Annex II: Potential Applications

ICH Q9 QUALITY RISK MANAGEMENT

II. 8 Quality risk management as part of…

Industry

Packaging Competent
Authorities

and
labeling

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

QRM as part of packaging and labelling

 Design of packages
> Design the secondary package for the protection of
primary packaged product
 Ensure product authenticity
 Label legibility

 Selection of container closure system

> Determine the critical parameters
of the container closure system

ICH Q9
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 2
Annex II: Potential Applications
ICH Q9 QUALITY RISK MANAGEMENT

QRM as part of packaging and labelling

 Label controls

> Design label control procedures

based on the potential for mix-ups

 Involving different product labels

 Including different versions of the same label

ICH Q9
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 3