminary Hazard Analysis (PHA)

Annex I: Methods & Tools prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 2 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

Annex I: Methods & Tools prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 3 ICH Q9 QUALITY RISK MANAGEMENT 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 Hazard Investigation/ Controls SevFreq Imp (SxF) EXAMPLE

Annex I: Methods & Tools prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 4 ICH Q9 QUALITY RISK MANAGEMENT I.7: Preliminary Hazard Analysis (PHA) Hazards Arising From Product Design Hazard Investigation/ Controls SevFreqImp Wrong Material SOPs, Crosscheck SevRemI Lack of stabilityStability studiesMinOccI EXAMPLE

Annex I: Methods & Tools prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 5 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