On Friday, 15 February 2008, the European Commission published a modified
version of Chapter 1 "Quality Management" of the EC GMP Guide (Part 1) together
with Annex 20.
With this publication, the European Commission implants ICH Q9
"Quality Risk Management" into European legislation. According to the statutes
of ICH, each of the 3 regions (USA, Europe, and Japan) has to implant the ICH
guidelines into national legislation (Step 5). The question of how this is done
lies within the responsibility of the respective regions/countries. In Europe,
it has been decided that ICH Q9 shall be published as Annex 20. For this
purpose, the wording of Q9 has been adopted identically. Only the introduction
was added as a new element.
At the same time, the European Commission has amended Chapter 1
with a passage on "Quality Risk Management". This passage points out that the
principles of Quality Risk Management can now be found in Annex 20.
Interestingly, the EU has changed and complemented the text compared to the
draft published in 2007. One noticeable sentence that has been added says that
the principles of Quality Risk Management can be applied both proactively and
Another innovation is the wording on Annex 20, claiming that
the latter does not define any new requirements. Nevertheless, it hardly seems
possible in practice not to implement the application of the "recommendation".
This effect is reinforced by the fact that the changes to Chapter 1 are not to
be understood as recommendations. In some European countries, like Germany for example,
the implementation of the contents of the EC GMP Guide is mandatory. In the
following we have compiled the changes to Chapter 1.
Quality Risk Management
1.5 Quality risk management is a systematic process for the assessment, control,
communication and review of risks to the quality of the medicinal product. It
can be applied both proactively and retrospectively.
1.6 The quality risk management system should ensure that
- the evaluation of the risk to quality is based on
scientific knowledge, experience with the process and ultimately links to
the protection of the patient
- the level of effort, formality and documentation of the
quality risk management process is commensurate with the level of risk
Examples of the processes and applications of quality risk
management can be found inter alia in Annex 20.