Annex II: Potential Applications 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 II. 2 Quality risk management as part of… Regulatory operations Inspection and assessment activities Competent Authorities Industry

Annex II: Potential Applications 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 II.2: QRM as Part of regulatory operations Inspection and assessment activities  To assist with resource allocation including e.g. >Inspection planning >Inspection frequency >Intensity of assessment and inspection >(see "Auditing" section in Annex II.1)  To evaluate the significance of e.g. >Quality defects >CAPA following a recall >Inspectional findings ICH Q9

Annex II: Potential Applications 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  Target: Develop criteria, which can (easily) be evaluated/maintained by members of the department responsible for the audit plan…. See previous section II.1: auditing / inspection EXAMPLE Scheduling Inspections

Annex II: Potential Applications 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 II.2: QRM as Part of regulatory operations Inspection and assessment activities  To determine the appropriateness and type of post-inspection regulatory follow-up  To evaluate information submitted by industry including pharmaceutical development information  To evaluate impact of proposed variations or changes  To identify risks which should be communicated >between inspectors and assessors  To facilitate better understanding >how risks can be or are controlled (e.g., parametric release, Process Analytical Technology (PAT) ICH Q9