European Medicinal Agency publishes its Works Plan for GMP/GDP Inspectors Working Group for 2015

European Medicinal Agency published its Works Plan for GMP/GDP Inspectors Working Group for 2015. Working group develops procedure and co-ordinate inspections of firms. This will also include contributing as needed in the EU regulatory networks response to crises resulting from serious quality/manufacturing problems and/or GMP non-compliance. It also identifies GMP and GDP topics for guideline development or clarification.

The GMP topics identified for 2015 are:

  • GMP guide: annex 1 - To provide a draft text for public consultation.

  • GMP guide: annex 13 - To update the annex in the light of the new clinical trials regulation. Collaboration is envisaged with the Committee for Advanced Therapies (CAT).

  • GMP guide: annex 15 (validation) - To finalise the revision to update guidance including any necessary changes to maintain consistency with the new CHMP guideline on process validation in the light of ICH Q8, Q9, Q10.

  • GMP guide: annex 17 (parametric release) - To finalise the revision aimed at updating this annex.

  • GMP guide: annex 21 (New: Importation of medicinal products) - To prepare a Concept Paper and to provide a draft text for public consultation; Work plan for GMP/GDP Inspectors Working Group for 2015 EMA/INS/GMP/719216/2014 Page 4/5 Note: In accordance with the cooperation agreement with PIC/S, non-EEA participation in drafting groups will be sought for documents identified as harmonised.

  • EudraGMDP database
    - To continue to oversee the EudraGMDP database and to act upon the recommendations of the EudraGMDP IT subgroup formed to advise the group;
    - To continue to press Mutual Recognition Partners to use the database as the mechanism for exchange of information rather than paper;
    - To evaluate the effectiveness of the planning module as a tool for international collaboration and to find a common solution for unique site identifiers.

You can view the full work plan Click here.