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