EMEA Publishes 2007 Work Plan for Ad Hoc GMP Inspection Services Group

GMP News No. 892: EMEA Publishes 2007 Work Plan for Ad Hoc GMP Inspection Services Group

GMP News
21 February 2007
 

EMEA Publishes 2007 Work Plan for
Ad Hoc GMP Inspection Services Group

 
On 9 February the European Medicines Agency (EMEA) has published its work plan for the ad hoc GMP Inspection Services Group for the year 2007. This document summarises the planned activities of the respective services group and gives a comprehensive overview of what the pharmaceutical industry can expect this year. For example, activities regarding inspections under the centralised system are summarised and the current status of the MRAs is listed.

As the following overview shows, quite a few Annexes to the EC GMP Guide are going to be revised or amended:

The ongoing revision of Annex 1 will be finalised (comment: Text expected for publication by the third quarter of 2007. Consideration is being given to an extended implementation period.)

For Annex 2 it is planned to further develop the amendment of the annex in order to update the annex, to integrate proposals for advanced medicinal products and to clarify the GMP requirements for biological substances in view of the restructuring of the GMP Guide (comment: text for public consultation expected by mid 2007.)

Initiated in view of the restructuring of the GMP Guide and to update the Annexes 3 and 6 it is also planned to finalise the respective amendments, (comment: for Annex 3 the text is undergoing public consultation, for Annex 6 a text for public consultation is expected by mid 2007.)

Also initiated in view of the restructuring of the GMP Guide and the Directive 2004/24 (Traditional Herbal Medicinal Products) the amendment of Annex 7 is also supposed to be finalised. This will include consulting the Quality Drafting Group of the Committee for Herbal Medicinal Products as necessary (comment: Text expected to be published by mid 2007.)

Once the issues surrounding the overlap between Directives 2002/98/EC and 2001/83/EC are resolved, it is further planned to complete the amendment of Annex 14 which was initiated in view of Directive 2002/98/EC. However, it still needs to be decided whether the Annex should be subsumed into Annex 2 or not.

In Annex 16 the principles of the proposed solution on "QP discretion" (Compliance with the requirements of the marketing authorisation) will be incorporated, taking into account the proposed revision of the Variations Regulation. See also section 6 (comment: Public consultation unlikely in 2007.)

You can find the whole document here: http://www.emea.eu.int/Inspections/docs/GMP_Workplan_2007.pdf
 

If you are interested in learning more about both preparing for inspections and performing audits, and if you also want to get an EU Inspectors insight, consider the 3-day ECA Education Course How to Pass EU and FDA Inspections & GMP-Compliance Auditor Course, from 29-31 October 2007 in Vienna, Austria.

 
Prepared by:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)
  

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