EMEA work programme on quality issues for 2009

The annual list of priorities and intended work on pharmaceutical quality issues for the Quality Working Party of the European Medicines Agency (EMEA) in 2009 has been published on the web

As has been mentioned in this column previously, this always allows stakeholders a valuable insight into the projected work of EMEA on quality issues in the coming year and to anticipate areas of activity in this field.

As may have been anticipated, a good proportion of the work programme for 2009 revolves around the implementation and application of new technologies and in particular their impact on current quality guidelines.

In this respect a concept paper on the revision of the guideline on parametric release was recently issued for comment until February 2009.

Guidelines that may be reviewed under this process include those on specifications, process validation and chemistry of new active substances.

Other topics on which draft new guidelines are expected include pharmaceutical development of medicines for paediatric use and setting of specifications for related impurities in antibiotics.

EMEA will also continue its involvement in the quality activities of the International Conference on Harmonisation (ICH). Among the issues in which it will be particularly active are the development of an annex to ICH quality guideline Q8 on Product Development and in the development of a new ICH quality guideline Q11 on the Development and Manufacture of the Active Substance.

It is a busy programme and will necessitate significant input and activity by all stakeholders and we will review in this column its progress throughout the year.