European inspectors set out their work plan for 2010
The annual work plan for 2010 of the Good Manufacturing Practice/Good Distribution Practice (GMP/GDP) Inspectors Working Group of the European Medicines Agency (EMA) was published in January 2010. The proposed agenda indicates that 2010 will be a busy year, with a number of topics identified for action.
With regard to reinspection of manufacturers in third countries, the Inspectors state that they intend to ensure that manufacturing sites listed on centralised marketing authorisations and located in third countries where no Mutual Recognition Agreement (MRA) is in place are reinspected by, or on behalf of, the Supervisory Authority within the criteria agreed at Community level.
On the question of MRAs there are a number of objectives set out on MRAs in general. Among these is an intention to include active substances in the operational phase of the current scope of the MRAs and to liaise with MRA partners on information exchange and collaboration on inspections performed outside of the respective territories.
As usual, the Inspectors set out their plans for updating of GMP guidelines during the year. Identified as priorities for 2010 are Chapters/Annexes on quality management and personnel, premises and equipment and production, contract manufacture and analysis, complaints and product recall, computerised systems and GDP. There are a number of other areas for review identified but these are listed as "Low Priority".
This indication by the inspectors of its priorities for the year is always appreciated by industry and, as suggested above, the new document presents a very full programme for the year and progress on the initiatives will be reviewed in due course.