Recent GMP developments in the EU
February 2008 saw a flurry of activity in the EU on the Good Pharmaceutical Manufacturing Practice (GMP) front, with several important announcements by the European Medicines Agency (EMEA) on GMP issues.
February 2008 saw a flurry of activity in the EU on the Good Pharmaceutical Manufacturing Practice (GMP) front, with several important announcements by the European Medicines Agency (EMEA) on GMP issues.
A number of these relate to changes to the EU GMP Guidelines - either adopted or under discussion.
One of the issues of particular interest to industry is the proposed revision to the provisions of the Guidelines on requirements for dedicated facilities for certain products. In a recent statement on the status of revision of Chapter 5 of the GMP Guide concerning 'dedicated facilities', EMEA advises that due to the exceptional interest and debate on a previous EMEA Concept Paper on this issue, originally anticipated timelines for the progress of the revision have slipped.
The statement indicates that the Inspectors" Group of EMEA feels at this time that certain products should be required to be manufactured in dedicated facilities, although these compounds are as yet not identified. The need for dedicated facilities for other compounds of concern would be determined following a thorough quality risk management process.
It is expected that a document will be submitted to the European Commission for issue for public consultation later this year or early next year. This is a topic of considerable interest to ABPI members and no doubt this column will return to the issue at a later date.
Also issued is a notice that the revision to the provisions on Sterile Products contained in Annex 1 to the Guidelines has now been adopted. This updates guidance on environmental cleanliness of cleanrooms, media simulations, bioburden monitoring and capping of freeze dried vials. The new guidance comes into effect on 1 March 2009 except that on capping, which comes into effect on 1 March 2010.
EMEA has also announced the incorporation of ICH Quality Guideline Q9 on Quality Risk Management into European Guidance as Annex 20 to the EU Guidelines, although stressed that this is intended not as a new regulatory burden but rather as an informative resource on risk management methods.
The progress of the implementation these provisions will be monitored with interest by all concerned.